This trial is active, not recruiting.

Conditions ovarian cancer, fallopian tube, primary peritoneal
Treatments positron emission tomography, 18f-fluoro-2-deoxy-d-lucose, cytoreductive surgery
Sponsor Memorial Sloan Kettering Cancer Center
Start date March 2013
End date March 2017
Trial size 5 participants
Trial identifier NCT01826227, 13-017


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
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
cytoreductive surgery

Primary Outcomes

sensitivity and specificity
time frame: 2 years

Eligibility Criteria

Female participants at least 19 years old.

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

Additional Information

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
Principal investigator Dennis Chi, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.