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

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ClinicalTrials.gov Identifier: NCT01826227
Recruitment Status : Completed
First Posted : April 8, 2013
Results First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Ovarian Cancer
Fallopian Tube
Primary Peritoneal
Interventions Procedure: Positron Emission Tomography
Radiation: 18F-Fluoro-2-deoxy-D-lucose
Procedure: Cytoreductive surgery
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Positron Emission Tomography
Hide 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
Arm/Group Title Positron Emission Tomography
Hide 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 Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants
62
(44 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
5
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
5
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
  20.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
4
  80.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
 100.0%
1.Primary Outcome
Title Sensitivity
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not available because the PET probe failed.
Arm/Group Title Positron Emission Tomography
Hide 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 Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
NA [1] 
[1]
Data not available because the PET probe failed.
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Positron Emission Tomography
Hide 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 (%)
Total   0/5 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Positron Emission Tomography
Affected / at Risk (%)
Total   1/5 (20.00%) 
Cardiac disorders   
Supraventricular tachycardia   1/5 (20.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Positron Emission Tomography
Affected / at Risk (%)
Total   5/5 (100.00%) 
Blood and lymphatic system disorders   
Anemia   5/5 (100.00%) 
Investigations   
Alanine aminotransferase increased   3/5 (60.00%) 
Aspartate aminotransferase increased   3/5 (60.00%) 
Blood bilirubin increased   2/5 (40.00%) 
Lymphocyte count decreased   2/5 (40.00%) 
Platelet count decreased   2/5 (40.00%) 
Activated partial thromboplastin time prolonged   1/5 (20.00%) 
INR increased   1/5 (20.00%) 
White blood cell decreased   1/5 (20.00%) 
Metabolism and nutrition disorders   
Hyperglycemia   5/5 (100.00%) 
Hypoalbuminemia   5/5 (100.00%) 
Hypocalcemia   5/5 (100.00%) 
Hypophosphatemia   3/5 (60.00%) 
Hypomagnesemia   2/5 (40.00%) 
Hyponatremia   2/5 (40.00%) 
Hyperkalemia   1/5 (20.00%) 
Hypermagnesemia   1/5 (20.00%) 
Hypoglycemia   1/5 (20.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dennis Chi, MD
Organization: Memorial Sloan Kettering Cancer Center
Phone: 212-639-5016
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01826227     History of Changes
Other Study ID Numbers: 13-017
First Submitted: April 1, 2013
First Posted: April 8, 2013
Results First Submitted: September 7, 2017
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017