NCT05227482

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2018

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 7, 2022

Status Verified

January 1, 2022

Enrollment Period

5.7 years

First QC Date

January 10, 2022

Last Update Submit

January 26, 2022

Conditions

HCC

Keywords

radioembolizationrandomized trialvoxel dosimetry

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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)

    6 months

  • Tumor response in both arms as assessed by Response Evaluation Criteria in Solid Tumours (RECIST v1.1)

    3 years

  • Biomarkers prior and after the treatment

    3 months

  • Post-therapeutic dosimetry measured with Positron Emission Tomography - Computed Tomography (PET/CT) acquisition

    1 day

Study Arms (2)

Standard dosimetric approach for 90Y activity calculation

ACTIVE COMPARATOR

The radionuclide activity to be injected is calculated with standard dosimetric approach such as body surface area (BSA) method or Medical Internal Radiation Dose (MIRD) monocompartmental method.

Radiation: Standard dosimetry approach

Personalized voxel-based dosimetric method for 90Y activity calculation

EXPERIMENTAL

The radionuclide activity to be injected is calculated with voxel-based approach based on pre-treatment simulation with the injection of 99mTc-MAA and the acquisition of SPECT/CT images.

Radiation: Personalized dosimetry approach

Interventions

Personalized dosimetry approachRADIATION

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

Personalized voxel-based dosimetric method for 90Y activity calculation
Standard dosimetry approachRADIATION

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

Standard dosimetric approach for 90Y activity calculation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

Study Officials

  • lidia strigari, PhD MSc

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

lidia strigari, PhD MSc

CONTACT

00390512143570lidia.strigari@aosp.bo.it

carmine troiano

CONTACT

00390512143575fissansegr@aosp.bo.it

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Clinical Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Medical Physics Unit

Study Record Dates

First Submitted

January 10, 2022

First Posted

February 7, 2022

Study Start

April 10, 2018

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 7, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)