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11C-acetate for Treatment Response After Radiotherapy for HCC

Primary Purpose

Hepatocellular Carcinoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
11C-Acetate
Sponsored by
Justin Sims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Indiana University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Radiotherapy treatment monitoring of hepatocellular carcinoma

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 11, 2015
Last Updated
October 25, 2017
Sponsor
Justin Sims
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1. Study Identification

Unique Protocol Identification Number
NCT02549755
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment
Study Start Date
September 2015 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Justin Sims

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy treatment monitoring of hepatocellular carcinoma
Arm Type
Other
Arm 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.
Intervention Type
Drug
Intervention Name(s)
11C-Acetate
Intervention Description
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
Primary Outcome Measure Information:
Title
To Compare Changes in 11C-acetate Uptake at One and Three Months Following Radiotherapy With Pre-treatment Uptake of 11C-acetate
Description
The single patient enrolled in the trial showed no uptake in the liver tumor on the pretreatment scan and was dropped from the trial.
Time Frame
At three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin B Sims, MD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

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11C-acetate for Treatment Response After Radiotherapy for HCC

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