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MRI for Assessing Prostate Cancer Response (NA_00067284)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2015 by Sidney Kimmel Comprehensive Cancer Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01607008
First Posted: May 28, 2012
Last Update Posted: November 20, 2015
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.
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
  Purpose

Prostate cancer is one of most common cancers in America, affecting 1 in 6 men. External beam radiation therapy is one of the common methods to treat prostate cancer. Although radiotherapy is effective, side effects to the adjacent normal organs limit the therapeutic ratio. Those side effects are usually associated with the radiation damage of the normal tissue surrounding prostate, e.g. bladder, urethra and rectum etc. Both effectiveness and the side effects of radiation treatment are often accessed after whole course of radiotherapy, which makes the early intervention difficult. The current research project is a feasibility study of utilizing advanced magnetic resonance imaging (MRI) techniques to access radiotherapy treatment response of prostate cancer during and right after radiotherapy.

Many advanced MRI techniques, e.g. spectroscopy (MRS), diffusion-weighted (DWI), dynamic contrast enhanced (DCE) perfusion weighted images, have been used in radiology departments for diagnostic purpose. This research project is to study the feasibility of using advanced MRI sequences to monitor tissue response during and after radiotherapy. The tissue changes revealed from MRI can provide physicians early information on possible tumor recurrence and normal tissue toxicity, therefore, the early intervention may be possible to spare normal tissue and cure the patient. The project is designed to combine several different advanced MRI imaging techniques systematically to study tissue changes during radiotherapy, which has not been seen elsewhere to date.

Another important goal of this research project is to study the feasibility of associating functional MRI with radiation treatment dose distribution. Tissue response during radiation treatment depends on dose. The functional MRI can provide more information than simple anatomic information. Mapping the functional MRI spatially and associating them with 3D dose distribution in radiation treatment planning system is one important step to quantitative assess the relationship between radiation treatment and tissue changes due to the radiation.


Condition Intervention
Prostate Cancer Other: MRI imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multiparametric MRI for Assessing Radiotherapy Treatment Response of Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • MRI use to predict treatment response [ Time Frame: 2 months ]

    To study the feasibility of using magnetic resonance imaging (MRI) to predict treatment response in patients with prostate cancer undergoing radiation therapy. The anatomical, functional, and location changes in tumor or normal tissues during the radiation will be assessed and correlated with MRI data and treatment dose.

    Hypothesis one: Functional or anatomical MRI signal changes during the radiotherapy can be used as predictors to assess treatment response. We anticipate observing dose dependent MRI signal changes during the radiation treatment.



Secondary Outcome Measures:
  • Evaluating MRI use to predict functional radiation treatment dose distribution [ Time Frame: 2 months ]

    Secondary objective: A secondary objective is evaluating the feasibility of associating functional MRI images with radiation treatment dose distribution. Both tumor control probability and normal tissue complication probability are related to the dose received by patient during the radiotherapy.

    Hypothesis two: With carefull data processing, resampling and registration, the functional MRI data can be imported into radiation treatment planning system. Quantitative analysis to assess tissue changes during radiotherapy and its correlation with radiation dose treatment can be performed.



Estimated Enrollment: 20
Study Start Date: September 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
MRI imaging
Use of MRI imaging in conjunction with standard radiation treatment
Other: MRI imaging

3 total MRI imaging studies:

  1. pre standard radiation treatment
  2. during standard radiation treatment
  3. post standard radiation treatment

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically-confirmed prostate cancer
  • Plan to undergo external radiation treatment of prostate cancer

Exclusion Criteria:

  • Patients who cannot undergo an MRIs
  • Patients who are allergic to gadolinium based contrast agent
  • Patients who have cardiac pacemaker or other electronic or metal implant
  • Patients who have chronic kidney disease
  Contacts and Locations
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): NCT01607008


Contacts
Contact: Danny Song, M.D. 410-502-5875 dsong2@jhmi.edu
Contact: Shirl DiPasquale, R.N. 410-614-1598 sdipasq1@jhmi.edu

Locations
United States, Maryland
The Sidney Kimmel Comprehsensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Sub-Investigator: Theodore DeWeese, M.D.         
Sub-Investigator: John Wong, Ph.D.         
Sub-Investigator: Yi Ye, M.D.         
Sub-Investigator: Phuoc Tran, M.D.         
Sub-Investigator: Katarzyna Macura, M.D.         
Sub-Investigator: Micahel Jacobs, M.D.         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Danny Song, M.D. The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  More Information

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01607008     History of Changes
Other Study ID Numbers: J11143
NA_00067284 ( Other Identifier: Johns Hopkins Institutional Review Boards )
First Submitted: May 24, 2012
First Posted: May 28, 2012
Last Update Posted: November 20, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases