Clinical trial NCT00816335: Fludeoxyglucose F 18 PET/CT Imaging in Finding Cancer in Patients Undergoing Surgery for Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2009-01-01
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Determine perioperative PET/CT imaging combined with intraoperative use of handheld gamma probe is feasible during surgical procedure to resect malignancy.
timeFrame: up to five years
Secondary outcomes:
measure: Evaluate if perioperative PET/CT imaging can assist in intraoperatively localizing tumor and verify resection of disease.
timeFrame: up to five years
measure: Evaluate intraoperative detection of tumor sites using a handheld gamma probe after preoperative injection of 18F-FDG combined with preoperative PET/CT imaging.
timeFrame: up to five years
measure: Evaluate specimen PET/CT imaging using the preoperative 18F-FDG dose for detecting presence of tumor within the specimen and for assessing surgical margins.
timeFrame: up to five years
measure: Evaluate specimen MRI imaging for detecting presence of tumor within remnant tissue of appropriately selected resected specimens and for assessing surgical margins.
timeFrame: up to five years
measure: 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.
timeFrame: up to five years
measure: 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.
timeFrame: up to five years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Stephen P. Povoski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Povoski SP, Chapman GJ, Murrey DA Jr, Lee R, Martin EW Jr, Hall NC. Intraoperative detection of (1)(8)F-FDG-avid tissue sites using the increased probe counting efficiency of the K-alpha probe design and variance-based statistical analysis with the three-sigma criteria. BMC Cancer. 2013 Mar 4;13:98. doi: 10.1186/1471-2407-13-98.