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

Not Applicable

Completed

• Conditions: Primary Peritoneal; Ovarian Cancer; Fallopian Tube

• Registration Number: NCT01826227
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-04-01
• Study First Submitted QC: 2013-04-05
• Study First Posted: 2013-04-08
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Results First Submitted: 2017-09-07
• Results First Submitted QC: 2017-10-03
• Last Update Submitted: 2017-10-03
• Results First Posted: 2017-11-06
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States