NCT03896646

Radioembolization for HCC Patients With Personalized Yttrium-90 Dosimetry for Curative Intent (RAPY90D)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial aims to improve hepatocellular carcinoma (HCC) tumor responses in patients undergoing Y90 radioembolization by using personalized dosimetry as part of treatment planning. Using standard calculations for Y90 doses may not be specific enough for individual patients given that there can be differences in how tumor cells and liver cells respond to radiation. Personalized dose plans may help improve treatment and outcomes in liver cancer.

Detailed description

PRIMARY OBJECTIVES: I. To achieve tumor objective response rates of 75% using voxel based dosimetry when the mean dose (Dmean) to tumor is targeted to be greater than 200 Gray (Gy). SECONDARY OBJECTIVES: I. Correlate changes in liver function and Common Terminology Criteria for Adverse Events (CTCAE) incidence to the mean absorbed dose to normal liver. II. Prospectively validate the accuracy of our published tumor dose response prediction based on the yttrium Y 90 glass microspheres (yttrium-90 \[Y90\]) tumor dose volume histograms (DVHs). III. Correlate predicted tumor doses macroaggregated albumin (MAA) scan with actual doses delivered (Y90 scan). IV. Develop a tumor dose response model prediction based on the MAA dose maps. V. Develop a model correlating normal liver radiation dose to liver function using single-photon emission computed tomography/computed tomography hepatobiliary iminodiacetic acid (SPECT/CT HIDA) imaging. VI. Develop a model correlating the relative tumor to normal liver enhancement on CT imaging and Cone beam CT imaging to the uptake on SPECT CT Tc99m MAA imaging (gold standard). VII. Compare tumor and normal liver doses estimations from SPECT CT Bremsstrahlung imaging to positron emission tomography (PET) CT imaging. OUTLINE: Patients undergo yttrium-90 microsphere radioembolization with yttrium Y 90 glass microspheres using personalized dose measurements. Patients also undergo SPECT/CT HIDA scan before radioembolization and 2-4 months after radioembolization. After completion of study treatment, patients are followed up at 3 and 6 months.

Conditions

• Stage III Hepatocellular Carcinoma AJCC v8
• Stage IIIA Hepatocellular Carcinoma AJCC v8
• Stage IIIB Hepatocellular Carcinoma AJCC v8
• Stage IV Hepatocellular Carcinoma AJCC v8
• Stage IVA Hepatocellular Carcinoma AJCC v8
• Stage IVB Hepatocellular Carcinoma AJCC v8
• Unresectable Hepatocellular Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo SPECT/CT HIDA scan
OTHER	Hepatobiliary Iminodiacetic Acid Scan	Undergo SPECT/CT HIDA scan
PROCEDURE	Single Photon Emission Computed Tomography	Undergo SPECT/CT HIDA scan
RADIATION	Yttrium Y 90 Glass Microspheres	Undergo radioembolization with yttrium Y 90 glass microspheres
PROCEDURE	Yttrium-90 Microsphere Radioembolization	Undergo yttrium-90 microsphere radioembolization

Timeline

• Start date: 2019-10-10
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2019-04-01
• Last updated: 2025-11-21

Locations

1 site across 1 country: United States