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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

NCT ID: NCT01826227

Last Updated: 2017-11-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-12-31

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.

Detailed Description

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Conditions

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Ovarian Cancer Fallopian Tube Primary Peritoneal

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Positron Emission Tomography

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.

Group Type EXPERIMENTAL

Positron Emission Tomography

Intervention Type PROCEDURE

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

Intervention Type RADIATION

Cytoreductive surgery

Intervention Type PROCEDURE

Interventions

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Positron Emission Tomography

Intervention Type PROCEDURE

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

Intervention Type RADIATION

Cytoreductive surgery

Intervention Type PROCEDURE

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
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dennis Chi, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

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13-017

Identifier Type: -

Identifier Source: org_study_id