Status:
COMPLETED
Fludeoxyglucose F 18 PET/CT Imaging in Finding Cancer in Patients Undergoing Surgery for Solid Tumors
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 kn...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00816335
Start Date
October 1 2008
End Date
August 1 2011
Last Update
April 4 2016
Active Locations (1)
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1
Ohio State University Medical Center
Columbus, Ohio, United States, 43210-1240