11C-acetate for Treatment Response After Radiotherapy for HCC

Phase 2

Terminated

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: 11C-Acetate

• Registration Number: NCT02549755
• Lead Sponsor: Justin Sims

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-11
• Study First Submitted QC: 2015-09-14
• Study First Posted: 2015-09-15
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-10
• Results First Submitted: 2017-10-25
• Results First Submitted QC: 2017-10-25
• Last Update Submitted: 2017-10-25
• Results First Posted: 2017-11-22
• Last Update Posted: 2017-11-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiotherapy treatment monitoring of hepatocellular carcinoma	11C-Acetate	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.

Primary Outcome Measures

Name	Time	Method
To Compare Changes in 11C-acetate Uptake at One and Three Months Following Radiotherapy With Pre-treatment Uptake of 11C-acetate	At three months	The single patient enrolled in the trial showed no uptake in the liver tumor on the pretreatment scan and was dropped from the trial.

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States