FILM: A Study Assessing the Safety and Utility of PINPOINT® Near Infrared Fluorescence Imaging in the Identification of Lymph Nodes in Patients With Uterine and Cervical Malignancies Who Are Undergoing Lymph Node Mapping

• Sponsor: Novadaq Technologies ULC, now a part of Stryker (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02209532
• Collaborator: (none)
• Enrollment: 180
• Locations: 8
• Arms: 2
• Duration (Months): 18
• Patients Per Site: 22.5
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

This is a randomized, prospective, open label, multicenter study to assess the safety and utility of PINPOINT® Near Infrared Fluorescence Imaging (PINPOINT) in identification of lymph nodes (LN) in patients with uterine and cervical malignancies who are undergoing LN mapping.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Cancer; Uterine Cancer; Cervical Cancer	Device: PINPOINT	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Prospective, Open Label, Multicenter Study Assessing the Safety and Utility of PINPOINT® Near Infrared Fluorescence Imaging in the Identification of Lymph Nodes in Patients With Uterine and Cervical Malignancies Who Are Undergoing Lymph Node Mapping
• Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Jun 1, 2017
• Actual Study Completion Date: Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Blue - PINPOINT The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.	Device: PINPOINT; PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
Active Comparator: PINPOINT - Blue The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.	Device: PINPOINT; PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes

Outcome Measures

Primary Outcome Measures

1. Effectiveness of PINPOINT and IC2000 in the Identification of Lymph Nodes Defined as the Proportion of Confirmed Lymph Nodes Identified [Day 0]

   To assess the effectiveness of intraoperative PINPOINT Near Infrared Fluorescence Imaging in the identification of lymph nodes in subjects with uterine and cervical malignancies who are undergoing lymph node mapping.

Secondary Outcome Measures

1. Effectiveness of PINPOINT and Blue Dye in the Identification of at Least One Lymph Node Defined as the Number of Subjects in Which at Least One Confirmed Lymph Node Was Identified With Either PINPOINT or Blue Dye [Day 0]

   To evaluate the effectiveness of PINPOINT and Blue dye in the identification of at least one lymph node (confirmed to be lymphoid tissue) per subject.

2. Effectiveness of PINPOINT and Blue Dye in the Identification of Bilateral Lymph Nodes Defined as the Number of Subjects in Which Lymph Nodes Were Identified Bilaterally With Either PINPOINT or Blue Dye. [Day 0]

   To evaluate the effectiveness of PINPOINT and Blue dye in the identification of bilateral lymph nodes (confirmed to be lymphoid tissue).

3. Identification of Lymph Nodes Following Lymphatic Channels Defined as the Number of Subjects in Which Confirmed Lymph Nodes Were Identified by Following a Lymphatic Channel With Either PINPOINT or Blue Dye. [Day 0]

   To determine the proportion of lymph nodes identified from following lymphatic channels

4. Safety of Interstitial Injection of ICG Defined as the Number of Adverse Effects Related to ICG [Day 0 to Day 30]

   To assess the safety of interstitial injection of ICG for intraoperative lymphatic mapping, as measured by number of subjects experiencing adverse effects related to the study treatment.

5. Anatomic Distribution of Lymph Nodes [Day 0]

   To determine the anatomic distribution of lymph nodes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years of age or older

• Subjects with FIGO Clinical Stage I endometrial cancer undergoing minimally invasive hysterectomy with lymph node mapping.

• Subjects with FIGO Clinical Stage IA cervical cancer ≤ 2 cm in size undergoing minimally invasive hysterectomy, trachelectomy, or conization with lymph node mapping. Subjects with clinical Stage IA1 cervical cancer without lympho vascular space involvement (LVSI) and negative margins on cone biopsy are not to be included.

• Subjects with negative nodal status (N0)

• Subjects with negative metastatic involvement (M0).

Exclusion Criteria:

• Have had prior dissection and/or radiation in pelvis.

• Advanced cervical or endometrial cancer, T3/T4 lesions

• Diagnosis of cervical cancer with a tumor size greater than 2 cm.

• Locally advanced or inflammatory cervical or uterine cancer

• Metastatic cervical or uterine cancer.

• Known allergy or history of adverse reaction to ICG, iodine or iodine dyes.

• Known allergy or history of adverse reaction to Blue dye (Isosulfan blue) or triphenylmethane.

• Hepatic dysfunction defined as MELD Score > 12.

• Renal dysfunction defined as serum creatinine ≥ 2.0 mg/dl.

• Subjects who have participated in another investigational study within 30 days prior to surgery.

• Pregnant or lactating subjects.

• Subjects who, in the Investigator's opinion, have any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	O'Connor Hospital	San Jose	California	United States
2	Lee Memorial Hospital	Fort Myers	Florida	United States
3	Memorial Sloan Kettering	New York	New York	United States
4	Duke Cancer Institute	Durham	North Carolina	United States
5	MD Anderson Cancer Center	Houston	Texas	United States
6	Sunnybrook Health Science Centre	Toronto	Ontario	Canada
7	CHU de Québec - Université Laval	Quebec City	Quebec	Canada
8	Hospital HIMA San Pablo	Caguas		Puerto Rico

Sponsors and Collaborators

• Novadaq Technologies ULC, now a part of Stryker

Investigators

• Principal Investigator: Michael Frumovitz, MD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

• Study Protocol - Aug 25, 2017
• Statistical Analysis Plan - Jun 23, 2017

More Information

Publications

None provided.

