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

Study Overview
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Brief Summary
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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.

Official Title
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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: A Pilot Study

Conditions
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Ovarian Cancer, Fallopian Tube, Primary Peritoneal

Intervention / Treatment
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* Procedure: Positron Emission Tomography
* Radiation: 18F-Fluoro-2-deoxy-D-lucose
* Procedure: Cytoreductive surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positron Emission Tomography<br>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. | Procedure: Positron Emission Tomography<br> <br> Radiation: 18F-Fluoro-2-deoxy-D-lucose<br> <br> Procedure: Cytoreductive surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | 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 | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET (Positron Emission Tomography), 18F-FDG, Cytoreductive Surgery, 13-017