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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01826227
First received: April 1, 2013
Last updated: May 9, 2014
Last verified: May 2014

April 1, 2013
May 9, 2014
March 2013
March 2015   (final data collection date for primary outcome measure)
sensitivity and specificity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01826227 on ClinicalTrials.gov Archive Site
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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
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

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.

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Interventional
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Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Ovarian Cancer
  • Fallopian Tube
  • Primary Peritoneal
  • Procedure: Positron Emission Tomography
  • Radiation: 18F-Fluoro-2-deoxy-D-lucose
  • Procedure: Cytoreductive surgery
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.
Interventions:
  • Procedure: Positron Emission Tomography
  • Radiation: 18F-Fluoro-2-deoxy-D-lucose
  • Procedure: Cytoreductive surgery
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
March 2015
March 2015   (final data collection date for primary outcome measure)

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
Female
19 Years and older
No
Contact: Dennis Chi, MD 212-639-5016
Contact: Neeta Pandit-Taskar, MD 212-639-3046
United States
 
NCT01826227
13-017
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Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Dennis Chi, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP