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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

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ClinicalTrials.gov Identifier: NCT01826227
Recruitment Status : Completed
First Posted : April 8, 2013
Results First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Primary Peritoneal Procedure: Positron Emission Tomography Radiation: 18F-Fluoro-2-deoxy-D-lucose Procedure: Cytoreductive surgery Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : March 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Procedure: Positron Emission Tomography
Radiation: 18F-Fluoro-2-deoxy-D-lucose
Procedure: Cytoreductive surgery


Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity [ Time Frame: 2 years ]
    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


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826227


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Dennis Chi, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01826227    
Other Study ID Numbers: 13-017
First Posted: April 8, 2013    Key Record Dates
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017
Last Verified: December 2016
Keywords provided by Memorial Sloan Kettering Cancer Center:
PET (Positron Emission Tomography)
18F-FDG
Cytoreductive Surgery
13-017