Defining the Ablative Dose for Y-90 TARE
ConditionHCC - Hepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University
About this trial
This study is being done to help doctors improve how they treat liver tumors that cannot be removed by surgery or treated with standard ablation techniques. The researchers want to find out the best amount of radiation that needs to be delivered to completely destroy (or ablate) parts of the liver that have cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of hepatocellular carcinoma (HCC), cholangiocarcinoma, or liver-dominant metastatic disease not amenable to surgical resection or ablation.
Age ≥18 years.
Child-Pugh class A or B liver function
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Disqualifiers
Extrahepatic metastases.
Pregnant or breastfeeding individuals.
Tumors requiring treatment of more than two Couinaud segments.
Known hypersensitivity to gadolinium-based contrast agents.
Trial design
Design model
Parallel
Treatments tested in this trial
Yttrium-90 Radiation Segmentectomy (Y90 RS) using glass microspheres
Other interventionThe objective of this study is to define an optimal "ablative dose" range for Y90 Radiation Segmentectomy that achieves complete sectoral ablation detectable on dual contrast MRI and to determine whether this dose-response relationship differs between cirrhotic and non-cirrhotic patients.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: CirrhoticActive comparator 1 intervention
Group B: Non-cirrhoticActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Ablative Dose Threshold for Y90 Radiation Segmentectomy
To prospectively define the "ablative dose" threshold for Y90 Radiation Segmentectomy (RS) using post-treatment PET dosimetry and hepatobiliary phase MRI
Time frame
From enrollment to the end of post-treatment Y90 12 month follow up visit2
Impact of Cirrhosis on Ablative Dose Requirements
To determine whether cirrhotic patients require a higher threshold dose for ablation compared to non- cirrhotic patients
Time frame
From enrollment to enrollment to post-treatment Y-90 12 month follow-up visitSecondary outcomes
1
Correlation of Y90 Dose with Imaging Biomarkers
To evaluate the correlation between delivered Y90 dose and imaging biomarkers, including signal loss on hepatobiliary phase MRI, ablative margins, extracellular volume fraction, and perfusion changes
Time frame
Assessed at 1, 4-9, and 12 month follow up visits2
Tumor Response and Time-to-Progression Assessment
To assess tumor response by mRECIST and determine time to progression (TTP)
Time frame
From enrollment to end of post-treatment Y-90 12 month follow up visit3
Safety and Tolerability of Escalating Y90 Doses
To assess the safety and tolerability of escalating segmental Y90 doses (200- 500 Gy) using Bayesian optimal interval (BOIN) dose-escalation design under Data and Safety Monitoring Committee (DSMC) oversight
Time frame
From enrollment to end of post-treatment Y90 12 month follow up visitOther outcomes
1
Pathologic Necrosis in Explanted Tumors
To evaluate complete pathological necrosis in explanted tumors from patients who undergo liver resection or transplantation
Time frame
From enrollment to end of post-treatment Y90 12 month follow-up visit2
Early Imaging Biomarkers for Ablation Success
To identify novel early imaging biomarkers (Eovist hepatobiliary phase defects, extracellular volume mapping, perfusion changes) that may serve as surrogates for ablation success
Time frame
From enrollment to post-treatment Y90 12 month follow-up visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Northwestern University
Lead sponsor
Radiological Society of North America
Collaborator
Robert H. Lurie Cancer Center
Collaborator
Source ClinicalTrials.gov