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

NCT03109262 | Completed Results DMC FDA Device

• 3 other identifiers: IRB-39332NCI-2017-00463VAR0147
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Malignant Liver Neoplasm

Outcome Measures

Primary Outcomes (1)

• Image Quality for 90-Y PET/CT Scans

  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.

  1 day

Secondary Outcomes (1)

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

  1 day

Study Arms (1)

Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans

EXPERIMENTAL

All participants receive both Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans

Procedure: Computed Tomography (CT); Procedure: Positron Emission Tomography (PET); Device: 90-Yttrium (Y-90) Glass Microspheres; Diagnostic Test: Technetium 99mTc albumin aggregated (99mTc-MAA); Procedure: Single-photon emission computerized tomography (SPECT) scan

Interventions

Computed Tomography (CT) PROCEDURE

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

Also known as: CAT, CAT Scan, Computed Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography, X-ray

Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans

Positron Emission Tomography (PET) PROCEDURE

As part of PET/CT scan

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans

90-Yttrium (Y-90) Glass Microspheres DEVICE

Radiolabel for PET/CT scan

Also known as: TheraSphere

Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans

Technetium 99mTc albumin aggregated (99mTc-MAA) DIAGNOSTIC_TEST

Radiolabel for 99mTc-MAA SPECT/CT Scan

Also known as: 99mTc-MAA

Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans

Single-photon emission computerized tomography (SPECT) scan PROCEDURE

As part of SPECT/CT scan

Also known as: SPECT Scan

Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patient is pregnant or nursing

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• 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 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

X-Rays; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Andrei Iagaru, PROFESSOR OF RADIOLOGY (NUCLEAR MEDICINE)
• Organization: Stanford University

aiagaru@stanford.edu

1650-725=4711

Study Officials

• Andrei Iagaru

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology (Nuclear Medicine)

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 12, 2017
• Study Start: February 15, 2017
• Primary Completion: May 30, 2019
• Study Completion: February 28, 2021
• Last Updated: January 10, 2022
• Results First Posted: September 9, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)