Clinical trial · Observational
TheraSphere Post-Approval Study to Calculate the Radiation-absorbed Dose of Tc-99m MAA.
TheraSphere Post-approval Study to Calculate the Radiation-absorbed Dose of Technetium-99m Macroaggregated Albumin (Tc-99m MAA) to the Whole Body and Non-liver Critical Organs.
NCT05233098CI-TRIAL-00086827completedResults postedClinicalTrials.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)
The TheraSphere Post-Approval Study is a post-market, prospective, single-arm, open-label, observational study to support the use of TheraSphere for the treatment of hepatocellular carcinoma (HCC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Technetium-99m macroaggregated albumin (Tc-99m MAA) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Clinical Cohort
- description
- Patients enrolled in the study will have 3 imaging scans taken after Tc-99m MAA injection. The final scan will occur between 18 and 24 hours after Tc-99m MAA injection.
- interventionNames
- Device: Technetium-99m macroaggregated albumin (Tc-99m MAA)
Primary outcomes (11)
- measure
- Delivered Activity of Tc-99m MAA (MBq) for Whole Body
- timeFrame
- Immediately following
- description
- To provide imaging data calculating radiation-delivered dose of Tc-99m MAA to the whole body.
- measure
- Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs
- timeFrame
- Immediately following
- description
- To provide imaging data to calculate the radiation-delivered dose of Tc-99m MAA to the whole body and to potential irradiated non-liver critical organs.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients 21 years and older 2. Written informed consent 3. Patients who receive Tc-99m MAA while being evaluated for TheraSphere treatment. Exclusion Criteria: 1. Patients who are contraindicated for TheraSphere treatment. 2. Patients who are contraindicated for Tc-99m MAA per the applicable Package Insert. 3. Patients who do not receive Tc-99m MAA during pre-treatment Y-90 mapping
References
Publications (0)
Data not yet available
No reference posted for this study.