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

New Imaging Technique Trial for Metastatic Cancer Patients

NCT: NCT06630845 · Status: RECRUITING · Phase: N/A · Sponsor: University of California, San Francisco · Started: 2025-02-06 · Est. Completion: 2029-10-31

Plain English Summary

Comparison of Whole Body DWI to FDG PET is a Not Applicable clinical trial sponsored by University of California, San Francisco studying Metastatic Cancer. This trial tests a new way to image cancer that has spread throughout the body using a combination of MRI and PET scans. It is for adults diagnosed with metastatic cancer who are scheduled for a standard PET scan. Participation involves undergoing a special PET/MRI scan and a whole-body MRI with DWI scan. Standard PET scans are the current alternative for imaging metastatic cancer. The trial aims to enroll 30 participants.

Official Summary

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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with a confirmed diagnosis of metastatic cancer can join. You must be scheduled for a standard PET scan within 60 days of the research scan. Individuals who cannot have an MRI due to medical reasons or who are unlikely to follow the study rules cannot participate. This trial is studying Metastatic Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures how often the new imaging technique correctly identifies cancerous spots, which helps doctors understand how well it can find cancer spread. The specific primary outcome measures are: Proportion of lesions characterized as positive (Up to 6 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial aims to improve cancer detection and monitoring by comparing a new whole-body MRI technique to a standard PET scan, potentially offering a more comprehensive view of metastatic disease. This research targets Metastatic Cancer, where improved treatment options are needed.

Investor Insight

This trial explores advanced imaging for a large patient population, potentially improving diagnostic accuracy and offering a competitive edge in the field of cancer imaging technology.

Is This Trial Right for Me?

Ask your doctor if this trial is a good fit for you and what the imaging procedure involves. You will undergo a special PET/MRI scan and a whole-body MRI with DWI scan. The study team will guide you through all procedures and requirements. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

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

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06630845?

NCT06630845 is a Not Applicable INTERVENTIONAL study titled "Comparison of Whole Body DWI to FDG PET." It is currently recruiting and is sponsored by University of California, San Francisco. The trial targets enrollment of 30 participants.

What conditions does NCT06630845 study?

This trial investigates treatments for Metastatic Cancer. The primary condition under study is Metastatic Cancer.

What treatments are being tested in NCT06630845?

The interventions being studied include: Fluorodeoxyglucose F18 (DRUG), Positron Emission Tomography combined with Magnetic resonance imaging (PET/MRI) (PROCEDURE), Whole Body Magnetic Resonance Imaging with Diffusion-Weighted Imaging (WB-MRI-DWI) (PROCEDURE), General Electric (GE) SIGNA PET/MR (DEVICE). Given IV as part of routine imaging

What does Not Applicable mean for NCT06630845?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT06630845?

This trial is currently "Recruiting." It started on 2025-02-06. The estimated completion date is 2029-10-31.

Who is sponsoring NCT06630845?

NCT06630845 is sponsored by University of California, San Francisco. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06630845?

The trial aims to enroll 30 participants. The trial is currently recruiting and accepting new participants.

How is NCT06630845 designed?

This is a interventional study, uses na allocation, follows a single_group design, employs none masking.

What are the primary outcomes being measured in NCT06630845?

The primary outcome measures are: Proportion of lesions characterized as positive (Up to 6 months). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06630845 being conducted?

This trial is being conducted at 1 site, including San Francisco, California (United States).

Where can I find official information about NCT06630845?

The official record for NCT06630845 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06630845. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06630845 testing in simple terms?

This trial tests a new way to image cancer that has spread throughout the body using a combination of MRI and PET scans. It is for adults diagnosed with metastatic cancer who are scheduled for a standard PET scan.

Why is this trial significant?

This trial aims to improve cancer detection and monitoring by comparing a new whole-body MRI technique to a standard PET scan, potentially offering a more comprehensive view of metastatic disease.

What are the potential risks of participating in NCT06630845?

The main risks are related to MRI, such as claustrophobia or issues with implanted medical devices. Potential side effects from the radioactive tracer used in PET scans are generally mild and temporary. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06630845?

Ask your doctor if this trial is a good fit for you and what the imaging procedure involves. You will undergo a special PET/MRI scan and a whole-body MRI with DWI scan. The study team will guide you through all procedures and requirements. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06630845 signal from an investment perspective?

This trial explores advanced imaging for a large patient population, potentially improving diagnostic accuracy and offering a competitive edge in the field of cancer imaging technology. This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves undergoing a special PET/MRI scan and a whole-body MRI with DWI scan. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.