11C-acetate for Treatment Response After Radiotherapy for HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02549755
• Other study ID #: IUSCC-0543
• Status: Terminated
• Phase: Phase 2
• First received: September 11, 2015
• Last updated: October 25, 2017
• Start date: September 2015
• Est. completion date: October 2016

Study information

• Verified date: October 2017
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Justin Sims

Country where clinical trial is conducted

United States, 

References & Publications (27)

Andolino DL, Johnson CS, Maluccio M, Kwo P, Tector AJ, Zook J, Johnstone PA, Cardenes HR. Stereotactic body radiotherapy for primary hepatocellular carcinoma. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e447-53. doi: 10.1016/j.ijrobp.2011.04.011. Epub 2011 Jun 7. — View Citation

Cheung TT, Ho CL, Lo CM, Chen S, Chan SC, Chok KS, Fung JY, Yan Chan AC, Sharr W, Yau T, Poon RT, Fan ST. 11C-acetate and 18F-FDG PET/CT for clinical staging and selection of patients with hepatocellular carcinoma for liver transplantation on the basis of Milan criteria: surgeon's perspective. J Nucl Med. 2013 Feb;54(2):192-200. doi: 10.2967/jnumed.112.107516. Epub 2013 Jan 15. — View Citation

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Ho CL, Yu SC, Yeung DW. 11C-acetate PET imaging in hepatocellular carcinoma and other liver masses. J Nucl Med. 2003 Feb;44(2):213-21. — View Citation

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Larsson P, Arvidsson D, Björnstedt M, Isaksson B, Jersenius U, Motarjemi H, Jacobsson H. Adding 11C-acetate to 18F-FDG at PET Examination Has an Incremental Value in the Diagnosis of Hepatocellular Carcinoma. Mol Imaging Radionucl Ther. 2012 Apr;21(1):6-12. doi: 10.4274/Mirt.87. Epub 2012 Apr 1. — View Citation

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Park JW, Kim JH, Kim SK, Kang KW, Park KW, Choi JI, Lee WJ, Kim CM, Nam BH. A prospective evaluation of 18F-FDG and 11C-acetate PET/CT for detection of primary and metastatic hepatocellular carcinoma. J Nucl Med. 2008 Dec;49(12):1912-21. doi: 10.2967/jnumed.108.055087. Epub 2008 Nov 7. — View Citation

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   American College of Radiology Manual on Contrast Media Version 10 2015