Fludeoxyglucose F 18 PET/CT Imaging in Finding Cancer in Patients Undergoing Surgery for Solid Tumors

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

PROCEDURE

PET/CT scan

For all patients undergoing a preoperative PET/CT scan on the day of surgery, at approximately 70 minutes post-injection of 18F-FDG, a diagnostic whole body PET/CT scan will be obtained on a Siemens Biograph 16 PET/CT scanner (Siemens, Knoxville, TN).

DRUG

18F-FDG Injection

Patients undergoing a preoperative PET/CT scan the day of surgery, are required to have fasted for at least 4 hours prior to the anticipated preoperative PET/CT scan. Patients participating in this pilot study (whether they have had their preoperative PET/CT scan prior to the day of surgery or whether they are having their preoperative PET/CT scan on the day of surgery) will receive a preoperative IV injection into a peripheral vein of 15 mCi of 18FFDG at time interval of approximately 60 to 180 minutes prior to anticipated time of surgery.

PROCEDURE

Preoperative 18F-FDG PET/CT Scan

Patients undergoing preoperative PET/CT scan day of surgery, at approximately 70 minutes post-injection of 18F-FDG, a diagnostic whole body PET/CT scan will be obtained. PET imaging will immediately be preceded by noncontrast transmission CT (for attenuation correction and anatomic correlation purposes) and will be obtained from the base of the skull to the mid thighs. Bed positions will be scanned for 3 minutes each, moving the patient through the scanner in a craniocaudal direction. Once the preoperative PET/CT scan is acquired, images will be reviewed by the nuclear medicine physician and the surgeon.

DRUG

18F-FDG for patients with Bladder Cancer

Elimination of 18F-FDG by the urinary system and accumulation in the bladder impacts the differentiation between residual 18F-FDG in the bladder and activity in tumor and adjacent lymph nodes. For patients with bladder cancer, the urinary catheter routinely placed in the operating room will be inserted in the Ambulatory Surgery Unit (ASU) by the urologist on-service or the urology research nurse. A 3-way Foley catheter will be placed for continuous bladder irrigation with Normal Saline (0.9%) initiated in ASU and will continue for the duration of the imaging procedure at a standard rate of 10cc/minute. The urology research nurse will transport the patient to and from the PET/CT area and monitor the continuous bladder irrigation during the imaging session.

PROCEDURE

Surgical Procedure

Previously determined operative procedure based on type of solid malignancy. Factors include extent and location of disease, physiologic status of patient intraoperatively, any technical considerations influenced by anatomic constraints, and a risk: benefit analysis of proposed procedure. The decision to proceed with resection on these factors, and will constantly re-evaluate during resection to ensure patient well-being, both short and long term, is foremost consideration. Evaluation of extent of disease during surgical exploration will include inspection and palpation of entire area being evaluated. Tissue that is highly suspicious for involvement with metastatic disease that alters the surgical decision making plan of resection will be biopsied or resected for histologic confirmation if feasible and safe. If patient is found to have resectable disease, deemed safe patient, surgeon will continue and proceed with definitive surgical resection with assistance of handheld gamma probe.

PROCEDURE

Specimen PET/CT Scan

Resected surgical specimen will be placed on top of paraffin block. Digital photos of the specimen will be obtained for visual correlation of specimen placement on paraffin block. Two bed position 10 minute specimen PET/CT scan will be performed on surgical specimen. If remnant tissue is available, a second image maybe acquired via MRI. Images will be processed and reviewed for quality and presence or absence of hypermetabolic foci and correlated with anatomical information provided by CT and MRI imaging that were originally noted in the preoperative clinical PET/CT scan. During the time when the excised surgical specimens are transported to radiology for specimen PET/CT scanning, additional evaluation of these ex-vivo specimens with other tumor detection devices may be undertaken. Specimen will then be transported back to the operating room in order to be sent to and processed by surgical pathology for standard pathologic evaluation.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Stephen P. Povoski, MD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-10-31

Primary Completion

2011-08-31

Completion

2011-08-31

Countries

• United States

Study Locations