• Responsible Party: Novadaq Technologies ULC, now a part of Stryker
• ClinicalTrials.gov Identifier: NCT02209532
• Other Study ID Numbers: PP LNM 01
• First Posted: Aug 6, 2014
• Last Update Posted: Mar 25, 2019
• Last Verified: Mar 1, 2019

• Keywords provided by Novadaq Technologies ULC, now a part of Stryker: Lymph node mapping; Endometrial cancer; Uterine cancer; Cervical cancer
• Additional relevant MeSH terms: Uterine Cervical Neoplasms; Endometrial Neoplasms; Uterine Neoplasms

Study Results

Participant Flow

Arm/Group Title	Lymph Node Mapping With Isosulfan Blue Followed by PINPOINT	Lymph Node Mapping With PINPOINT Followed by Isosulfan Blue
Arm/Group Description	The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes	The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
Period Title: Overall Study
STARTED	90	90
COMPLETED	87	89
NOT COMPLETED	3	1

Baseline Characteristics

Arm/Group Title	Blue - PINPOINT	PINPOINT - Blue	Total
Arm/Group Description	The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes	The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes	Total of all reporting groups
Overall Participants	87	89	176
Age, Customized (Count of Participants)
30-39	3 3.4%	4 4.5%	7 4%
40-49	6 6.9%	4 4.5%	10 5.7%
50-59	20 23%	26 29.2%	46 26.1%
60-69	33 37.9%	41 46.1%	74 42%
70-79	20 23%	12 13.5%	32 18.2%
>80	5 5.7%	2 2.2%	7 4%
Sex/Gender, Customized (Count of Participants)
Female	87 100%	89 100%	176 100%
Race/Ethnicity, Customized (Count of Participants)
White	66 75.9%	73 82%	139 79%
Black or African American	5 5.7%	2 2.2%	7 4%
Asian	4 4.6%	2 2.2%	6 3.4%
Other	2 2.3%	0 0%	2 1.1%
Smoking Status (Count of Participants)
Never	66 75.9%	65 73%	131 74.4%
Current	2 2.3%	5 5.6%	7 4%
Past	19 21.8%	19 21.3%	38 21.6%
Alcohol Consumption (Count of Participants)
Yes	34 39.1%	31 34.8%	65 36.9%
No	53 60.9%	58 65.2%	111 63.1%
ASA Classification (Count of Participants)
I - A normal healthy patient	10 11.5%	11 12.4%	21 11.9%
II - A patient with mild systemic disease	38 43.7%	39 43.8%	77 43.8%
III - A patient with severe systemic disease	34 39.1%	32 36%	66 37.5%
Unknown ASA Classification	5 5.7%	7 7.9%	12 6.8%
Preoperative Diagnosis (Count of Participants)
Stage 1 Endometrial Cancer	84 96.6%	85 95.5%	169 96%
Stage 1 Cervical Cancer	2 2.3%	2 2.2%	4 2.3%
Stage 1A Cervical Cancer	3 3.4%	2 2.2%	5 2.8%
Endometrial Cancer Histology (Count of Participants)
Adenocarcinoma	71 81.6%	75 84.3%	146 83%
Serous Carcinoma	7 8%	6 6.7%	13 7.4%
Clear Cell Carcinoma	4 4.6%	0 0%	4 2.3%
Carcinosarcoma	1 1.1%	2 2.2%	3 1.7%
Other	1 1.1%	2 2.2%	3 1.7%
Cervical Cancer Histology (Count of Participants)
Squamous Cell Carcinoma	0 0%	3 3.4%	3 1.7%
Adenocarcinoma	3 3.4%	1 1.1%	4 2.3%

Outcome Measures

1. Primary Outcome

Title	Effectiveness of PINPOINT and IC2000 in the Identification of Lymph Nodes Defined as the Proportion of Confirmed Lymph Nodes Identified
Description	To assess the effectiveness of intraoperative PINPOINT Near Infrared Fluorescence Imaging in the identification of lymph nodes in subjects with uterine and cervical malignancies who are undergoing lymph node mapping.
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

All analyses were completed using the number of lymph nodes identified.

Arm/Group Title	PINPOINT - Blue	Blue - PINPOINT
Arm/Group Description	The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes	The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
Measure Participants	82	81
Measure Confirmed Lymph Nodes	238	247
Number [Confirmed Lymph Nodes]	232	239

2. Secondary Outcome

Title	Effectiveness of PINPOINT and Blue Dye in the Identification of at Least One Lymph Node Defined as the Number of Subjects in Which at Least One Confirmed Lymph Node Was Identified With Either PINPOINT or Blue Dye
Description	To evaluate the effectiveness of PINPOINT and Blue dye in the identification of at least one lymph node (confirmed to be lymphoid tissue) per subject.
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment). Of the 176 subjects randomized who completed the study, 13 had significant protocol deviations. Thus, 163 subjects are included in the analysis population (81 subjects in the B-P arm and 82 subjects in the P-B arm).

