TMVP1-ICG Mapping in Laparoscopic SLN Detection in Cervical Cancer

Sponsor

Huazhong University of Science and Technology (Other)

Overall Status

Unknown status

CT.gov ID

NCT03320772

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Sentinel lymph node (SLN) mapping is an acceptable surgical strategy determine whether to perform radical lymphadenectomy in patients with early-stage cervical cancer. Investigators aim to determine the validity of this technique with our novel tumor targeted fluorescent TMVP1-ICG to increased accuracy of SLN mapping.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Drug: TMVP1-ICG Drug: ICG	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Novel Tumor Targeted Fluorescent TMTP1-ICG Mapping in Laparoscopic Sentinel Lymph Node Detection in Cervical Cancer Patients

Actual Study Start Date :

May 1, 2017

Anticipated Primary Completion Date :

May 1, 2018

Anticipated Study Completion Date :

May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TMVP1 The TMVP1-ICG (WuXi AppTec, Shanghai, China) powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. 0.4ml of TMVP1-ICG solution was injected into the cervix, divided into 3 and 9 o'clock position, in the operating room. During the laparoscopy, the PinPoint S1 Novadaq (PinPoint Endoscopic Fluorescence Imaging System, NOVADAQ, Mississauga, ON, Canada), 30° laparoscopes were used for fluorescent detection.	Drug: TMVP1-ICG Detection of SLN
Active Comparator: ICG The ICG powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. 0.4ml of this ICG solution was injected into the cervix, divided into 3 and 9 o'clock position, in the operating room. During the laparoscopy, the PinPoint S1 Novadaq (PinPoint Endoscopic Fluorescence Imaging System, NOVADAQ, Mississauga, ON, Canada), 30° laparoscopes were used for fluorescent detection.	Drug: ICG Detection of SLN

Arm

Intervention/Treatment

Experimental: TMVP1

The TMVP1-ICG (WuXi AppTec, Shanghai, China) powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. 0.4ml of TMVP1-ICG solution was injected into the cervix, divided into 3 and 9 o'clock position, in the operating room. During the laparoscopy, the PinPoint S1 Novadaq (PinPoint Endoscopic Fluorescence Imaging System, NOVADAQ, Mississauga, ON, Canada), 30° laparoscopes were used for fluorescent detection.

Drug: TMVP1-ICG

Detection of SLN

Active Comparator: ICG

The ICG powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. 0.4ml of this ICG solution was injected into the cervix, divided into 3 and 9 o'clock position, in the operating room. During the laparoscopy, the PinPoint S1 Novadaq (PinPoint Endoscopic Fluorescence Imaging System, NOVADAQ, Mississauga, ON, Canada), 30° laparoscopes were used for fluorescent detection.

Drug: ICG

Detection of SLN

Outcome Measures

Primary Outcome Measures

Detection rate of sentinel lymph node [1 day]
Detection of sentinel lymph node per patient

Secondary Outcome Measures

Sensitivity [7 days]
Sensitivity of SLN mapping of TMVP1-ICG compared to the sensitivity of SLN mapping of ICG
Specificity [7 days]
Specificity of SLN mapping of TMVP1-ICG compared to the sensitivity of SLN mapping of ICG
Incidence of adverse events [7 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

At least 18 years of age, married, without childbearing requirements at the time of consent.
FIGO stage IA1-IIB cervical squamous cell cancer and is a candidate for laparoscopy intervention, with lymph node dissection being a part of the surgical plan.
Subject has provided written informed consent.

Exclusion Criteria:

Breast-feeding or pregnant
Ongoing participation in another clinical trial with an investigational drug with 3 months
Own allergy towards ICG and/or alcohol
Diagnosis of bacterial vaginosis, fungal vaginitis, sexually transmitted diseases
Patients with cardiac dysfunction or hepatic insufficiency or renal insufficiency

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tongji Hospital, Tongji Medical Colledge, HUST	Wuhan	Hubei	China	430030

Sponsors and Collaborators

Huazhong University of Science and Technology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ding Ma, Director, Huazhong University of Science and Technology

ClinicalTrials.gov Identifier:

NCT03320772

Other Study ID Numbers:

TMVP1-ICG-01

First Posted:

Oct 25, 2017

Last Update Posted:

Oct 25, 2017

Last Verified:

Oct 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Uterine Cervical Neoplasms

Study Results

No Results Posted as of Oct 25, 2017