Imaging Techniques for Cancer Detection

Overseen By Brad Kline

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Noncompliance, MRI contraindications

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the treatment Positron Emission Tomography combined with Magnetic resonance imaging (PET/MRI) and Whole Body Magnetic Resonance Imaging with Diffusion-Weighted Imaging (WB-MRI-DWI) for cancer detection?

Research shows that combining PET/MRI with diffusion-weighted imaging (DWI) can improve the detection of cancerous lesions, making it a valuable tool for whole-body cancer staging. Studies also indicate that WB-MRI-DWI is effective in detecting primary and metastatic cancers, often performing comparably to or better than traditional PET/CT scans. ^{1 2 3 4 5}

Is whole-body MRI with diffusion-weighted imaging (WB-MRI-DWI) safe for humans?

The research does not specifically address safety concerns, but whole-body MRI with diffusion-weighted imaging (WB-MRI-DWI) is considered stable and widely used in clinical settings, suggesting it is generally safe for humans. ^{3 4 5 6 7}

How is the PET/MRI and WB-MRI-DWI treatment unique for cancer detection?

The PET/MRI and WB-MRI-DWI treatment is unique because it combines advanced imaging techniques to detect cancer without using radiation, unlike traditional PET/CT scans. This approach can provide detailed images of the whole body, potentially improving the detection of cancerous lesions while reducing exposure to harmful radiation. ^{3 4 5 8 9}

Research Team

Thomas A. Hope, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for individuals with known metastatic cancer. The details of the eligibility criteria are not provided, so it's important to contact the study organizers for specific inclusion and exclusion requirements.

Inclusion Criteria

I have a non-FDG PET scan scheduled around the time of the research PET/MRI.

Ability to understand a written informed consent document, and the willingness to sign it

My cancer has spread to other parts of my body.

Exclusion Criteria

Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants will be imaged at a single timepoint using whole body DWI concurrent with FDG PET/MRI

1 day

Optional Imaging

Participants may obtain an optional second FDG PET/MRI with DWI within 6 months

Up to 6 months

Follow-up

Participants are monitored through a medical records review for up to two years

Up to 2 years

Treatment Details

Interventions

• Positron Emission Tomography combined with Magnetic resonance imaging (PET/MRI)
• Whole Body Magnetic Resonance Imaging with Diffusion-Weighted Imaging (WB-MRI-DWI)

Trial Overview The trial is evaluating two imaging techniques in patients with metastatic cancer: Whole Body MRI with Diffusion-Weighted Imaging (WB-MRI-DWI) versus PET/MRI using Fluorodeoxyglucose F18. It aims to see which method is better at detecting cancer spread.

Participant Groups

Group I: Whole Body DWI plus FDG PET/MRI Experimental Treatment 4 Interventions

Participants will receive 5 to 10 Megabecquerel (MBq) +/- 10% of 18F-fluorodeoxyglucose as an intravenous injection and undergo a FDG PET/MRI scan that will extend from the vertex to the mid-thighs. Imaging will be performed from vertex to mid-thighs using standard protocol. Participants may also obtain an optional second FDG PET/MRI with DWI within 6 months.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Society of Abdominal Radiology

Collaborator

Trials

4

Recruited

200+

GE Healthcare

Industry Sponsor

Trials

307

Recruited

634,000+

Fotis Vlachos

GE Healthcare

Chief Marketing Officer since 2024

PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania

Peter J. Arduini

GE Healthcare

Chief Executive Officer since 2022

MBA from Northwestern University, BSc in Marketing from Susquehanna University

References

1. United States pubmed.ncbi.nlm.nih.gov

Non-small cell lung cancer: whole-body MR examination for M-stage assessment--utility for whole-body diffusion-weighted imaging compared with integrated FDG PET/CT. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Diagnostic accuracy of whole-body MRI/DWI image fusion for detection of malignant tumours: a comparison with PET/CT. [2021]

3. Ireland pubmed.ncbi.nlm.nih.gov

Diffusion-weighted imaging as part of hybrid PET/MRI protocols for whole-body cancer staging: does it benefit lesion detection? [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Diagnostic value of whole-body diffusion-weighted magnetic resonance imaging for detection of primary and metastatic malignancies: a meta-analysis. [2014]

5. Ireland pubmed.ncbi.nlm.nih.gov

Role of combined DWIBS/3D-CE-T1w whole-body MRI in tumor staging: Comparison with PET-CT. [2015]

6. Germany pubmed.ncbi.nlm.nih.gov

Simultaneous multislice diffusion-weighted imaging in whole-body positron emission tomography/magnetic resonance imaging for multiparametric examination in oncological patients. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Whole-body diffusion-weighted MR imaging in cancer: current status and research directions. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

[Whole-body diffusion-weighted imaging in oncology: technical aspects and practical relevance]. [2021]

9. Sweden pubmed.ncbi.nlm.nih.gov

Whole-body MRI including diffusion-weighted imaging compared to CT for staging of malignant melanoma. [2021]