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NCT05227482: DOSEY90
Accurate Dosimetry and Biomarkers Improve Survival in HCC Patients Treated With Resin 90 Yttrium (90Y)-Microspheres
Phase 2 trial testing Personalized dosimetry approach in HCC in 150 participants. Status unknown.
31 December 2023
Quick facts
| Lead sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 10 April 2018 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Personalized dosimetry approach
- Standard dosimetry approach
Conditions studied
- HCC — all drugs for HCC →
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna — full company profile →
Who can join
18 and older, any sex, with HCC. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This trial involves patients with hepatocellular carcinoma (HCC) diagnosis treated with transarterial radioembolization (TARE) with resin microspheres loaded with 90Y. Patients will be divided in two groups based on prescription method to calculate the therapeutic radionuclide activity to be injected. In arm A, standard dosimetric approach such as Body Surface Area (BSA) method and Medical Internal Radiation Dosimetry (MIRD) monocompartmental method will be used. In arm B, novel voxel-based dosimetry, based on pre-treatment simulation with 99m-Technetium (99mTc)-Macro Aggregated Albumin (MAA) injection and SPECT/CT image acquisition, will be used. The primary outcome will be the overall survival of patients included in arm A and arm B. Secondary outcomes will be adverse events, tumor response, biomarkers assessed from blood samples prior and after the treatment and voxel-based dosimetry obtained from post-treatment PET/CT images acquisitions.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Overview of Ongoing Clinical Trials on Radioembolization.
Fabritius MP, Ricke J. · · 2022 · cited 7× · PMID 36184696 · DOI 10.1007/s00270-022-03270-4 -
Review of brachytherapy clinical trials: a cross-sectional analysis of ClinicalTrials.gov.
Chen D, Parsa R, Chauhan K, Lukovic J, et al · · 2024 · cited 2× · PMID 38351013 · DOI 10.1186/s13014-024-02415-8
Verify or expand the search:
- PubMed search for NCT05227482
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for HCC
Currently open trials in the same condition.
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- NCT06717919 — HOPE Against Cancer Recurrence in HCC · Phase 4 · recruiting
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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 NCT05227482 (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 IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Last refreshed: 7 February 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/NCT05227482.
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