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NCT03109262 · REGISTRY CONDITION SEARCH

Yttrium-90 (Y90) Glass Microspheres PET/CT in Imaging Patients With Liver Tumors

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
COMPLETED
Registry last update
2022-01-10

This clinical trial studies how well yttrium-90 (Y90) glass microspheres positron emission tomography (PET)/computed tomography (CT) works in imaging patients with liver tumors . Images produced by PET/CT may provide better information about the distribution of particles, such as Y90 glass microspheres, delivered for selective internal radiation therapy (SIRT) as compared to regular medical care images useing technetium Tc-99m albumin-aggregated single photon emission computed tomography (SPECT)/CT images.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Image Quality for 90-Y PET/CT Scans

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outcome · POSTED

Radiopharmaceutical Dosimetry Accuracy for 90-Y PET/CT Scans and 99mTc-MAA SPECT/CT Scans

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Patient provides written informed consent * Patient is referred for 90Y SIRT radioembolization of liver tumor(s) * Patient is capable of complying with study procedures * Patient is able to remain still for duration of imaging procedure (approximately 30 minutes total for digital PET/CT) Exclusion Criteria: * Patient is pregnant or nursing
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    All participants receive both Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
    intervention Names
    1. Procedure: Computed Tomography (CT)
    2. Procedure: Positron Emission Tomography (PET)
    3. Device: 90-Yttrium (Y-90) Glass Microspheres
    4. Diagnostic Test: Technetium 99mTc albumin aggregated (99mTc-MAA)
    5. Procedure: Single-photon emission computerized tomography (SPECT) scan
    label
    Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
    description
    As part of PET/CT and SPECT/CT scans.
    name
    Computed Tomography (CT)
    other Names
    1. CAT
    2. CAT Scan
    3. Computed Tomography
    4. Computerized Axial Tomography
    5. Computerized Tomography
    6. CT
    7. CT SCAN
    8. tomography
    9. X-ray
    type
    PROCEDURE
  2. arm Group Labels
    1. Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
    description
    As part of PET/CT scan
    name
    Positron Emission Tomography (PET)
    other Names
    1. Medical Imaging, Positron Emission Tomography
    2. PET
    3. PET SCAN
    4. Positron Emission Tomography
    5. Positron Emission Tomography Scan
    6. Positron-Emission Tomography
    7. proton magnetic resonance spectroscopic imaging
    type
    PROCEDURE
  3. arm Group Labels
    1. Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
    description
    Radiolabel for PET/CT scan
    name
    90-Yttrium (Y-90) Glass Microspheres
    other Names
    1. TheraSphere
    type
    DEVICE
  4. arm Group Labels
    1. Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
    description
    Radiolabel for 99mTc-MAA SPECT/CT Scan
    name
    Technetium 99mTc albumin aggregated (99mTc-MAA)
    other Names
    1. 99mTc-MAA
    type
    DIAGNOSTIC_TEST
  5. arm Group Labels
    1. Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans
    description
    As part of SPECT/CT scan
    name
    Single-photon emission computerized tomography (SPECT) scan
    other Names
    1. SPECT Scan
    type
    PROCEDURE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
DIAGNOSTIC
Enrollment
count
42
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Image quality for 90Y PET/CT scan images was assessed relative to the expected image quality of Standard of Care (SoC) 99mTc-MAA SPECT/CT scans obtained from the same participant. Assessments were conducted at 5, 10, 15 and 20 minutes after infusion. Scans were assessed on a 1 to 5 Likert scale by 2 Nuclear Medicine physicians who were blinded to patient information. The Likert scale for image quality was established as follows: 1. = Non-diagnostic 2. = Suboptimal 3. = Acceptable 4. = Good 5. = Excellent, equivalent to a SoC 99mTc-MAA SPECT/CT scan The scans for each individual participant at each timepoint was scored on the Likert scale, as determined by the 2 Nuclear Medicine physicians. The outcome is reported as the overall mean of the physician determinations for each time point, with standard deviation.
    measure
    Image Quality for 90-Y PET/CT Scans
    time Frame
    1 day
secondary Outcomes
  1. description
    Radiopharmaceutical dosimetry was assessed based on the numerical tumor-absorbed dose value in Gray as calculated by SurePlan (MIM Software Inc, Cleveland, Ohio). The outcome is reported as the median tumor-absorbed dose in Gray for each scan method (90Y PET/CT and 99mTc-MAA SPECT/CT), with standard deviation.
    measure
    Radiopharmaceutical Dosimetry Accuracy for 90-Y PET/CT Scans and 99mTc-MAA SPECT/CT Scans
    time Frame
    1 day
Full study description
brief Summary
This clinical trial studies how well yttrium-90 (Y90) glass microspheres positron emission tomography (PET)/computed tomography (CT) works in imaging patients with liver tumors . Images produced by PET/CT may provide better information about the distribution of particles, such as Y90 glass microspheres, delivered for selective internal radiation therapy (SIRT) as compared to regular medical care images useing technetium Tc-99m albumin-aggregated single photon emission computed tomography (SPECT)/CT images.
detailed Description
PRIMARY OBJECTIVES: I. To evaluate the image quality of yttrium-90 (Y90) microspheres PET/CT post SIRT images as compared to technetium Tc-99m albumin aggregated (99mTc MAA) SPECT/CT. SECONDARY OBJECTIVES: I. To determine the superior accuracy in both distribution and dosimetry of Y90 PET/CT post-SIRT imaging compared to 99mTc MAA planar and SPECT/CT imaging. OUTLINE: Immediately after standard of care SIRT, patients receive Y90 glass microspheres and undergo PET/CT over 30 minutes. This study compares the experimental images to the regular medical care images in the same participant.
Source references
references
  1. citation
    Duan H, Khalaf MH, Ferri V, Baratto L, Srinivas SM, Sze DY, Iagaru A. High quality imaging and dosimetry for yttrium-90 (90Y) liver radioembolization using a SiPM-based PET/CT scanner. Eur J Nucl Med Mol Imaging. 2021 Jul;48(8):2426-2436. doi: 10.1007/s00259-021-05188-4. Epub 2021 Jan 14.
    pmid
    33443618
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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      1. context exact
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        exact text
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        start
        0
      offset unit
      unicode_code_points
      query cond
      Childhood Liver Cancer
      query disease state id
      ds-liver-cancer-pediatric
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-childhood-liver-cancer-000.json
      source file sha256
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      source json pointer
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      source kind
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      source string sha256
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    Preserved source evidence · Not medical advice