Intraoperative Detection of Lesions Using PET (Positron Emission Tomography) Probe During Secondary Cytoreductive Surgery for Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancer

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01826227
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arm: 1
• Duration (Months): 45
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to see if Positron Emission Tomography (PET) probes make it easier for your surgeon to find cancer and remove it during your surgery. A PET probe is a wandlike device that can detect radioactivity.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer; Fallopian Tube; Primary Peritoneal	Procedure: Positron Emission Tomography; Radiation: 18F-Fluoro-2-deoxy-D-lucose; Procedure: Cytoreductive surgery	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Intraoperative Detection of Lesions Using PET (Positron Emission Tomography) Probe During Secondary Cytoreductive Surgery for Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancer: A Pilot Study
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Positron Emission Tomography This is a pilot study to determine the ability of intraoperative PET probe to detect and localize recurrent disease. Patients with evidence for a first recurrence of ovarian, fallopian tube or primary peritoneal carcinoma, with evidence of 18F-FDG avid disease on 18F-FDG PET/CT and who are able to undergo secondary CRS are eligible. 20 patients will be studied. All patients will undergo secondary cytoreduction guided by intraoperative PET probe survey. Intraoperative count levels as well as exvivo counts of the resected specimens will be done. Specimens detected with probe only will be labeled so and will be submitted to pathology for histopathologic confirmation.

Procedure: Positron Emission Tomography; Radiation: 18F-Fluoro-2-deoxy-D-lucose; Procedure: Cytoreductive surgery

Outcome Measures

Primary Outcome Measures

1. Sensitivity [2 years]

   of detection of lesions with PET probes compared to preoperative FDG18F-FDG PET and standard intraoperative examination. Sensitivity is defined as the percent of lesions that were found with malignant disease divided by the number of lesions with true presence of malignant disease based on the pathology report. A higher sensitivity will indicate a higher number of lesions found with the respective technique thus providing an initial estimate of the incremental benefit of the PET probe as opposed to the other techniques

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Pathologically proven diagnosis of ovarian carcinoma, fallopian tube, or primary peritoneal not to include tumors of low malignant potential (all stage, grade, and histology)

• First recurrence

• Platinum sensitive as defined by disease free interval ≥ 6 months

• Radiological evidence of recurrent disease on preoperative PET/diagnostic CT

• Planned surgical secondary cytoreduction via laparotomy

• 18 years old

Exclusion Criteria:

• Secondary cytoreduction via laparoscopy or robotically assisted laparoscopy

• Tumors of low malignant potential

• Beyond first recurrence

• With the exception of non-melanoma skin cancer, subjects with other invasive malignancies, who had (or have) any evidence of the other cancer present within the last 5 years, are excluded

• Active infection requiring parenteral antibiotics

• For subjects with diabetes mellitus, a blood sugar will be checked preoperatively and must be <200 for participation in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065

Sponsors and Collaborators

• Memorial Sloan Kettering Cancer Center

Investigators

• Principal Investigator: Dennis Chi, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Memorial Sloan Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT01826227
• Other Study ID Numbers: 13-017
• First Posted: Apr 8, 2013
• Last Update Posted: Nov 6, 2017
• Last Verified: Dec 1, 2016

• Keywords provided by Memorial Sloan Kettering Cancer Center: PET (Positron Emission Tomography); 18F-FDG; Cytoreductive Surgery; 13-017

Study Results

Participant Flow

Arm/Group Title	Positron Emission Tomography
Arm/Group Description	This is a pilot study to determine the ability of intraoperative PET probe to detect and localize recurrent disease. Patients with evidence for a first recurrence of ovarian, fallopian tube or primary peritoneal carcinoma, with evidence of 18F-FDG avid disease on 18F-FDG PET/CT and who are able to undergo secondary CRS are eligible. 20 patients will be studied. All patients will undergo secondary cytoreduction guided by intraoperative PET probe survey. Intraoperative count levels as well as exvivo counts of the resected specimens will be done. Specimens detected with probe only will be labeled so and will be submitted to pathology for histopathologic confirmation. Positron Emission Tomography 18F-Fluoro-2-deoxy-D-lucose Cytoreductive surgery
Period Title: Overall Study
STARTED	5
COMPLETED	5
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Positron Emission Tomography
Arm/Group Description	This is a pilot study to determine the ability of intraoperative PET probe to detect and localize recurrent disease. Patients with evidence for a first recurrence of ovarian, fallopian tube or primary peritoneal carcinoma, with evidence of 18F-FDG avid disease on 18F-FDG PET/CT and who are able to undergo secondary CRS are eligible. 20 patients will be studied. All patients will undergo secondary cytoreduction guided by intraoperative PET probe survey. Intraoperative count levels as well as exvivo counts of the resected specimens will be done. Specimens detected with probe only will be labeled so and will be submitted to pathology for histopathologic confirmation. Positron Emission Tomography 18F-Fluoro-2-deoxy-D-lucose Cytoreductive surgery
Overall Participants	5
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	62
Sex: Female, Male (Count of Participants)
Female	5 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	5 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 20%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	4 80%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	5 100%

