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TerminatedNCT01744054Updated Mar 5, 2018

Microsphere Localization Using PET/MRI or PET/CT in Patients Following Radioembolization

A Phase 1 interventional study of PET/MR and PET/CT in Liver Neoplasms, sponsored by Washington University School of Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-05.

Sponsored by Washington University School of Medicine · Phase 1, Interventional, and Diagnostic

Why this study was terminated
Logistics regarding PET/CT portion of study

From the registry’s dates

  • Primary completion was Apr 2017, 9 years 6 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
57
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

The successful localization of the y90 microspheres by PET/MR and/or PET/CT scans would be a useful tool in individualizing patient care after the radioembolization procedure. The information from a PET/MR or PET/CT scan would allow for early evaluation of the technical success of the procedure.

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Conditions studied

  • Liver Neoplasms

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03

In context

Liver Neoplasms

1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.

This study's enrollment of 57 is above the median of 47 across 968 interventional studies indexed under Liver Neoplasms.

Browse Liver Neoplasms studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participant must successfully complete the MRI screening form if receiving an MRI
  • Participant must be scheduled to undergo radioembolization for any indication
  • Participant must be ≥ 18 years of age
  • Participant must be able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document

Exclusion criteria

Exclusion Criteria:

  • Participant must not have any contraindications to MRI scanning
  • Patient must not be pregnant or breastfeeding
  • If agreeing to MRI contrast, participant must not have renal insufficiency (glomerular filtration rate (GFR \< 30 mL/min/1.73 m2) measured within the past 60 days
  • If agreeing to MRI contrast, participant must not be on dialysis
  • If agreeing to MRI contrast, participant must not have had a prior allergic reaction to gadolinium-based contrast agents
  • PET/MRI or PET/CT is not able to be scheduled within 72 hours of radioembolization
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Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
57 participants (actual)

Study arms

  • Other
    PET/MR or PET/CT

    * Patients must have had radioembolization, within 72 hours of the PET/MR or PET/CT * Subjects will be asked to lie still within the scanner for up to 1.5 hours while images are acquired for the liver

    Device: PET/MR · Device: PET/CT

Interventions

  • DevicePET/MR
  • DevicePET/CT
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What researchers measure

Primary outcomes

  1. Evaluate y90-PET/MRI and PET/CT for potential on reporting presence of extrahepatic deposition of microspheres

    A diagnostic radiologist and a nuclear medicine physician will evaluate the images and will determine any presence of extrahepatic deposition of microspheres.

    Time frame: 1 day (one time event for patient)

  2. Evaluate y90-PET/MRI and PET/CT for potential on reporting technical success of radioembolization

    A diagnostic radiologist and a nuclear medicine physician will evaluate the images and will determine whether technical success of the procedure can be determined. They will rate the images if they are 'adequate' to report on these two measures.

    Time frame: 1 day (one time event for patient)

07

Study locations

1 site
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
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References and documents

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01744054
Lead sponsor
Washington University School of Medicine
Responsible party
Sponsor
First posted
Dec 6, 2012
Start date
Oct 25, 2012
Primary completion
Apr 3, 2017
Completion
Apr 3, 2017
Last update
Mar 5, 2018

Study contacts

Parag Parikh, M.D.
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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