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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


Phase 0
18 Years
N/A
Open (Enrolling)
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Determine perioperative PET/CT imaging combined with intraoperative use of handheld gamma probe is feasible during surgical procedure to resect malignancy.

Outcome Time Frame:

up to five years

Safety Issue:

Yes

Principal Investigator

Stephen P. Povoski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

OSU-08031

NCT ID:

NCT00816335

Start Date:

October 2008

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific

Name

Location

Ohio State University Medical CenterColumbus, Ohio  43210