Defining the Ablative Dose for Y-90 TARE

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT07586046
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • HCC - Hepatocellular Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Yttrium-90 Radiation Segmentectomy (Y90 RS) using glass microspheres — OTHER
    The 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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
May 2026
Primary completion
Feb 28, 2029
Completion
May 31, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cirrhotic
    Cirrhotic patients will begin at 300 Gy. Dose escalation will proceed in 100 Gy increments within each arm, with safety continuously evaluated by the Data Safety Monitoring Committee
  • Active Comparator: Non-cirrhotic
    Non-cirrhotic patients will begin at a dose of 200 Gy. Dose escalation will proceed in 100 Gy increments within each arm, with safety continuously evaluated by the Data Safety Monitoring Committee.

Primary Outcome Measure

Ablative Dose Threshold for Y90 Radiation Segmentectomy [ Time Frame: From enrollment to the end of post-treatment Y90 12 month follow up visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Andrew C Gordon, MD, PhD
[email protected]
(561)703-0134
Cameron Khakpour, BA
[email protected]
312-926-5509
Andrew C Gordon, MD, PhD (PRINCIPAL_INVESTIGATOR)
Robert J Lewandowski, MD, FSIR (SUB_INVESTIGATOR)
Amir A Borhani, MD (SUB_INVESTIGATOR)
Saad E Abu Zahra, MD (SUB_INVESTIGATOR)

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By research site
Northwestern University· Chicago, IL

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