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NCT05227482: DOSEY90

Accurate Dosimetry and Biomarkers Improve Survival in HCC Patients Treated With Resin 90 Yttrium (90Y)-Microspheres

Status unknown Phase 2 Last updated 7 February 2022
What this trial tests

Phase 2 trial testing Personalized dosimetry approach in HCC in 150 participants. Status unknown.

Timeline
10 April 2018
Primary endpoint
31 December 2023
31 December 2023

Quick facts

Lead sponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment150
Start date10 April 2018
Primary completion31 December 2023
Estimated completion31 December 2023
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

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):

  1. Overview of Ongoing Clinical Trials on Radioembolization.
    Fabritius MP, Ricke J. · · 2022 · cited 7× · PMID 36184696 · DOI 10.1007/s00270-022-03270-4
  2. 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:

Other recruiting trials for HCC

Currently open trials in the same condition.

Other IRCCS Azienda Ospedaliero-Universitaria di Bologna trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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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