Pilot Study Evaluating a Combined and Integrated Technological Approach of F-18-FDG-Directed Perioperative PET/CT Imaging and Intraoperative Handheld Gamma Prove Detection of Known and Occult Disease in Patients Undergoing Surgery for Solid Malignancies
1. To determine if the perioperative PET/CT imaging (consisting of preoperative PET/CT
imaging, specimen PET/CT imaging, and postoperative PET/CT imaging) combined with
intraoperative use of the handheld gamma probe is feasible during a surgical procedure
to resect malignancy.
2. To evaluate if perioperative PET/CT imaging can assist in intraoperatively localizing
tumor and verify complete resection of disease.
3. To evaluate intraoperative detection of tumor sites using a handheld gamma probe after
preoperative injection of 18F-FDG combined with preoperative PET/CT imaging.
4. To evaluate specimen PET/CT imaging using the preoperative 18F-FDG dose for detecting
presence of tumor within the specimen and for assessing surgical margins.
5. To evaluate specimen MRI imaging for detecting presence of tumor within remnant tissue
of appropriately selected resected specimens and for assessing surgical margins.
6. To evaluate standard pathology sampling with image guided pathology sampling (using
specimen PET/CT imaging) in order to determine if sensitivity and accuracy of
pathologic evaluation may be improved with PET/CT image guidance.
7. To compare activity of surgical specimen samples in a well counter and correlate
activity with pathologic findings and tumor burden in order to determine if the
concepts in the previous two specific aims can be utilized to benefit patients treated
at centers without access to PET/CT imaging equipment.
OUTLINE: Patients undergo pre- and postoperative fludeoxyglucose F 18 (^18FDG) PET/CT
imaging. An intraoperative handheld gamma probe is used to detect ^18FDG-avid tissues.
Resected specimens are assessed by ^18FDG PET imaging for intraoperative verification of
complete tumor resection.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Determine perioperative PET/CT imaging combined with intraoperative use of handheld gamma probe is feasible during surgical procedure to resect malignancy.
up to five years
Stephen P. Povoski, MD
Ohio State University Comprehensive Cancer Center
United States: Institutional Review Board
|Ohio State University Medical Center||Columbus, Ohio 43210|