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Completed

NCT Number: NCT03109262

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

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.

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Key information

Conditions

Primary Malignant Liver Neoplasm Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computed tomography (CT)

Procedure

As part of PET/CT and SPECT/CT scans.

Other names: CAT, CAT Scan, Computed Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography, X-ray

Positron Emission Tomography (PET)

Procedure

As part of PET/CT scan

Other names: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

90-Yttrium (Y-90) Glass Microspheres

Device

Radiolabel for PET/CT scan

Other names: TheraSphere

Technetium 99mTc albumin aggregated (99mTc-MAA)

Diagnostic Test

Radiolabel for 99mTc-MAA SPECT/CT Scan

Other names: 99mTc-MAA

Single-photon emission computerized tomography (SPECT) scan

Procedure

As part of SPECT/CT scan

Other names: SPECT Scan

Primary outcomes

  1. Image Quality for 90-Y PET/CT Scans

    Time frame: 1 day

    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:

    • = Non-diagnostic
    • = Suboptimal
    • = Acceptable
    • = Good
    • = 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.

Secondary outcomes

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

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

High Quality Imaging and Dosimetry of Yttrium-90 (90Y) SIRT Using a Digital PET/CT

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Apr 12, 2017
Registry last updated
Jan 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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