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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ovarian Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Sensitivity
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Sensitivity
Time Frame: 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