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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00987376
Recruitment Status : Completed
First Posted : September 30, 2009
Last Update Posted : January 13, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Val Lowe, Mayo Clinic

Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Device: Diagnostic Imaging: C11 choline PET; C11 acetate PET; and MRI Spectroscopy Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2003
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Prostate cancer patients
Device: Diagnostic Imaging: C11 choline PET; C11 acetate PET; and MRI Spectroscopy
C11 Choline, C11 Acetate PET and MRI

Primary Outcome Measures :
  1. Test accuracy [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Test comparative accuracy of PET and MRI [ Time Frame: 2years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00987376

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United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)

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Responsible Party: Val Lowe, Val J. Lowe, MD, Mayo Clinic Identifier: NCT00987376     History of Changes
Other Study ID Numbers: 8-03
First Posted: September 30, 2009    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Diseases, Male
Lipotropic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents