- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002981
PET Scan in Treating Patients With Metastatic Prostate Cancer
11C-Methionine and 2-18F-Fluoro-2-Deoxy-D-Glucose PET Imaging in Patients With Progressive Prostate Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Measure the pharmacokinetics, whole body retention of isotope, and biodistribution of C11-methionine and FDG by PET imaging and serial sampling of blood in men with progressive prostate cancer.
- Explore metabolism of each PET scan by comparing the sensitivity of C11-methionine or FDG by PET scanning in androgen independent prostate cancer metastases with the sensitivity of C11-methionine or FDG in androgen dependent metastases on a site by site basis.
- Compare C11-methionine and FDG PET scanning to standard of care diagnostic studies which include the Tc 99m bone scan, computed tomography, and magnetic resonance imaging.
Patients fast for 6 hours prior to PET imaging with the exception of liberal water intake which is encouraged. A two way catheter is placed in the urinary bladder, and continuous isotonic saline irrigation is performed throughout scan acquisition to reduce the interference in imaging lesions in the pelvic lymph nodes and adjacent pelvic bones caused by radiation excreted in urine held in the bladder.
Each patient receives C11-methionine intravenously. PET imaging begins immediately after injection for approximately 60 minutes total using standard imaging procedures. Immediately following the completion of imaging after C11-methionine administration, each patient receives FDG intravenously. PET imaging begins approximately 45 minutes thereafter for approximately 60 minutes using standard imaging procedures.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
DISEASE CHARACTERISTICS:
- Histologically confirmed prostate adenocarcinoma
- Must have an at least 50% increase in PSA which is sustained for a minimum of 3 observations obtained at least 1 week apart
- Must have development of new lesions on bone scintigraphy or greater than 50% increase in measurable disease on CT or MRI scan
- Metastatic disease
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Karnofsky greater than 60%
Hematopoietic:
- ANC greater than 1,000/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Not specified
Renal:
- Not specified
Cardiovascular:
- No clinically significant cardiac disease
Pulmonary:
- No clinically significant pulmonary disease
Other:
- No active infection not controlled by antibiotics
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Study Plan
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: PET Scan
Each patient receives C11-methionine intravenously.
PET imaging begins immediately after injection for approximately 60 minutes total using standard imaging procedures.
Immediately following the completion of imaging after C11-methionine administration, each patient receives FDG intravenously.
PET imaging begins approximately 45 minutes thereafter for approximately 60 minutes using standard imaging procedures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics
Time Frame: 3 years
|
3 years
|
Metabolism
Time Frame: 3 years
|
3 years
|
Comparison of the sensitivity of PET imaging with FDG with standard of care diagnostic methods
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Steven M. Larson, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 97-007
- P30CA008748 (U.S. NIH Grant/Contract)
- MSKCC-97007
- NCI-G97-1232
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.
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