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Pilot Study of Microsphere Localization Using PET/MRI in Patients With Liver Disease Following Radioembolization


N/A
18 Years
N/A
Open (Enrolling)
Both
Liver Neoplasms

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Trial Information

Pilot Study of Microsphere Localization Using PET/MRI in Patients With Liver Disease Following Radioembolization


Inclusion Criteria:



- Participant must successfully complete the MRI screening form

- Participant must be scheduled to undergo radioembolization for liver disease

- 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 is not able to be scheduled within 72 hours of radioembolization

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Evaluate y90-PET/MRI for its potential on reporting presence of extrahepatic deposition of microspheres

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Parag Parikh, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

201209062

NCT ID:

NCT01744054

Start Date:

October 2012

Completion Date:

October 2014

Related Keywords:

  • Liver Neoplasms
  • Neoplasms
  • Liver Diseases
  • Liver Neoplasms

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110