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

NCT03896646 | Active Not Recruiting

• 3 other identifiers: 2018-1008NCI-2019-01586P30CA016672
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• Tumor objective response rate (ORR)

  Assessed with modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria. The ORR of treated tumors will be determined. Will perform a cluster bootstrap in which patients (not tumors) are sampled with replacement. Will construct a 95% confidence interval using the 2.5% and 97.5% quantiles of the bootstrap sampling distribution.

  Up to 6 months

Secondary Outcomes (6)

• Changes in liver function

  Up to 6 months

• Changes in Common Terminology Criteria for Adverse Events (CTCAE) incidence

  Up to 6 months

• Accuracy of published tumor dose response prediction based on the yttrium-90 (Y90) tumor dose volume histograms

  Up to 6 months

• Prediction of tumor doses macroaggregated albumin (MAA) scan with actual doses delivered (Y90 scan)

  Up to 6 months

• Development of tumor dose response model prediction based on MAA dose maps

  Up to 6 months

Study Arms (1)

Treatment (personalized radioembolization, SPECT/CT HIDA)

EXPERIMENTAL

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.

Procedure: Computed Tomography; Other: Hepatobiliary Iminodiacetic Acid Scan; Procedure: Single Photon Emission Computed Tomography; Radiation: Yttrium Y 90 Glass Microspheres; Procedure: Yttrium-90 Microsphere Radioembolization

Interventions

Computed Tomography PROCEDURE

Undergo SPECT/CT HIDA scan

Also known as: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography

Treatment (personalized radioembolization, SPECT/CT HIDA)

Hepatobiliary Iminodiacetic Acid Scan OTHER

Undergo SPECT/CT HIDA scan

Also known as: HIDA Scan

Treatment (personalized radioembolization, SPECT/CT HIDA)

Single Photon Emission Computed Tomography PROCEDURE

Undergo SPECT/CT HIDA scan

Also known as: Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, single-photon emission computed tomography, SPECT, SPECT imaging, SPECT SCAN, SPET, tomography, emission computed, single photon, Tomography, Emission-Computed, Single-Photon

Treatment (personalized radioembolization, SPECT/CT HIDA)

Yttrium Y 90 Glass Microspheres RADIATION

Undergo radioembolization with yttrium Y 90 glass microspheres

Also known as: TheraSphere

Treatment (personalized radioembolization, SPECT/CT HIDA)

Yttrium-90 Microsphere Radioembolization PROCEDURE

Undergo yttrium-90 microsphere radioembolization

Also known as: Yttrium Y 90 Microsphere Therapy, Yttrium-90 Radioembolization

Treatment (personalized radioembolization, SPECT/CT HIDA)

Eligibility Criteria

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

You may qualify if:

• Patients over 18 years of age, of any race or sex, who have unresectable hepatocellular carcinoma of the liver, and who are able or have a fully able legal guardian to give informed consent, will be eligible. Patients must have an ECOG Performance Status score of \</=2, with a life expectancy of \>/=3 months, and must be non-pregnant with an acceptable contraception in premenopausal women. Patients must be \>4 weeks since prior radiation or prior surgery and at least one month post chemotherapy.
• At least one lesion \>/= 3.0 cm in shortest dimension
• AST or ALT \<5 times ULN
• Bilirubin \</= 2.0 mg/dL (unless segmental infusion is used)
• Negative pregnancy test in premenopausal women

You may not qualify if:

• Contraindications to angiography and selective visceral catheterization
• Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) to the lungs with a single injection, or greater than 50 Gy for multiple injections
• Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow (eg, placing catheter distal to gastric vessels)
• Significant extrahepatic disease representing an imminent life-threatening outcome
• Severe liver dysfunction or pulmonary insufficiency
• Active uncontrolled infection
• Significant underlying medical or psychiatric illness
• Pregnant
• Pre-existing diarrhea/illness, co-morbid disease or condition that would preclude safe delivery of TheraSphere® treatment and place the patient at undue risk
• Infiltrative tumors

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

X-Rays; Photons

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

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Elementary Particles; Light; Optical Phenomena; Radiation, Nonionizing

Study Officials

• Armeen Mahvash

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 1, 2019
• Study Start: October 10, 2019
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

US (1)