Clinical trial · Interventional
Radioembolization for HCC Patients With Personalized Yttrium-90 Dosimetry for Curative Intent (RAPY90D)
NCT03896646CI-TRIAL-00112459active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IIIA Hepatocellular Carcinoma AJCC v8 | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIIB Hepatocellular Carcinoma AJCC v8 | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
| Stage III Hepatocellular Carcinoma AJCC v8 | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
| Stage IVA Hepatocellular Carcinoma AJCC v8 | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
| Stage IVB Hepatocellular Carcinoma AJCC v8 | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Hepatocellular Carcinoma AJCC v8 | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
| Unresectable Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Procedure | — | UNRESOLVED |
| Hepatobiliary Iminodiacetic Acid Scan | Other | — | UNRESOLVED |
| Single Photon Emission Computed Tomography | Procedure | — | UNRESOLVED |
| Yttrium-90 Microsphere Radioembolization | Procedure | — | UNRESOLVED |
| Yttrium Y 90 Glass Microspheres | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (personalized radioembolization, SPECT/CT HIDA)
- description
- 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.
- interventionNames
- 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
Primary outcomes (1)
- measure
- Tumor objective response rate (ORR)
- timeFrame
- Up to 6 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. At least one lesion \>/= 3.0 cm in shortest dimension 3. AST or ALT \<5 times ULN 4. Bilirubin \</= 2.0 mg/dL (unless segmental infusion is used) 5. Negative pregnancy test in premenopausal women Exclusion Criteria: 1. Contraindications to angiography and selective visceral catheterization 2. 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 3. 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) 4. Significant extrahepatic disease representing an imminent life-threatening outcome 5. Severe liver dysfunction or pulmonary insufficiency 6. Active uncontrolled infection 7. Significant underlying medical or psychiatric illness 8. Pregnant 9. Pre-existing diarrhea/illness, co-morbid disease or condition that would preclude safe delivery of TheraSphere® treatment and place the patient at undue risk 10. Infiltrative tumors
References
Publications (0)
Data not yet available
No reference posted for this study.