Fludeoxyglucose F 18 PET/CT Imaging in Finding Cancer in Patients Undergoing Surgery for Solid Tumors
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Procedure: PET/CT scanProcedure: Preoperative 18F-FDG PET/CT ScanProcedure: Surgical ProcedureProcedure: Specimen PET/CT Scan
- Registration Number
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
- Patients must be 18 years of age or older.
- Patients must either have a histologic-confirmed solid malignancy or have a suspected solid malignancy which has required a diagnostic preoperative PET/CT scan or for which a diagnostic preoperative PET/CT scan has been recommended
- Patients must clinically have been determined to be a candidate for the indicated surgical procedure.
- Patients may have had prior surgery and/or chemotherapy with no limit to the number of prior therapeutic procedures or chemotherapeutic regimens.
- Patients must have a performance status of 0, 1 or 2 by ECOG standards.
- Patients must give written informed consent, including consent to have IV line placed for 18F-FDG administration.
- Females of childbearing age must have a negative pregnancy test (by Beta HCG qualitative analysis), must have had a history of a surgical sterilization, or must give history of no menses in past twelve months.
- Fasting blood sugar less than 200 mg/dl.
- Any patient with active CNS tumor involvement.
- Any patient who is pregnant or lactating.
- Any patient with a body size and habitus that is determined to prohibit use of the diagnostic equipment.
- Any patient with a tumor burden that is determined to be so great (as determined by preoperative PET/CT scanning or intraoperative findings) that further surgery is not advised.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 18F-FDG Injection F-FDG-directed surgery for known or suspected malignancy using gamma detection probes. Arm 1 18F-FDG for patients with Bladder Cancer F-FDG-directed surgery for known or suspected malignancy using gamma detection probes. Arm 1 PET/CT scan F-FDG-directed surgery for known or suspected malignancy using gamma detection probes. Arm 1 Specimen PET/CT Scan F-FDG-directed surgery for known or suspected malignancy using gamma detection probes. Arm 1 Surgical Procedure F-FDG-directed surgery for known or suspected malignancy using gamma detection probes. Arm 1 Preoperative 18F-FDG PET/CT Scan F-FDG-directed surgery for known or suspected malignancy using gamma detection probes.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Evaluate if perioperative PET/CT imaging can assist in intraoperatively localizing tumor and verify resection of disease. up to five years Evaluate intraoperative detection of tumor sites using a handheld gamma probe after preoperative injection of 18F-FDG combined with preoperative PET/CT imaging. up to five years Evaluate specimen PET/CT imaging using the preoperative 18F-FDG dose for detecting presence of tumor within the specimen and for assessing surgical margins. up to five years Evaluate specimen MRI imaging for detecting presence of tumor within remnant tissue of appropriately selected resected specimens and for assessing surgical margins. up to five years 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. up to five years Compare activity of surgical specimen samples with pathologic findings and tumor burden in order to determine if the concepts in previous two specific aims can be utilized to benefit patients treated at centers without access to PET/CT imaging equipment. up to five years
Trial Locations
- Locations (1)
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States