Novel PET/CT Agents and MRS/MRI in Prostate CA and High Risk Prostate Cancer: An Inter-SPORE Collaboration

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00987376
First received: December 20, 2007
Last updated: August 20, 2014
Last verified: August 2014

December 20, 2007
August 20, 2014
November 2003
September 2009   (final data collection date for primary outcome measure)
Test accuracy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00987376 on ClinicalTrials.gov Archive Site
Test comparative accuracy of PET and MRI [ Time Frame: 2years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Novel PET/CT Agents and MRS/MRI in Prostate CA and High Risk Prostate Cancer: An Inter-SPORE Collaboration
Comparison of Novel PET/CT Imaging Agents and MRS/MRI in Metastatic and High Risk Prostate Cancer: An Inter-SPORE Collaboration

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.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Prostate Cancer
Device: Diagnostic Imaging: C11 choline PET; C11 acetate PET; and MRI Spectroscopy
C11 Choline, C11 Acetate PET and MRI
Experimental: 1
Prostate cancer patients
Intervention: Device: Diagnostic Imaging: C11 choline PET; C11 acetate PET; and MRI Spectroscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00987376
8-03, CA91956-02
Yes
Val J. Lowe, Mayo Clinic
Mayo Clinic
National Cancer Institute (NCI)
Not Provided
Mayo Clinic
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP