Low Dose Y90 Microspheres for the Planning of Radioembolization Therapy in Patients with Stage A-C Liver Cancer

Active:	Yes
Cancer Type:	Liver Cancer / Hepatoblastoma Unknown Primary	NCT ID:	NCT04172714
Trial Phases:	Phase II	Protocol IDs:	RAD4784-19 (primary) NCI-2019-06505 IRB00112192
Eligibility:	18 Years and older, Male and Female	Study Type:	Diagnostic
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT04172714

Summary

This phase II trial studies the side effects and how accurate low dose Y90 microspheres works for determining the amount of blood that flows between the liver and the lungs for the purpose of radioembolization (Y90) therapy planning in patients with stage A-C liver cancer. Y90 microspheres are tiny beads filled with a radioactive agent called Y90 that are placed inside the blood vessel that provides blood supply to the tumor. Understanding the amount of blood flow can help researchers obtain an accurate estimation of Y90 radioembolization therapy in the tumor(s), liver and lungs. This is to ensure maximizing tumor response while minimizing the side effects to the normal liver and lungs.

Objectives

PRIMARY OBJECTIVE:
I. To compare the safety and accuracy/efficacy of low dose yttrium Y 90 (Y90) resin microspheres and macroaggregated albumin (MAA) in predicting the actual dose delivered to the tumor, liver, and lung after Y90 therapy.

SECONDARY OBJECTIVES:
I. To identify tumor dose response thresholds (TDRT) and tumor dose distribution in patients with hepatocellular carcinoma (HCC) treated with Y90 resin microspheres.
II. To optimize low dose Y90 techniques in predicting tumor to normal liver activity ration (TNR) and lung shunt fraction (LSF).

OUTLINE:
Patients undergo planning and mapping over 1 week. Patients receive low dose Y90 intra-arterially mapping and then receive therapeutic dose of Y90 intra-arterially for yttrium-90 microsphere radioembolization. Patients also undergo single photon emission computed tomography (SPECT)/computed tomography (CT) on the day of the mapping and 2 positron emission tomography (PET)/CT scans over 30 minutes either on the same day or the day after the planning and therapy respectively. Patients may undergo a second yttrium-90 microsphere radioembolization in 4 weeks if entire tumor is covered by the initial Y90 radioembolization therapy.

After completion of study treatment, patients are followed up at 1, 3, and 6 months and then every 3 months thereafter.

Treatment Sites in Georgia

Emory Clinic
1365 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

Emory University Hospital - Atlanta
1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

Emory University Hospital - Midtown
550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

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