Clinical trial NCT02549755: 11C-acetate for Treatment Response After Radiotherapy for HCC
Official title: Feasibility of 11C-acetate in the Monitoring of Treatment Response Following Radiotherapy in Patients With Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2015-09-15
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: It is thought that PET of the abdomen with 11C Acetate will provide new information regarding whether or not patient's have benefited from radiotherapy. To test this theory, the project will evaluate the potential of 11C acetate to serve as an earlier and/or better signal of treatment success.


Eligibility criteria: Inclusion Criteria:

* \> 18 years of age
* 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:

* Pregnant or planning to become pregnant within the next 12 months or breast-feeding
* 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).

Primary outcomes:
measure: To Compare Changes in 11C-acetate Uptake at One and Three Months Following Radiotherapy With Pre-treatment Uptake of 11C-acetate
timeFrame: At three months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Justin B Sims, MD
role: PRINCIPAL_INVESTIGATOR
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