11C-acetate for Treatment Response After Radiotherapy for HCC

October 25, 2017 updated by: Justin Sims

Feasibility of 11C-acetate in the Monitoring of Treatment Response Following Radiotherapy in Patients With Hepatocellular Carcinoma

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To Compare Changes in 11C-acetate Uptake at One and Three Months Following Radiotherapy With Pre-treatment Uptake of 11C-acetate
Time Frame: 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.
At three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Justin Sims

Investigators

  • Principal Investigator: Justin B Sims, MD, Indiana University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

September 11, 2015

First Submitted That Met QC Criteria

September 14, 2015

First Posted (Estimate)

September 15, 2015

Study Record Updates

Last Update Posted (Actual)

November 22, 2017

Last Update Submitted That Met QC Criteria

October 25, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUSCC-0543

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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