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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02045381
Other study ID # UMCC 2012.113
Secondary ID HUM00068061
Status Recruiting
Phase
First received
Last updated
Start date March 14, 2013
Est. completion date October 2024

Study information

Verified date April 2024
Source University of Michigan Rogel Cancer Center
Contact Shruti Jolly, MD
Phone 734-936-4300
Email shrutij@umich.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 432
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients =18 years of age - A working diagnosis of malignancy in the liver, brain, H&N, or pelvis - A plan to treat with radiotherapy Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
MRI Group
A single research MRI

Locations

Country Name City State
United States Univeristy of Michigan Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan Rogel Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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