NCT02045381

Brief Summary

Currently, appropriate patients undergo MRI imaging with immobilization and sequences optimized for diagnostic radiology purposes. Using a mutual information algorithm, these images are then registered to a treatment planning CT obtained with custom immobilization to minimize intra-and inter-treatment motion and positional variation. This image registration process is time-consuming and introduces additional layers of geometric uncertainty into what should be a highly precise treatment planning process. However, it is necessary, since radiation dose calculations cannot be performed on MRI data due to the lack of crucial density information. The investigator envisions CT-less treatment planning, using only MRI, due to superior imaging characteristics, fully integrated into the radiation oncology clinic. This study will begin this process.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 14, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2023

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

9.9 years

First QC Date

December 18, 2013

Last Update Submit

January 13, 2025

Conditions

Keywords

CancerMRI

Outcome Measures

Primary Outcomes (1)

  • Percentage of participants with MRI images suitable for analyses

    Patients will be off protocol immediately after the single MRI scan. Comparative treatment planning will occur off-line and will not be used for patient care.

    Day One

Study Arms (1)

MRI group

Patient receives one research MRI prior to radiation treatment.

Procedure: MRI Group

Interventions

MRI GroupPROCEDURE

A single research MRI

MRI group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants having a working diagnosis of malignancy in the liver, brain, head and neck, or pelvis, and a plan to treat with radiotherapy.

You may qualify if:

  • Patients ≥18 years of age
  • A working diagnosis of malignancy in the liver, brain, H\&N, or pelvis
  • A plan to treat with radiotherapy

You may not qualify if:

  • Patients with contraindications to having a contrast enhanced MRI scan. These contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the Radiology Department.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularBrain NeoplasmsHead and Neck NeoplasmsPelvic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Shruti Jolly, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2013

First Posted

January 24, 2014

Study Start

March 14, 2013

Primary Completion

February 9, 2023

Study Completion

February 9, 2023

Last Updated

January 14, 2025

Record last verified: 2025-01

Locations