Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-24 @ 10:08 PM
NCT ID:
NCT00816335
Brief Summary:
The purpose of this pilot study is to evaluate a combined and integrated technological approach of 18F-FDG-directed perioperative PET/CT imaging and intraoperative handheld gamma probe detection of known and occult disease in patients undergoing surgery for solid malignancies.
Detailed Description:
OBJECTIVES:
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.
Study:
NCT00816335
Study Brief:
Protocol Section:
NCT00816335