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

NCT ID: NCT01744054

Last Updated: 2018-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-25

Study Completion Date

2017-04-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type OTHER

PET/MR

Intervention Type DEVICE

PET/CT

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PET/MR

Intervention Type DEVICE

PET/CT

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Parag Parikh, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.siteman.wustl.edu

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

201209062

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Advanced Imaging for Pulmonary Fibrosis
NCT06532071 RECRUITING PHASE2