Clinical trial · Observational
A TheraSphere® Advanced Dosimetry Retrospective Global Study in HCC
A TheraSphere® Advanced Dosimetry Retrospective Global Study Evaluation in Hepatocellular Carcinoma Treatment
NCT03295006CI-TRIAL-00051384TARGETcompletedClinicalTrials.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 retrospective, multinational, single-arm study will be conducted in at least 8 sites. An interim analysis will be conducted with data from 100 patients with up to 10 well defined HCC tumor(s) and with at least one tumor ≥3 cm. Normal tissue absorbed dose using pre-procedural 99mTc MAA SPECT or SPECT/CT imaging will be measured to allow the mean absorbed normal tissue dose corresponding to a ≤15% probability of CTCAE grade 3 or higher hyperbilirubinemia (in the absence of disease progression) to be calculated. Total bilirubin will be recorded and graded according to CTCAE version 4.02. All dose-related SAEs at 3 months follow-up will be followed until resolution, death or lost-to-follow-up. AEs related to disease progression will not be considered related to TheraSphere.
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 |
|---|---|---|---|
| TheraSphere | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Previous Therasphere treatment
- description
- Patients who had received TheraSphere yttrium-90 microspheres
- interventionNames
- Device: TheraSphere
Primary outcomes (1)
- measure
- Alternative two-compartment TheraSphere dosimetry methodology
- timeFrame
- Baseline
- description
- Normal tissue absorbed dose using pre-procedural 99mTc MAA (Technetium-99m Macroaggregated albumin) SPECT (Single-photon emission computer tomography) or SPECT/CT (Single-photon emission computer tomography/Computer Tomography) imaging, to allow the mean absorbed normal tissue dose corresponding to a ≤15% probability of Common Toxicities Criteria for Adverse Events (CTCAE) grade 3 or higher hyperbilirubinemia (in the absence of disease progression) to be calculated.
Secondary outcomes (13)
- measure
- Tumor dose
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Up to 10 well defined unilobar/bilobar HCC tumor(s) per lobe with at least one tumor ≥3 cm ± PVT * Liver dominant disease (limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (up to 5 lesions in the lung, with each individual lesion ≤2cm; any number of lymph node lesions with each individual lesion ≤2 cm). * Child Pugh stage A or B7. * BCLC A, B or C. * Must be male or female, 18 years of age or older. * Bilirubin ≤2 mg/dL. * Tumor replacement \<50% of total liver volume assessed by diagnostic imaging consisting of multi-phase contrast enhanced CT or contrast enhanced MRI. * Diagnostic imaging consisting of multi-phase contrast enhanced CT or contrast enhanced MRI within 3 months prior to TheraSphere® administration. * Infusion of 99mTc-MAA in a single arterial location sufficient to cover up to 10 well-defined tumors per lobe ≤ 6 weeks prior to TheraSphere® administration. * Patients must have received TheraSphere® in a single treatment setting in one or more arterial locations sufficient to cover up to 10 well-defined tumors based on angiography. Subsequent TheraSphere® treatment to the second lobe may occur at least 4 weeks following the initial TheraSphere® treatment. * For patients receiving a second TheraSphere® treatment bilirubin levels must have been recorded prior to the second treatment * Patients must have had clinical evaluation (assessment of liver specific AEs) and laboratory evaluation (at least a serum bilirubin level) at baseline. * Tumor(s), ≥3 cm, measurable by mRECIST and RECIST 1.1 at baseline Exclusion Criteria: * Prior external beam radiation treatment to the liver. * Prior loco-regional liver directed therapy (cTACE, DEB-TACE and SIR-Spheres). * Prior liver transplantation. * Whole liver TheraSphere® treatment following prior liver resection. * TheraSphere administration to ≤2 segments (e.g., radiation segmentectomy). * Additional active therapy (TACE and treatment with SIR-Spheres) between first TheraSphere treatment and 3 month (90 days) imaging. * Hepatic vein invasion. * Diagnosis of disease progression at peri-procedural imaging as compared to the baseline imaging (physician's discretion).
References
Publications (3)
- DERIVEDLam M, Garin E, Haste P, Denys A, Geller B, Kappadath SC, Turkmen C, Sze DY, Alsuhaibani HS, Herrmann K, Maccauro M, Cantasdemir M, Dreher M, Fowers KD, Gates V, Salem R. Utility of pre-procedural [99mTc]TcMAA SPECT/CT Multicompartment Dosimetry for Treatment Planning of 90Y Glass microspheres in patients with Hepatocellular Carcinoma: comparison of anatomic versus [99mTc]TcMAA-based Segmentation. Eur J Nucl Med Mol Imaging. 2025 Jan;52(2):744-755. doi: 10.1007/s00259-024-06920-6. Epub 2024 Sep 27. PMID 39331131
- DERIVEDLam M, Garin E, Palard-Novello X, Mahvash A, Kappadath C, Haste P, Tann M, Herrmann K, Barbato F, Geller B, Schaefer N, Denys A, Dreher M, Fowers KD, Gates V, Salem R. Direct comparison and reproducibility of two segmentation methods for multicompartment dosimetry: round robin study on radioembolization treatment planning in hepatocellular carcinoma. Eur J Nucl Med Mol Imaging. 2023 Dec;51(1):245-257. doi: 10.1007/s00259-023-06416-9. Epub 2023 Sep 12. PMID 37698645
- DERIVEDLam M, Garin E, Maccauro M, Kappadath SC, Sze DY, Turkmen C, Cantasdemir M, Haste P, Herrmann K, Alsuhaibani HS, Dreher M, Fowers KD, Salem R. A global evaluation of advanced dosimetry in transarterial radioembolization of hepatocellular carcinoma with Yttrium-90: the TARGET study. Eur J Nucl Med Mol Imaging. 2022 Aug;49(10):3340-3352. doi: 10.1007/s00259-022-05774-0. Epub 2022 Apr 8. PMID 35394152