- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00816335
Fludeoxyglucose F 18 PET/CT Imaging in Finding Cancer in Patients Undergoing Surgery for Solid Tumors
March 31, 2016 updated by: Stephen Povoski, Ohio State University Comprehensive Cancer Center
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
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.
Study Overview
Status
Completed
Detailed Description
OBJECTIVES:
- 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.
- To evaluate if perioperative PET/CT imaging can assist in intraoperatively localizing tumor and verify complete resection of disease.
- To evaluate intraoperative detection of tumor sites using a handheld gamma probe after preoperative injection of 18F-FDG combined with preoperative PET/CT imaging.
- 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.
- To evaluate specimen MRI imaging for detecting presence of tumor within remnant tissue of appropriately selected resected specimens and for assessing surgical margins.
- 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.
- 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.
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210-1240
- Ohio State University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
F-FDG-directed surgery for known or suspected malignancy using gamma detection probes.
|
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).
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine perioperative PET/CT imaging combined with intraoperative use of handheld gamma probe is feasible during surgical procedure to resect malignancy.
Time Frame: up to five years
|
up to five years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate if perioperative PET/CT imaging can assist in intraoperatively localizing tumor and verify resection of disease.
Time Frame: up to five years
|
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.
Time Frame: up to five years
|
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.
Time Frame: up to five years
|
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.
Time Frame: up to five years
|
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.
Time Frame: up to five years
|
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.
Time Frame: up to five years
|
up to five years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stephen P. Povoski, MD, Ohio State University Comprehensive Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
December 31, 2008
First Submitted That Met QC Criteria
December 31, 2008
First Posted (Estimate)
January 1, 2009
Study Record Updates
Last Update Posted (Estimate)
April 4, 2016
Last Update Submitted That Met QC Criteria
March 31, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSU-08031
- NCI-2012-00958 (Registry Identifier: Clinical Trials Reporting Program (CTRP))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Unspecified Adult Solid Tumor, Protocol Specific
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)RecruitingCollection and Storage of Tissue Samples From Patients Undergoing Surgery For Suspected Solid TumorsUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Kantonsspital GraubuendenUnknownUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificSwitzerland
-
National Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Vanderbilt UniversityNational Cancer Institute (NCI)TerminatedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
University of ChicagoNational Cancer Institute (NCI)CompletedSirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed By SurgeryUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)WithdrawnUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol Specific
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyWithdrawnUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol Specific | Hematopoietic/Lymphoid CancerUnited States
-
University of Texas Southwestern Medical CenterRecruitingUnspecified Adult Solid Tumor, Protocol SpecificUnited States
Clinical Trials on PET/CT scan
-
University of UtahNational Cancer Institute (NCI)CompletedFluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) in Cancer Associated VenothromboembolismVenothromboembolismUnited States
-
HALO DiagnosticsCompletedProstate CancerUnited States
-
Radboud University Medical CenterUnknownCarcinoma, Non Small Cell LungNetherlands
-
Guy's and St Thomas' NHS Foundation TrustKing's College LondonRecruiting
-
Colchester General HospitalAnglia Ruskin UniversityUnknownRectal NeoplasmsUnited Kingdom
-
Ontario Clinical Oncology Group (OCOG)Ontario Ministry of Health and Long Term CareCompletedLymphoma | Breast Cancer | Head and Neck Cancer | Esophageal Cancer | Ovarian Cancer | Non-small Cell Lung CancerCanada
-
GE HealthcareLaboratory Corporation of AmericaNot yet recruiting
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)CompletedNon-Hodgkin's Lymphoma | Lung CancerUnited States
-
University of ArizonaBlue Earth Diagnostics; Banner University Medical CenterCompletedProstate AdenocarcinomaUnited States
-
Radboud University Medical CenterABX advanced biochemical compounds GmbH; Radboud Translational MedicineRecruitingProstate Cancer RecurrentNetherlands