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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01826227
• Other study ID #: 13-017
• Status: Completed
• Phase: N/A
• First received: April 1, 2013
• Last updated: October 3, 2017
• Start date: March 2013
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fallopian Tube
• Ovarian Cancer
• Primary Peritoneal

Intervention

Procedure:
• Positron Emission Tomography

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

Procedure:
• Cytoreductive surgery

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center