Yttrium-90 Radiation Segmentectomy for Hepatocellular Carcinoma

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07110233
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • TheraSphere® Yttrium-90 microspheres — DEVICE
    Administered intra-arterially
  • Health Related Quality of Life Questionnaires (HRQOL) — OTHER
    Surveys administered

Study Details

This is a prospective, single-blinded, single-arm, open-label Phase II trial of trans-arterial radiation segmentectomy using Yttrium-90 glass microspheres (TheraSphere®) for Hepatocellular Carcinoma (HCC) participants with unresectable Barcelona clinic liver cancer (BCLC) stage A disease.

Key Dates

Start date
May 1, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
64 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Group 1. TheraSphere® Yttrium-90 microspheres
    Participants with a single tumor measuring 2-5 cm will receive one dose of TheraSphere® \>250 Gy, and ideally \> 400 Gy at the treating physician's discretion. Participants will be monitored for safety and complete quality of life questionnaires.
  • Experimental: Group 2. TheraSphere® Yttrium-90 microspheres
    Participants with 2-3 tumors ≤ 3 cm in diameter (T2 disease) will receive one dose of TheraSphere® \>250 Gy, and ideally \> 400 Gy at the treating physician's discretion. Participants will be monitored for safety and complete quality of life questionnaires.

Primary Outcome Measure

Objective Response Rate (ORR) by mRECIST [ Time Frame: Up to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Maya Aslam
(415) 514-8987
Ryan Lokken, MD (PRINCIPAL_INVESTIGATOR)

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