Arm/Group Title	PINPOINT-Blue	Blue - PINPOINT
Arm/Group Description	The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes	The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
Measure Participants	82	81
IC2000 and PINPOINT	80	79
Isosulfan Blue	64	60

3. Secondary Outcome

Title	Effectiveness of PINPOINT and Blue Dye in the Identification of Bilateral Lymph Nodes Defined as the Number of Subjects in Which Lymph Nodes Were Identified Bilaterally With Either PINPOINT or Blue Dye.
Description	To evaluate the effectiveness of PINPOINT and Blue dye in the identification of bilateral lymph nodes (confirmed to be lymphoid tissue).
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment). Of the 176 subjects randomized who completed the study, 13 had significant protocol deviations. Thus, 163 subjects are included in the analysis population (81 subjects in the B-P arm and 82 subjects in the P-B arm).

Arm/Group Title	PINPOINT-Blue	Blue - PINPOINT
Arm/Group Description	The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes	The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
Measure Participants	82	81
IC2000 and PINPOINT	64	60
Isosulfan Blue	24	25

4. Secondary Outcome

Title	Identification of Lymph Nodes Following Lymphatic Channels Defined as the Number of Subjects in Which Confirmed Lymph Nodes Were Identified by Following a Lymphatic Channel With Either PINPOINT or Blue Dye.
Description	To determine the proportion of lymph nodes identified from following lymphatic channels
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment). Of the 176 subjects randomized who completed the study, 13 had significant protocol deviations. Thus, 163 subjects are included in the analysis population (81 subjects in the B-P arm and 82 subjects in the P-B arm).

Arm/Group Title	PINPOINT-Blue	Blue - PINPOINT
Arm/Group Description	The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes	The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
Measure Participants	82	81
IC2000 and PINPOINT	6	3
Isosulfan Blue	8	6

5. Secondary Outcome

Title	Safety of Interstitial Injection of ICG Defined as the Number of Adverse Effects Related to ICG
Description	To assess the safety of interstitial injection of ICG for intraoperative lymphatic mapping, as measured by number of subjects experiencing adverse effects related to the study treatment.
Time Frame	Day 0 to Day 30

Outcome Measure Data

Analysis Population Description

180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment). Of the 176 subjects randomized who completed the study, 13 had significant protocol deviations. Thus, 163 subjects are included in the analysis population (81 subjects in the B-P arm and 82 subjects in the P-B arm).

Arm/Group Title	PINPOINT-Blue	Blue - PINPOINT
Arm/Group Description	The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes	The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
Measure Participants	89	87
Number [Number of subjects]	0	0

6. Secondary Outcome

Title	Anatomic Distribution of Lymph Nodes
Description	To determine the anatomic distribution of lymph nodes
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment). Of the 176 subjects randomized who completed the study, 13 had significant protocol deviations. Thus, 163 subjects are included in the analysis population (81 subjects in the B-P arm and 82 subjects in the P-B arm).

Arm/Group Title	PINPOINT-Blue	Blue - PINPOINT
Arm/Group Description	The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes	The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
Measure Participants	82	81
Measure Lymph Nodes	232	239
Left obturator/internal iliac	28	36
Left external iliac	69	67
Left common iliac	11	6
Right obturator/internal iliac	39	45
Right external iliac	52	50
Right common iliac	17	18
Presacral	2	5
Para-aortic node below IMA	4	5
Other	10	7

Adverse Events

Time Frame	30 Days
Adverse Event Reporting Description	Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.
Arm/Group Title	Blue - PINPOINT		PINPOINT - Blue
Arm/Group Description	The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all 'ICG' nodes are identified or the investigator determines that 'ICG' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes		The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all 'ICG' nodes or determines that 'ICG' nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all 'blue' nodes are identified or the investigator determines that 'blue' nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised. PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
All Cause Mortality
	Blue - PINPOINT		PINPOINT - Blue
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/87 (0%)		0/89 (0%)
Serious Adverse Events
	Blue - PINPOINT		PINPOINT - Blue
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/87 (4.6%)		1/89 (1.1%)
Ear and labyrinth disorders
Vertigo	0/87 (0%)		1/89 (1.1%)
Gastrointestinal disorders
Partial bowel obstruction	1/87 (1.1%)		0/89 (0%)
Nervous system disorders
Dizziness	1/87 (1.1%)		0/89 (0%)
Respiratory, thoracic and mediastinal disorders
Atelectasis	1/87 (1.1%)		0/89 (0%)
Trace pleural effusions	1/87 (1.1%)		0/89 (0%)
Other (Not Including Serious) Adverse Events
	Blue - PINPOINT		PINPOINT - Blue
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/87 (14.9%)		10/89 (11.2%)
Gastrointestinal disorders
Nausea	7/87 (8%)		4/89 (4.5%)
Injury, poisoning and procedural complications
Procedural Pain	13/87 (14.9%)		10/89 (11.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.