Comparison of Whole Body DWI to FDG PET

University of California, San Francisco30 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Metastatic Cancer

Interventions

Fluorodeoxyglucose F18DRUG

Given IV as part of routine imaging

Positron Emission Tomography combined with Magnetic resonance imaging (PET/MRI)PROCEDURE

Imaging procedure

Whole Body Magnetic Resonance Imaging with Diffusion-Weighted Imaging (WB-MRI-DWI)PROCEDURE

Imaging procedure done concurrently with PET/MRI

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 18 years. 2. Non FDG PET imaging study scheduled to be performed within 60 days (before or after) of the research PET/MRI. 3. Ability to understand a written informed consent document, and the willingness to sign it. 4. Diagnosis of metastatic cancer. Exclusion Criteria: 1. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation. 2. Individuals with contraindications to MRI. This will be determined through review of the UCSF MRI screening form by qualified site personnel

Locations (1)

University of California, San Francisco

San Francisco, California, United States

RECRUITING

Outcomes

Primary Outcomes

Proportion of lesions characterized as positive

The overall proportion of lesions that will be characterized as positive on whole body (WB) diffusion weight imaging (DWI) and FDG PET.

Time frame: Up to 6 months

Secondary Outcomes

Inter-reader variability of diffusion weight imaging (DWI) interpretation

Inter-reader variability is the degree of agreement among independent observers who rate, code, or assess the same image. Eighteen regions per participant will be scored by two blinded readers at each time point and assessed for the presence of DWI positive disease (local disease; nodal disease: pelvic, retroperitoneal, thoracic, and other; osseous disease: skull, ribs and sternum, cervical/thoracic/lumbar spine, right/left pelvis, sacrum and upper/lower extremities; visceral disease: lung, liver, and other). Scores range from 0 to 1 with 1 being excellent agreement between the two readers.

Time frame: Up to 6 months

Central Contacts

Brad Kline

CONTACT

877-827-3222 brad.kline@ucsf.edu

Data from ClinicalTrials.gov

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