Multi-parametric Magnetic Resonance Imaging for Prostate Cancer Patients

September 21, 2023 updated by: Stephen Brown, Henry Ford Health System

Pilot Study of Using Multi-parametric Magnetic Resonance Imaging for Organ Delineation and Tumor Response Assessment of Prostate Cancer Patients Being Treated With Radiation Therapy

This is a pilot study of implement multi-parametric MR imaging for organ delineation and tumor response assessment of prostate cancer patients being treated with radiation therapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The study aims to generate intraprostatic lesions maps based on imaging, perform the treatment planning to compute the highest feasible simultaneous boosting dose to intraprostatic lesion and characterize longitudinal changes in imaging characteristics.

Study Type

Interventional

Enrollment (Actual)

9

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

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Histologically confirmed prostate adenocarcinoma

Exclusion Criteria:

  • Patients with metal fragments or implanted devices such as pacemakers and aneurysm clips are not eligible for the study considering

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multi-parametric MRI for Prostate Cancer
MRI will be acquired for prostate cancer patients undergoing radiation treatment.
Device: Multiparametric MRI
MRI will be acquired before, during and after radiation treatment to evaluate treatment response

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of Imaging Biomarkers to Localize the Intraprostatic Lesions and Predict Radiation Treatment Response
Time Frame: 2 years
Identify the radiomics features selected from multimodal MRI to distinguish the dominant lesions from the normal tissues within the prostate. Track the changes of these features with longitudinal MRI scans to identify its correlation with the local control.
2 years
Tumor Response
Time Frame: 2 years
Tumor response as measured by an increase in PSA.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

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 (Actual)

October 4, 2017

Primary Completion (Actual)

February 15, 2022

Study Completion (Actual)

February 15, 2022

Study Registration Dates

First Submitted

June 5, 2017

First Submitted That Met QC Criteria

June 6, 2017

First Posted (Actual)

June 8, 2017

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prostate Imaging 10911

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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