Liver CancerNCT01210027
A Study of Radiation Toxicity in the Liver Using MRI-Based Perfusion
An observational study of Liver Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to 1 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have one of the following: primary hepatocellular cancer, hepatobiliary cancer, or metastatic disease to the liver.
Who may be able to join
- 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.
Who cannot join
- Women who are pregnant or breastfeeding are excluded.
- Prisoners are excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: A Pilot Study of Radiation Toxicity in the Liver Using MRI-Based Perfusion
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.
- Conditions
- Liver Cancer
- Medical subject headings
- Liver Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Liver Function Before, During and After Radiation
The primary objective of this research is to assess how a course of radiation therapy changes the way blood flows through the liver. Researchers want to use the information collected from this research for future research, to see if this change in blood flow indicates that an individual patient is at higher risk for complications from the radiation therapy, specifically Radiation-Induced Liver Disease (RILD). To be able to do this, the researchers will be using MRI (magnetic resonance imaging) scans completed before, during, and after radiation therapy.
Measured: 2-3 months for treatment; indefinite for follow-up
Secondary outcomes (2)
Measure of Liver Perfusion
Develop a model to predict post-treatment liver perfusion based on pre-treatment perfusion, intratreatment perfusion, and radiation dose.
Measured: Follow-up - Approximately 7 Years
Association Between Liver Perfusion and Changes in Tumor and Clinical Outcomes
Explore the association between liver perfusion changes in tumor and clinical outcomes, including the size of tumor; local tumor progression; distant metastases; overall survival; and toxicity (radiation-induced liver disease).
Measured: Follow-up - Approximately 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study startMar 2007
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Theodore Lawrence, MD, PhD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210027
- Sponsor's protocol ID
- UMCC 2006.067
- Other IDs
- HUM 5910
- Status last verified
- Dec 2024
- First submitted
- 2 Sep 2010
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Radiation Toxicity in the Liver Using MRI-Based Perfusion
- ClinicalTrials.gov ID
- NCT01210027
- Acronym / sponsor ID
- UMCC 2006.067
- Conditions
- Liver Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Mar 2007 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 28 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have one of the following: primary hepatocellular cancer, hepatobiliary cancer, or metastatic disease to the liver.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Women who are pregnant or breastfeeding are excluded.
- Prisoners are excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure of Liver Function Before, During and After Radiation
Time frame: 2-3 months for treatment; indefinite for follow-up
The primary objective of this research is to assess how a course of radiation therapy changes the way blood flows through the liver. Researchers want to use the information collected from this research for future research, to see if this change in blood flow indicates that an individual patient is at higher risk for complications from the radiation therapy, specifically Radiation-Induced Liver Disease (RILD). To be able to do this, the researchers will be using MRI (magnetic resonance imaging) scans completed before, during, and after radiation therapy.
2 secondary outcomes
Measure of Liver Perfusion
Time frame: Follow-up - Approximately 7 Years
Association Between Liver Perfusion and Changes in Tumor and Clinical Outcomes
Time frame: Follow-up - Approximately 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodore Lawrence, MD, PhD principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of Liver Function Before, During and After Radiation (time frame: 2-3 months for treatment; indefinite for follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.