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MRI-guided Bone Marrow Biopsies of Prostate Cancer Patients

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.
 
ClinicalTrials.gov Identifier: NCT00165386
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : December 9, 2009
Sponsor:
Information provided by:
Dana-Farber Cancer Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Magnetic Resonance Imaging Procedure: Bone Marrow Biopsy Not Applicable

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".

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: MRI-guided Bone Marrow Biopsies of Advanced CaP Patients
Study Start Date : July 2001
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.)

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 ClinicalTrials.gov identifier (NCT number): NCT00165386


Locations
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United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Mary-Ellen Taplin, MD Dana-Farber Cancer Institute
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ClinicalTrials.gov Identifier: NCT00165386    
Other Study ID Numbers: 01-108
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: December 9, 2009
Last Verified: December 2009
Keywords provided by Dana-Farber Cancer Institute:
MRI-guided bone marrow biopsy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases