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Recruiting NCT06630845

Comparison of Whole Body DWI to FDG PET

No phase Interventional Metastatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fluorodeoxyglucose F18, Positron Emission Tomography combined with Magnetic resonance imaging (PET/MRI), Whole Body Magnetic Resonance Imaging with Diffusion-Weighted Imaging (WB-MRI-DWI), General Electric (GE) SIGNA PET/MR.
Who it may be relevant to
Registry conditions: Metastatic Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison of Whole Body DWI to FDG PET Using PET/MRI

Overview

This is a single arm prospective trial that evaluates whole body diffusion weight imaging (DWI) compared to 18F-fludeoxyglucose (FDG) Positron Emission Tomography with Magnetic resonance imaging (PET/MRI) in participants with known metastatic cancer.

Detailed description

PRIMARY OBJECTIVE:

I. Correlation of DWI and FDG to detect disease.

SECONDARY OBJECTIVE:

I. Inter-reader variability of DWI interpretation by region.

OUTLINE:

Participants will be imaged at a single timepoint using whole body DWI concurrent with FDG PET/MRI within 60 days of receiving a non-FDG PET (either PET/CT or PET/MRI). There will be an optional PET/MRI performed within six months of the original study. Participants will be followed up through a medical records review for up to two years.

Interventions

  • Drug Fluorodeoxyglucose F18
    Given IV as part of routine imaging
  • Procedure Positron Emission Tomography combined with Magnetic resonance imaging (PET/MRI)
    Imaging procedure
  • Procedure Whole Body Magnetic Resonance Imaging with Diffusion-Weighted Imaging (WB-MRI-DWI)
    Imaging procedure done concurrently with PET/MRI
  • Device General Electric (GE) SIGNA PET/MR
    Imaging device

Primary outcome measures

  • Proportion of lesions characterized as positive [Time frame: Up to 6 months]
Secondary outcome measures (1)
  • Inter-reader variability of diffusion weight imaging (DWI) interpretation [Time frame: Up to 6 months]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years.
  • Non FDG PET imaging study scheduled to be performed within 60 days (before or after) of the research PET/MRI.
  • Ability to understand a written informed consent document, and the willingness to sign it.
  • Diagnosis of metastatic cancer.

Exclusion criteria

  • Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
  • Individuals with contraindications to MRI. This will be determined through review of the UCSF MRI screening form by qualified site personnel

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • University of California, San Francisco — San Francisco

Identifiers

NCT: NCT06630845 · 24926 · NCI-2024-09278

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