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NCT Number: NCT06630845

Comparison of Whole Body DWI to FDG PET

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.

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Key information

Conditions

Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Location status: Recruiting

Location contact

Brad Kline

CONTACT

[email protected]

Thomas Hope, MD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

877-827-3222

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluorodeoxyglucose F18

Drug

Given IV as part of routine imaging

Other names: Fludeoxyglucose F18 (FDG), 2-deoxy-2-[fluorine-18]fluoro-D-glucose, Fluorodeoxyglucose

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

Procedure

Imaging procedure

Other names: PET/MRI

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

Procedure

Imaging procedure done concurrently with PET/MRI

Other names: WB-MRI-DWI

General Electric (GE) SIGNA PET/MR

Device

Imaging device

Other names: GE SIGNA PET/MR, SIGNA PET/MR

Primary outcomes

  1. Proportion of lesions characterized as positive

    Time frame: Up to 6 months

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

Secondary outcomes

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

    Time frame: Up to 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Brad Kline

CONTACT

[email protected]

877-827-3222

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • GE Healthcare
  • Society of Abdominal Radiology

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Oct 8, 2024
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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