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

NCT05227482 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-02-07

No results posted yet for this study

Summary

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.

Conditions

Interventions

RADIATION

Personalized dosimetry approach

The radionuclide activity to administer is calculated using personalized voxel-based dosimetry approach

RADIATION

Standard dosimetry approach

The radionuclide activity to administer is calculated using standard (BSA or MIRD) dosimetry approach

Sponsors & Collaborators

  • Regina Elena Cancer Institute

    collaborator OTHER

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • lidia strigari, PhD MSc · IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-10
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05227482 on ClinicalTrials.gov