Outcome Measures

1. Primary Outcome

Title	Sensitivity
Description	of detection of lesions with PET probes compared to preoperative FDG18F-FDG PET and standard intraoperative examination. Sensitivity is defined as the percent of lesions that were found with malignant disease divided by the number of lesions with true presence of malignant disease based on the pathology report. A higher sensitivity will indicate a higher number of lesions found with the respective technique thus providing an initial estimate of the incremental benefit of the PET probe as opposed to the other techniques
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Data not available because the PET probe failed.

Arm/Group Title	Positron Emission Tomography
Arm/Group Description	This is a pilot study to determine the ability of intraoperative PET probe to detect and localize recurrent disease. Patients with evidence for a first recurrence of ovarian, fallopian tube or primary peritoneal carcinoma, with evidence of 18F-FDG avid disease on 18F-FDG PET/CT and who are able to undergo secondary CRS are eligible. 20 patients will be studied. All patients will undergo secondary cytoreduction guided by intraoperative PET probe survey. Intraoperative count levels as well as exvivo counts of the resected specimens will be done. Specimens detected with probe only will be labeled so and will be submitted to pathology for histopathologic confirmation. Positron Emission Tomography 18F-Fluoro-2-deoxy-D-lucose Cytoreductive surgery
Measure Participants	5
Count of Participants [Participants]	NA NaN

Adverse Events

Time Frame	1 year
Arm/Group Title	Positron Emission Tomography
Arm/Group Description	This is a pilot study to determine the ability of intraoperative PET probe to detect and localize recurrent disease. Patients with evidence for a first recurrence of ovarian, fallopian tube or primary peritoneal carcinoma, with evidence of 18F-FDG avid disease on 18F-FDG PET/CT and who are able to undergo secondary CRS are eligible. 20 patients will be studied. All patients will undergo secondary cytoreduction guided by intraoperative PET probe survey. Intraoperative count levels as well as exvivo counts of the resected specimens will be done. Specimens detected with probe only will be labeled so and will be submitted to pathology for histopathologic confirmation. Positron Emission Tomography 18F-Fluoro-2-deoxy-D-lucose Cytoreductive surgery
All Cause Mortality
	Positron Emission Tomography
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Serious Adverse Events
	Positron Emission Tomography
	Affected / at Risk (%)	# Events
Total	1/5 (20%)
Cardiac disorders
Supraventricular tachycardia	1/5 (20%)
Other (Not Including Serious) Adverse Events
	Positron Emission Tomography
	Affected / at Risk (%)	# Events
Total	5/5 (100%)
Blood and lymphatic system disorders
Anemia	5/5 (100%)
Investigations
Alanine aminotransferase increased	3/5 (60%)
Aspartate aminotransferase increased	3/5 (60%)
Blood bilirubin increased	2/5 (40%)
Lymphocyte count decreased	2/5 (40%)
Platelet count decreased	2/5 (40%)
Activated partial thromboplastin time prolonged	1/5 (20%)
INR increased	1/5 (20%)
White blood cell decreased	1/5 (20%)
Metabolism and nutrition disorders
Hyperglycemia	5/5 (100%)
Hypoalbuminemia	5/5 (100%)
Hypocalcemia	5/5 (100%)
Hypophosphatemia	3/5 (60%)
Hypomagnesemia	2/5 (40%)
Hyponatremia	2/5 (40%)
Hyperkalemia	1/5 (20%)
Hypermagnesemia	1/5 (20%)
Hypoglycemia	1/5 (20%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.