Status:
ACTIVE_NOT_RECRUITING
Characterization of Prostate Cancer With 3T MR
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
40+ years
Brief Summary
The long-term goal of this proposal is to provide a pre-treatment evaluation that can assist in the rational selection of patients to undergo appropriate and definitive therapy for prostate cancer. In...
Detailed Description
In our laboratory we have combined the use of new 3T clinical magnetic resonance (MR) technology, dynamic-contrast enhancement (DCE), and a unique endorectal-coil (ERC) probe in order to non-invasivel...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Biopsy-proven adenocarcinoma of the prostate.
- Written documentation from the urologist stating the anticipation that the patient will undergo radical prostatectomy or biopsy of the prostate within six months of MRI.
- The interval between biopsy and protocol MRI must not be less than 2 weeks.
- Pathologic specimens from radical prostatectomy must be provided for whole mount analysis.
- Patients will sign a study-specific consent prior to study entry.
- Men above the age of 40 years old
- Exclusion Criteria
- Patients who because of age, general medical or psychiatric condition, or physiologic status unrelated to the presence of prostate cancer cannot give valid informed consent.
- Patients unwilling or unable to undergo MRI including patients with contra-indications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips.
- Patients who cannot tolerate or have contra-indications to ERC insertion; for example, patients who have had a prior abdominoperineal resection of the rectum or have Crohn's disease.
- Patients with an allergic reaction to latex.
- Cryosurgery, surgery for prostate cancer including TURP, prostatic radiotherapy, including bradiotherapy for rectal cancer, androgen deprivation therapy, rectal surgery, or alternative medicine prior to radical prostatectomy.
- Any metallic implant (e.g. hip) or device that might distort local magnetic field and compromise quality of MRI.
- Radical prostatectomy or biopsy of the prostate not planned to be performed within six (6) months of protocol MRI.
- Patients who have undergone BCG for bladder cancer.
- Patients with severe motion artifacts rendering the data unusable.
- Patients who have an allergic history to gadopentetate dimeglumine administration.
- Patients with a contraindication to the administration of glucagon (pheochromocytoma, islet pancreatic tumor, or insulin-dependent diabetes) or a prior history of allergic reaction following glucagon administration.
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2025
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT00831142
Start Date
June 1 2006
End Date
May 31 2025
Last Update
April 26 2024
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215