11C-acetate for Treatment Response After Radiotherapy for HCC

NCT02549755 | Terminated Phase 2 Results DMC

• 1 other identifier: IUSCC-0543
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  At three months

Study Arms (1)

Radiotherapy treatment monitoring of hepatocellular carcinoma

OTHER

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

Interventions

11C-Acetate DRUG

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

Radiotherapy treatment monitoring of hepatocellular carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Justin Sims: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (27)

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MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

carbon-11 acetate

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Justin Sims, M.D.
• Organization: Indiana University School of Medicine

simsjb@iupui.edu

317 948-6340

Study Officials

• Justin B Sims, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Clinical Radiology

Study Record Dates

• First Submitted: September 11, 2015
• First Posted: September 15, 2015
• Study Start: September 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 22, 2017
• Results First Posted: November 22, 2017

Record last verified: 2017-10

Locations

US (1)