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Yttrium Y 90 Glass Microspheres PET/CT in Imaging Patients With Liver Tumors

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ClinicalTrials.gov Identifier: NCT03109262
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Stanford University

Brief Summary:
This clinical trial studies how well yttrium Y 90 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 yttrium Y 90 glass microspheres, delivered for selective internal radiation therapy (SIRT) compared to the technetium Tc-99m albumin aggregated single photon emission computed tomography (SPECT)/CT images.

Condition or disease Intervention/treatment Phase
Primary Malignant Liver Neoplasm Diagnostic Test: Computed Tomography Diagnostic Test: Positron Emission Tomography Device: Yttrium Y 90 Glass Microspheres Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the image quality of yttrium Y 90 glass microspheres (90Y) 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 90Y PET/CT post SIRT imaging compared to 99mTc MAA planar and SPECT/CT imaging.

OUTLINE:

Immediately after standard of care SIRT, patients receive yttrium Y 90 glass microspheres and undergo PET/CT over 30 minutes.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: High Quality Imaging and Dosimetry of Yttrium-90 (90Y) SIRT Using a Digital PET/CT
Actual Study Start Date : February 15, 2017
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : February 15, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Yttrium

Arm Intervention/treatment
Experimental: Diagnostic (Yttrium Y 90 glass microspheres PET/CT)
Immediately after standard of care SIRT, patients receive yttrium Y 90 glass microspheres and undergo PET/CT over 30 minutes.
Diagnostic Test: Computed Tomography
Undergo PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT SCAN
  • tomography

Diagnostic Test: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET SCAN
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging

Device: Yttrium Y 90 Glass Microspheres
Standard of care
Other Name: TheraSphere




Primary Outcome Measures :
  1. Image quality of lesions detected with PET/CT assessed by 5-point Likert scale [ Time Frame: Up to 1 month ]
    Will be compared with the image quality of the lesions seen on the standard of care pre-therapy 99mTc-MAA SPECT/CT.


Secondary Outcome Measures :
  1. Radiopharmaceutical distribution and dosimetry accuracy of 90Y PET/CT [ Time Frame: Up to 1 month ]
    Will compare visual distribution discrepancies (if any) and numerical values calculated by SurePlan from both 99mTc MAA SPECT/CT and 90Y PET/CT images. Will use SurePlan software to edge-contour and calculate tumor radiation absorbed dose values in both 99mTc MAA SPECT/CT and 90Y PET/CT images. This software will convert counts/pixel on the images to radiation absorbed dose measure in gray.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109262


Contacts
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Contact: Risa Jiron 650-736-1598 rjiron@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Risa Jiron    650-736-1598    rjiron@stanford.edu   
Principal Investigator: Shyam Srinivas         
Principal Investigator: Andrei Iagaru         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Shyam Srinivas Stanford University
Principal Investigator: Andrei Iagaru Stanford University

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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT03109262     History of Changes
Other Study ID Numbers: VAR0147
NCI-2017-00463 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
39332 ( Other Identifier: Stanford IRB )
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors