- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00165386
MRI-guided Bone Marrow Biopsies of Prostate Cancer Patients
December 7, 2009 updated by: Dana-Farber Cancer Institute
MRI-guided Bone Marrow Biopsies of Advanced CaP Patients
The purpose of this study is to target lesions of the prostate in the bone and to biopsy these lesions using MRI to identify the areas.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- This study involves a one-time, MRI-guided bone marrow biopsy. Prior to this procedure, patients will need to have a bone scan performed within the last three months and a PSA blood test drawn within one month of registration to the study.
- Patients are also required to participate in the DFCI research study "Collection of Specimens and Clinical Data for Patients with Prostate Cancer or at High Risk for Prostate Cancer".
Study Type
Interventional
Enrollment
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Histologic diagnosis of prostate cancer
- Bone scan consistent with or suspicious of metastatic prostate cancer within last three months
- Platelet count > 50,000/ul
- PT and aPTT < 1.5 x control
- At least one week removed from taking aspirin or coumadin
- Currently participating in protocol "Collection of Specimens and Clinical Data for Patients with Prostate Cancer or at High Risk for Prostate Cancer"
Exclusion Criteria:
- Devices incompatible to MR studies (e.g. pacemakers, ear implants, etc.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To compare the yield of detecting metastatic prostate cancer tissue using MRI-guided bone marrow needle biopsies to that of historical controls obtained through unguided biopsies.
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Secondary Outcome Measures
Outcome Measure |
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To evaluate the sensitivity of radiographic bone marrow changes detected by MRI for prostate cancer, as determined by the pathologic findings from bone marrow biopsy.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2001
Primary Completion (Actual)
January 1, 2006
Study Completion (Actual)
January 1, 2006
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (Estimate)
September 14, 2005
Study Record Updates
Last Update Posted (Estimate)
December 9, 2009
Last Update Submitted That Met QC Criteria
December 7, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01-108
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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