N/A
Completed N=6
TheraSphere Post-Approval Study to Calculate the Radiation-absorbed Dose of Tc-99m MAA.
Source: ClinicalTrials.gov NCT05233098 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Delivered Activity of Tc-99m MAA (MBq) for Whole Body — 67.322 MBq
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Delivered Activity of Tc-99m MAA (MBq) for Whole Body |
27.978 | — |
| PRIMARY Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs |
0.662 | — |
| PRIMARY Delivered Activity of Tc-99m MAA (MBq) for Non-Liver Critical Organs. |
8.640 | — |
| PRIMARY Delivered Activity of Tc-99m MAA (MBq) for Whole Body. |
1.694 | — |
| PRIMARY Absorbed Dose of Tc-99m MAA (mGy) for Whole Body. |
10.970 | — |
| PRIMARY Absorbed Dose of Tc-99m MAA (mGy) for Non-Liver Critical Organs |
4.812 | — |
| PRIMARY Effective Dose of Tc-99m MAA (mSv) Whole Body |
0.666 | — |
| PRIMARY Effective Dose of Tc-99m MAA (mSv/mBq) for Whole Body |
0.008 | — |
| PRIMARY Equivalent Dose of TC-99m MAA (mSV) for Non-Liver Critical Organs |
0.384 | — |
Eligibility Criteria
Inclusion Criteria
- Patients 21 years and older
- Written informed consent
- Patients who receive Tc-99m MAA while being evaluated for TheraSphere treatment.
Exclusion Criteria
- Patients who are contraindicated for TheraSphere treatment.
- Patients who are contraindicated for Tc-99m MAA per the applicable Package Insert.
- Patients who do not receive Tc-99m MAA during pre-treatment Y-90 mapping
Data sourced from ClinicalTrials.gov (NCT05233098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.