HCC Clinical Trial
— DOSEY90Official title:
Accurate Dosimetry and Biomarkers Improve Survival in HCC Patients Treated With Resin 90 Yttrium (90Y)-Microspheres: a Randomized Trial
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - hepatocellular carcinoma diagnosis (BCLC stage B or C) - appropriate liver function (Child-Pugh A or B<8) - life expectancy > 3 months - bilirubin < 2.0 ng/ml - multidisciplinary team consensus to the treatment - multiphasic CT within 1 month prior to the treatment - written informed consent Exclusion Criteria: - lung shunt fraction > 20% - Child-Pugh score C - BCLC stage D - liver impairment - relevant ascites - hepatic encephalopathy - vascular abnormality not allowing proper catheterization - significant distant metastasis |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Bologna |
Lead Sponsor | Collaborator |
---|---|
IRCCS Azienda Ospedaliero-Universitaria di Bologna | Regina Elena Cancer Institute |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | Patients overall survival after receiving the treatment will be recorded. Correlation between the patients survival and the assigned Arm will be assessed. | 3 years | |
Secondary | Related adverse events in both arms as assessed by National Cancer Institute criteria (National Cancer Institute Common Terminology Criteria for Adverse Events, CTCAE v.5.0) | Related adverse events will be assessed with CTCAE v.5.0. Only adverse events within 6 months from the treatment will be considered treatment-related and considered in the secondary outcome. | 6 months | |
Secondary | Tumor response in both arms as assessed by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) | Tumor response after the treatment will be assessed with Response Evaluation Criteria in Solid Tumours (RECIST v1.1). | 3 years | |
Secondary | Biomarkers prior and after the treatment | Biomarkers (PIVKA-II and Alpha-fetoprotein) values will be measured by blood samples prior the treatment (basal value) and at 1-month and 3-months follow-up after the treatment | 3 months | |
Secondary | Post-therapeutic dosimetry measured with Positron Emission Tomography - Computed Tomography (PET/CT) acquisition | Voxel-based dosimetry will be performed based on a PET/CT acquisition the day after the treatment. The dose delivered to the whole and healthy liver, the tumor and the lungs will be recorded. | 1 day |
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