11C-acetate for Treatment Response After Radiotherapy for HCC
NCT ID: NCT02549755
Last Updated: 2017-11-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
1 participants
INTERVENTIONAL
2015-09-30
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Radiotherapy treatment monitoring of hepatocellular carcinoma
All patients enrolled in the trial will undergo 3 PET/CT studies using 11C-acetate at the injected radiotracer. The patients will be imaged prior to their radiation therapy and at 1 and 3 months following the completion of their radiation therapy. They will also undergo an MRI scan of the liver at each of those time points.
11C-Acetate
The 11C-Acetate radiopharmaceutical will be administered intravenously at a dose of 20-40 mCi (0.74-1.5 GBq).
There will be a total of three 11C-acetate radiopharmaceutical administrations for each patient
Interventions
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11C-Acetate
The 11C-Acetate radiopharmaceutical will be administered intravenously at a dose of 20-40 mCi (0.74-1.5 GBq).
There will be a total of three 11C-acetate radiopharmaceutical administrations for each patient
Eligibility Criteria
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Inclusion Criteria
* Subject is willing to participate in the study and has signed the study informed consent
* Subject is available and willing to comply with the protocol evaluations
* Diagnosed hepatocellular carcinoma confined to a single lobe of the liver if undergoing 90Y radioembolization
* Diagnosed hepatocellular carcinoma confined to the liver if undergoing Stereotactic Body Radiation Therapy (SBRT)
* Under consideration for 90Y radioembolization or Stereotactic Body Radiation Therapy (SBRT)
Exclusion Criteria
* GFR \< 45
* Life expectancy \< 6 months
* Claustrophobic and cannot tolerate imaging procedures
* Weigh \> 350 lb (upper weight limit of scanner beds)
* Special vulnerabilities (e.g. fetuses, neonatales, pregnant women, children, prisoners, institutionalized individuals).
18 Years
ALL
No
Sponsors
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Justin Sims
OTHER
Responsible Party
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Justin Sims
Assistant Professor of Clinical Radiology
Principal Investigators
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Justin B Sims, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
Locations
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Indiana University
Indianapolis, Indiana, United States
Countries
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References
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Other Identifiers
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IUSCC-0543
Identifier Type: -
Identifier Source: org_study_id