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

NCT01826227 | Completed Results

• 1 other identifier: 13-017
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer; Fallopian Tube; Primary Peritoneal

Keywords

PET (Positron Emission Tomography); 18F-FDG; Cytoreductive Surgery; 13-017

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Positron Emission Tomography

EXPERIMENTAL

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; Radiation: 18F-Fluoro-2-deoxy-D-lucose; Procedure: Cytoreductive surgery

Interventions

Positron Emission Tomography PROCEDURE

Positron Emission Tomography

18F-Fluoro-2-deoxy-D-lucose RADIATION

Positron Emission Tomography

Cytoreductive surgery PROCEDURE

Positron Emission Tomography

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Magnetic Resonance Spectroscopy; Cytoreduction Surgical Procedures

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Dennis Chi, MD
• Organization: Memorial Sloan Kettering Cancer Center

chid@mskcc.org

212-639-5016

Study Officials

• Dennis Chi, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 8, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 6, 2017
• Results First Posted: November 6, 2017

Record last verified: 2016-12

Locations

US (1)