Intraoperative Detection of Lesions Using PET (Positron Emission Tomography) Probe During Secondary Cytoreductive Surgery for Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancer
This trial has been completed.
|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||December 2016|
|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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
sensitivity and specificity
time frame: 2 years
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
|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|
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