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

Liver Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01744054
• Other study ID #: 201209062
• Status: Terminated
• Phase: Phase 1
• First received: November 30, 2012
• Last updated: March 1, 2018
• Start date: October 25, 2012
• Est. completion date: April 3, 2017

Study information

• Verified date: March 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 57
• Est. completion date: April 3, 2017
• Est. primary completion date: April 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Liver Neoplasms

Intervention

Device:
• PET/MR

• PET/CT

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day (one time event for patient)
Primary	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.	1 day (one time event for patient)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine