Multi-parametric Magnetic Resonance Imaging for Prostate Cancer Patients

Sponsor

Henry Ford Health System (Other)

Overall Status

Terminated

CT.gov ID

NCT03180398

Collaborator

(none)

Enrollment

Location

Arm

52.4

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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. 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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Device: Multiparametric MRI	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 4, 2017

Actual Primary Completion Date :

Feb 15, 2022

Actual Study Completion Date :

Feb 15, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Detection of imaging biomarkers to localize the intraprostatic lesions and predict radiation treatment response [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Henry Ford Health System	Detroit	Michigan	United States	48202

Sponsors and Collaborators

Henry Ford Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stephen Brown, Director, Radiobiology Research Laboratories, Henry Ford Health System

ClinicalTrials.gov Identifier:

NCT03180398

Other Study ID Numbers:

Prostate Imaging 10911

First Posted:

Jun 8, 2017

Last Update Posted:

Mar 3, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Mar 3, 2022