Novel PET/CT Agents and MRS/MRI in Prostate CA and High Risk Prostate Cancer: An Inter-SPORE Collaboration
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Purpose
Prostate cancer imaging using traditional anatomic modalities including CT, MR, and ultrasound is limited. Improvement in current imaging modalities or development of new ones should be a priority in prostate cancer research. Optimal treatment varies considerably for patients with different staging characterizations and new imaging methods that more accurately stage patients could lead to more appropriate treatment. The objective of this study is to obtain preliminary, comparative data on new, promising imaging methods for prostate cancer. PET/CT imaging using 11C-choline,11C-acetate, and Y86 or 18F-Adenosylcobalamin and MRI spectroscopy (MRS) of prostate cancer will be compared. Direct comparison of these imaging methods has never been done and Mayo Clinic and Johns Hopkins are uniquely able to conduct such a trial as an inter-SPORE collaboration.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Device: Diagnostic Imaging: C11 choline PET; C11 acetate PET; and MRI Spectroscopy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Comparison of Novel PET/CT Imaging Agents and MRS/MRI in Metastatic and High Risk Prostate Cancer: An Inter-SPORE Collaboration |
- Test accuracy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Test comparative accuracy of PET and MRI [ Time Frame: 2years ] [ Designated as safety issue: No ]
| Enrollment: | 8 |
| Study Start Date: | November 2003 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Prostate cancer patients
|
Device: Diagnostic Imaging: C11 choline PET; C11 acetate PET; and MRI Spectroscopy
C11 Choline, C11 Acetate PET and MRI
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males 18 years of age or older
- Patients who have completed staging CT and/or bone scan as part of their routine workup
- Patients with bulky metastatic prostate cancer who have 5 or more lesions suspicious for distant metastases as determined by routine CT and/or bone scans that are untreated by radiation
Exclusion Criteria:
- Patients who are less than 6 weeks post operative for Greenfield filter placement
- Patients with metallic surgical implants including pacemaker implants, cochlear implants, dentures held in place by magnets imbedded in the gums and aneurysm clips except those inserted at Mayo and only those inserted after October of 1994 and /or metal fragments in the body including metal fragments in the eyes
Contacts and Locations More Information
No publications provided
| Responsible Party: | Val J. Lowe, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00987376 History of Changes |
| Other Study ID Numbers: | 8-03, CA91956-02 |
| Study First Received: | December 20, 2007 |
| Last Updated: | July 27, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Choline Lipotropic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Gastrointestinal Agents Therapeutic Uses Lipid Regulating Agents Nootropic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013