11C-acetate for Treatment Response After Radiotherapy for HCC

Justin Sims

Status and phase: Terminated; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: 11C-Acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT02549755

IUSCC-0543

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Radiotherapy treatment monitoring of hepatocellular carcinoma

Other group

Description:

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.

Treatment:

Drug: 11C-Acetate