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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Primary Peritoneal; Fallopian Tube; Ovarian Cancer

Treatments: Procedure: Cytoreductive surgery; Radiation: 18F-Fluoro-2-deoxy-D-lucose; Procedure: Positron Emission Tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT01826227

13-017

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Positron Emission Tomography

Experimental group

Description:

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.

Treatment:

Procedure: Cytoreductive surgery

Radiation: 18F-Fluoro-2-deoxy-D-lucose

Procedure: Positron Emission Tomography