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NCT05114148: iHEPAR
Individualized Dosimetry for Holmium-166-radioembolization in Patients With Unresectable Hepatocellular Carcinoma
NA trial testing Holmium-166 radioembolization in Hepatocellular Carcinoma Non-resectable in 30 participants. Status unknown.
1 November 2024
Quick facts
| Lead sponsor | UMC Utrecht |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 March 2022 |
| Primary completion | 1 November 2024 |
| Estimated completion | 1 November 2025 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Holmium-166 radioembolization
Conditions studied
- Hepatocellular Carcinoma Non-resectable — all drugs for Hepatocellular Carcinoma Non-resectable →
Sponsor
UMC Utrecht — full company profile →
Who can join
18 and older, any sex, with Hepatocellular Carcinoma Non-resectable. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients with hepatocellular carcinoma often die from intrahepatic disease because current treatment options are limited. Local treatment using 166Ho-radioembolization (166Ho-RE) offers a safe and effective treatment. Because 166Ho-microspheres are used as a scout dose for treatment simulaton and for the actual treatment itself, a tailored approach can be used. This concept has proven to be more predictive than the 90Y-radioembolization concept (current standard-of-care), which is a based on a surrogate scout dose (i.e. 99mTc-MAA). A personal treatment plan may be used for 166Ho-radioembolization to optimize efficacy, based on scout dose distribution. However, individualized treatment planning inherently leads to treatment doses that deviate from the currently approved 'one-size-fits-all' approach (i.e. 60 Gy average absorbed dose for all patients). Therefore, safety of individualized 166Ho-RE will be evaluated first to validate safety and confirm safety thresholds. These thresholds will be used in subsequent randomized controlled studies.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Holmium-166 Radioembolization: Current Status and Future Prospective.
Stella M, Braat AJAT, van Rooij R, de Jong HWAM, et al · · 2022 · cited 40× · PMID 35729423 · DOI 10.1007/s00270-022-03187-y -
Nano-radiopharmaceuticals as therapeutic agents.
Dixit T, Dave N, Basu K, Sonawane P, et al · · 2024 · cited 7× · PMID 38560384 · DOI 10.3389/fmed.2024.1355058 -
Overview of Ongoing Clinical Trials on Radioembolization.
Fabritius MP, Ricke J. · · 2022 · cited 7× · PMID 36184696 · DOI 10.1007/s00270-022-03270-4 -
Holmium-166 radioembolisation dosimetry in HCC.
Reinders MTM, Braat AJAT, van Erpecum KJ, de Bruijne J, et al · · 2025 · cited 5× · PMID 39470786 · DOI 10.1007/s00259-024-06940-2 -
Individualised dosimetry for holmium-166 RE in patients with unresectable hepatocellular carcinoma; a multi-centre, interventional, non-randomised, non-comparative, open label, phase II study: RHEPaiR.
Qurashi M, Martinez M, Ward C, Wyard C, et al · · 2025 · PMID 41263849 · DOI 10.1136/bmjopen-2024-097066
Verify or expand the search:
- PubMed search for NCT05114148
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Holmium-166 radioembolization
Trials testing the same drug.
- NCT03379844 — HEPAR Primary: Holmium-166-radioembolization in Hepatocellular Carcinoma Patients · Phase 2 · completed
Other recruiting trials for Hepatocellular Carcinoma Non-resectable
Currently open trials in the same condition.
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Other UMC Utrecht trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05114148 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by UMC Utrecht
- Last refreshed: 10 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05114148.
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