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A Study of Radiation Toxicity in the Liver Using MRI-Based Perfusion

NCT ID: NCT01210027

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

143 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Study Completion Date

2023-04-01

Brief Summary

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Researchers at the the University of Michigan are conducting a research project to assess how a course of radiation therapy changes the way blood flows through the liver. To be able to do this, the researchers will be using MRI (magnetic resonance imaging) scans completed before, during, and after radiation therapy. MRI's will be done on 4 or 5 occasions. On each occasion, you will be injected with a fluid called gadolinium (a contrast agent) before getting an MRI. This contrast agent makes it easier for the Researchers to see your organs in the scans, and causes any abnormal areas to become very bright on the MRI. This agent will be injected into a vein in your arm or leg. Each MRI scan will last approximately 45 minutes.

Detailed Description

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Conditions

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Liver Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients must be ≥18 years of age.
* The patient's planned cancer management is radiation to the liver with or without chemotherapy.
* Patients must have a performance status of 0-2 and a life expectancy of at least 3 months.
* Patients should have no contraindications to having a contrast enhanced MRI scan.

Exclusion Criteria

* Women who are pregnant or breastfeeding are excluded.
* Prisoners are excluded
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan Rogel Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Theodore Lawrence, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

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University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM 5910

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2006.067

Identifier Type: -

Identifier Source: org_study_id