Hepatocellular CarcinomaNCT01519232
A Study of Changes in Hepatic Function During Radiation Therapy Using Hepatobiliary Single Photon Emission Tomography (SPECT)
An observational study of Hepatocellular Carcinoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
Radiation-induced liver disease (RILD) is a syndrome characterized by the development of anicteric ascites approximately 2 weeks to 4 months after hepatic irradiation. Previous studies have shown that both the volume of liver irradiated and the dose of radiation delivered are prominent factors for development of RILD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Liver Irradiation
- Type of treatment
- Surgery or procedure
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to May 2014
- 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: cancer patients undergoing radiation of the Liver
Who may be able to join
- cancer patients undergoing radiation of the Liver
- women and men who agree to avoid pregnancy
- life expectancy of at least 6 months
Who cannot join
- pregnant women
- breatsfeeding women
- prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-5010
About this study
Official title: A Pilot Study of Changes in Hepatic Function During Radiation Therapy Using Hepatobiliary SPECT
Radiation-induced liver disease (RILD) is a syndrome characterized by the development of anicteric ascites approximately 2 weeks to 4 months after hepatic irradiation. Previous studies have shown that both the volume of liver irradiated and the dose of radiation delivered are prominent factors for development of RILD. While use of a population-based normal tissue complication probability model allows investigators to limit the risk of RILD to a clinically acceptable level, a test that permits investigators to determine an individual's risk of RILD during the course of treatment may allow for individualized treatment modifications, either to prevent toxicity or increase efficacy.
Read the detailed description
Early, but subclinical physiologic changes in the liver may be associated with the future development of RILD. There are currently limited data on how a local change in hepatic function associates with regional radiation dose, and how the change of hepatic function during and after radiation therapy (RT) associates with RILD. In the present study, a radiological methodology that is minimally invasive will be used to measure volumetric hepatic functions in patients with intrahepatic malignancies before, during, and after a course of fractioned radiation therapy.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Liver Irradiation
- Keywords
- hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver IrradiationRadiation
Patients already scheduled to undergo radiation treatment
| Study group | Role | What they receive |
|---|---|---|
| Liver Irradiation | patients already scheduled to undergo liver irradiation Receives: Radiation: Liver Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in hepatobiliary single photon emission tomography (SPECT) after radiation therapy
Changes in SPECT, which reflect hepatocyte function, will be correlated with specific regions of radiation dose to determine a relationship between dose and radiation-induced damage.
Measured: 6 months
Secondary outcomes (1)
measuring values between regional radiation dose and local hepatic function as measured by hepatobiliary SPECT, in normal liver parenchyma
dynamic hepatobiliary single photon emission tomography (SPECT) values will assess changes in hepatocyte function in patients with intrahepatic malignancies receiving radiation therapy. Perhaps a relationship between SPECT and dosage can be determined.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startAug 2008
- Primary completionJun 2012
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Feng, MD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519232
- Sponsor's protocol ID
- UMCC 2007-110
- Other IDs
- HUM00015656
- Status last verified
- May 2015
- First submitted
- 23 Sep 2011
- Last updated
- 18 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Changes in Hepatic Function During Radiation Therapy Using Hepatobiliary SPECT
- ClinicalTrials.gov ID
- NCT01519232
- Acronym / sponsor ID
- UMCC 2007-110
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 26 Jan 2012 (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.
Radiation-induced liver disease (RILD) is a syndrome characterized by the development of anicteric ascites approximately 2 weeks to 4 months after hepatic irradiation. Previous studies have shown that both the volume of liver irradiated and the dose of radiation delivered are prominent factors for development of RILD. While use of a population-based normal tissue complication probability model allows investigators to limit the risk of RILD to a clinically acceptable level, a test that permits investigators to determine an individual's risk of RILD during the course of treatment may allow for individualized treatment modifications, either to prevent toxicity or increase efficacy.
Detailed description
Early, but subclinical physiologic changes in the liver may be associated with the future development of RILD. There are currently limited data on how a local change in hepatic function associates with regional radiation dose, and how the change of hepatic function during and after radiation therapy (RT) associates with RILD. In the present study, a radiological methodology that is minimally invasive will be used to measure volumetric hepatic functions in patients with intrahepatic malignancies before, during, and after a course of fractioned radiation therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver Irradiation | – | Radiation: Liver Irradiationpatients already scheduled to undergo liver irradiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cancer patients undergoing radiation of the Liver
Key inclusion criteria (3 listed)
- cancer patients undergoing radiation of the Liver
- women and men who agree to avoid pregnancy
- life expectancy of at least 6 months
Key exclusion criteria (3 listed)
- pregnant women
- breatsfeeding women
- prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver IrradiationPatients already scheduled to undergo radiation treatment | Radiation | Liver Irradiation |
Primary outcome
Changes in hepatobiliary single photon emission tomography (SPECT) after radiation therapy
Time frame: 6 months
Changes in SPECT, which reflect hepatocyte function, will be correlated with specific regions of radiation dose to determine a relationship between dose and radiation-induced damage.
1 secondary outcome
measuring values between regional radiation dose and local hepatic function as measured by hepatobiliary SPECT, in normal liver parenchyma
Time frame: 6 months
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 18 May 2015.
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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.
Mary Feng, MD 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 Hepatocellular Carcinoma, 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 3 inclusion and 3 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 18 May 2015. 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?
Changes in hepatobiliary single photon emission tomography (SPECT) after radiation therapy (time frame: 6 months). 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 18 May 2015.