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Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy.

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Phase changed: Phase 1 → not applicable Show 7 more changesShow less
    • Primary completion moved earlier from May 2028 to Dec 31, 2026
    • Primary endpoints: details revised at 2 of 3 entries
    • Study completion moved earlier from Nov 2028 to Jun 30, 2028
    • Interventions modified
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 3 of 4 entries
    • Publications: details revised at 1 of 1 entry
  2. Enrollment closed, study ongoing
    • Site details revised
    v11
  3. Enrollment target: 65 to 70
    • Study description expanded, about 15 words
    v10
  4. Enrollment target: 45 to 65v9
  5. Re-verified, no change to tracked fieldsv8
Show 6 earlier versionsHide 6 earlier versions
  1. Eligibility criteria expanded, about 52 words
    • Study description expanded, about 33 words
    • Collaborators: 1 to 2
    • Study title shortened, about 2 words
    v7
  2. Primary completion date: Feb 2023 to May 2028
    • Study completion date: Feb 2025 to Nov 2028
    v6
  3. Primary completion date: Nov 2022 to Feb 2023
    • Study completion date: Sep 2024 to Feb 2025
    v5
  4. Re-verified, no change to tracked fieldsv4
  5. Start date changed from estimate of Sep 15, 2020 to Sep 16, 2020v3
  6. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Oct 2022 to Nov 2022
    • Study completion date: Aug 2024 to Sep 2024
    • Start date: Aug 20, 2020 to Sep 15, 2020
    • Site details revised
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study will investigate the combination of Ytrium-90 (Y-90) Selective Internal Radiation Therapy (SIRT) followed by Stereotactic Body Radiation Therapy (SBRT). Y-90 SIRT alone or SBRT alone are standard procedures used in the treatment of liver cancer. This study will assess the combination of Y-90 SIRT and SBRT and obtain preliminary information about the side effects and safety of the combination therapy. Additionally, this is the first time that Y-90 PET-CT imaging will be included in planning for SBRT.
Trial Details
NCT Number NCT04518748
Lead Sponsor University of Michigan Rogel Cancer Center
Collaborators: Department of Health and Human Services, National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Conditions
(from sponsor)		 Liver Malignancy
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov