NCT03180398

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

October 4, 2017

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

October 12, 2023

Completed
Last Updated

October 12, 2023

Status Verified

September 1, 2023

Enrollment Period

4.4 years

First QC Date

June 5, 2017

Results QC Date

March 20, 2023

Last Update Submit

September 21, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Detection of Imaging Biomarkers to Localize the Intraprostatic Lesions and Predict Radiation Treatment Response

    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

    Tumor response as measured by an increase in PSA.

    2 years

Study Arms (1)

Multi-parametric MRI for Prostate Cancer

EXPERIMENTAL

MRI will be acquired for prostate cancer patients undergoing radiation treatment.

Device: Multiparametric MRI

Interventions

MRI will be acquired before, during and after radiation treatment to evaluate treatment response

Multi-parametric MRI for Prostate Cancer

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed prostate adenocarcinoma

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance ImagingTomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Results Point of Contact

Title
Dr. Stephen Brown
Organization
Henry Ford Health

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Radiobiology Research Laboratories

Study Record Dates

First Submitted

June 5, 2017

First Posted

June 8, 2017

Study Start

October 4, 2017

Primary Completion

February 15, 2022

Study Completion

February 15, 2022

Last Updated

October 12, 2023

Results First Posted

October 12, 2023

Record last verified: 2023-09

Locations