Whole Body MRI Screening for Li-Fraumeni Syndrome

Recruiting at 2 trial locations

Overseen By Allison O'Neill, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Active cancer, Metastatic disease, Metal devices, others

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

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is evaluating Whole Body MRI as a possible screening tool to diagnose cancer for people with LFS and other inherited cancer predisposition syndromes.

Will I have to stop taking my current medications?

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

Is whole-body MRI screening safe for humans?

Whole-body MRI screening is generally considered safe for humans, as it does not use ionizing radiation, which is a concern for people with Li-Fraumeni syndrome who are sensitive to radiation. However, there is a high rate of false-positive results, which can lead to unnecessary stress and additional testing. ^{1 2 3 4 5}

How does whole-body MRI screening differ from other treatments for Li-Fraumeni Syndrome?

Whole-body MRI screening is unique for Li-Fraumeni Syndrome because it uses magnetic resonance imaging to regularly check the entire body for tumors without exposing patients to radiation, which they are particularly sensitive to. This approach helps in early detection of various cancers associated with the syndrome, unlike other methods that might not cover the whole body or could involve radiation. ^{1 2 3 4 6}

What data supports the effectiveness of the treatment Whole Body MRI for Li-Fraumeni Syndrome?

Whole Body MRI (WB-MRI) is effective in identifying asymptomatic tumors in individuals with Li-Fraumeni Syndrome, as shown in studies where it detected malignant tumors in some patients who showed no symptoms. This screening method is particularly useful for people with this syndrome because they are at high risk for multiple types of cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Allison O'Neill, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults and children with Li-Fraumeni Syndrome or other inherited cancer predisposition syndromes. Participants must be in stable remission from any previous cancers, not pregnant, and able to give informed consent. It excludes those currently with active cancer (except certain types), pregnant/nursing women, and anyone with metal implants that affect MRI safety.

Inclusion Criteria

I am 18 years old or older.

I have a genetic condition that increases my cancer risk.

I had cancer before, but it's been stable and 6 months since I finished my treatment.

Exclusion Criteria

I cannot have sedation or general anesthesia due to health reasons.

You have a metal heart valve, surgical clips, a pacemaker, or any other metal device inside your body that could cause problems during an MRI.

I am not pregnant or nursing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Whole Body MRI Scanning

Participants undergo Whole Body MRI scans to detect early-stage cancers

4 years

Annual scans

Follow-up

Participants are monitored for detection of prevalent and incident cancers

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Whole Body MRI

Trial Overview The study is testing the use of Whole Body MRI as a screening method to detect early-stage cancers in individuals who have genetic conditions that make them more likely to develop cancer, such as Li-Fraumeni Syndrome.

How Is the Trial Designed?

Group I: Whole Body MRI Experimental Treatment 1 Intervention

* Magnetic resonance imaging will be performed on participants * Participants who are two young to tolerate the scans awake, can receive sedation/anesthesia

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Whole body magnetic resonance imaging (WB-MRI) and brain MRI baseline surveillance in TP53 germline mutation carriers: experience from the Li-Fraumeni Syndrome Education and Early Detection (LEAD) clinic. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Whole-body magnetic resonance imaging of Li-Fraumeni syndrome patients: observations from a two rounds screening of Brazilian patients. [2019]

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

Li-Fraumeni Syndrome and Whole-Body MRI Screening: Screening Guidelines, Imaging Features, and Impact on Patient Management. [2021]

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

Baseline Surveillance in Li-Fraumeni Syndrome Using Whole-Body Magnetic Resonance Imaging: A Meta-analysis. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Whole-Body MRI Surveillance-Baseline Findings in the Swedish Multicentre Hereditary TP53-Related Cancer Syndrome Study (SWEP53). [2022]

6. England pubmed.ncbi.nlm.nih.gov

Psychosocial effects of whole-body MRI screening in adult high-risk pathogenic TP53 mutation carriers: a case-controlled study (SIGNIFY). [2021]