Whole Body MRI Screening for Li-Fraumeni Syndrome

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a Whole Body MRI (a type of imaging scan) can detect cancer early in individuals with certain genetic conditions that increase cancer risk. It focuses on those with Li-Fraumeni Syndrome (LFS) and other inherited cancer syndromes, which may involve a specific gene mutation or a strong family history of cancer. The trial suits individuals with these genetic conditions who are not currently battling active cancer. Participants must be in stable remission if they have had cancer before. The trial aims to improve early cancer detection and, consequently, treatment outcomes for these high-risk groups. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could lead to earlier cancer detection for those at high risk.

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.

What prior data suggests that Whole Body MRI is safe for screening?

Research has shown that whole-body MRI is a safe choice for people with Li-Fraumeni Syndrome (LFS). Because LFS patients are sensitive to radiation, MRI is recommended over scans that use radiation. Studies have found that whole-body MRI is effective for regular cancer checks in these individuals.

Screenings in Brazil and other research have demonstrated that whole-body MRI is easy for patients to handle, with no reports of major side effects. Experts recommend it for yearly exams to catch cancer early and improve long-term health.

In summary, whole-body MRI is considered safe, with no significant risks reported in past screenings. It is the preferred method for those at high risk of cancer due to its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about whole body MRI screening for Li-Fraumeni Syndrome because it offers a non-invasive method to detect cancer early across the entire body. Unlike traditional imaging techniques, which may focus on specific areas, whole body MRI provides a comprehensive view, potentially catching cancers that might otherwise be missed. This method can be particularly beneficial for individuals with Li-Fraumeni Syndrome, who are at higher risk for multiple types of cancer, offering a proactive approach to monitoring their health.

What evidence suggests that Whole Body MRI is effective for screening cancer in Li-Fraumeni Syndrome?

Research has shown that Whole Body MRI scans, which participants in this trial will undergo, effectively detect cancer early in individuals with Li-Fraumeni Syndrome (LFS), a genetic condition that increases cancer risk. Studies have found that these scans can detect cancer in 7-16% of individuals with LFS during their first scan. In another study, Whole Body MRI detected 41 out of 46 cancers at an early stage, indicating a 6% detection rate. Additionally, Whole Body MRI identified 9 cancers in 54 people, a higher detection rate than typically seen in the general population. This evidence suggests that Whole Body MRI is a valuable tool for early cancer detection in individuals with inherited cancer risks like LFS. ^{3 6 7 8 9}

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.

Individuals not pregnant at enrollment

I have a genetic condition that increases my cancer risk.

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. jmg.bmj.com jmg.bmj.com/content/early/2025/06/30/jmg-2025-110704

Evaluation of whole-body MRI for cancer early detection in ... Other studies have reported outcomes from single baseline WB-MRI scans in individuals with LFS12 14 18 with cancer detection in 7–16% of ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.10501

A prospective study of whole-body MRI (WBMRI) as part of ... Results: 162 eligible participants (pts) with LFS (127 adult, 35 pediatric) underwent a total of 477 WBMRIs; 119 (73%) underwent 3 or more.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39075300/

Baseline surveillance in Li Fraumeni syndrome using ... Whole-body MRI identified 41 out of 46 cancers at an early stage, achieving an overall detection rate of 6%. Whole-body MRI surveillance is a valuable method ...

4. asco.org asco.org/abstracts-presentations/ABSTRACT491020

A prospective study of whole-body MRI (WBMRI) as part of ... Conclusions: Annual WBMRI contributes substantially to detection of asymptomatic localized cancers among individuals with LFS but interval cancers remain common ...

5. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)02774-1/fulltext

1195P Whole-body magnetic resonance imaging (WB-MRI ... Overall, 9 cancers in 54 individuals were diagnosed with the help of WB-MRI. The rate of cancers detected in this cohort was higher than expected in a general ...

6. ajronline.org ajronline.org/doi/10.2214/AJR.20.23008

Li-Fraumeni Syndrome and Whole-Body MRI Screening Patients with LFS are very susceptible to radiation, therefore the use of whole-body MRI is recommended for regular cancer screening.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6092833/

observations from a two rounds screening of Brazilian patients The purpose of this study was to evaluate two rounds of whole-body magnetic resonance imaging (WB-MRI) which were conducted as a screening strategy for LFS ...

8. lfsassociation.org lfsassociation.org/whole-body-mri/

LFS Whole-Body MRI Consensus | Annual Screening ... LFSA recommends annual whole-body MRI scans for all individuals with LFS to improve early cancer detection and long-term outcomes.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37428016/

Rates of Intervention and Cancer Detection on Initial versus ... Li-Fraumeni Syndrome (LFS) is a hereditary cancer predisposition syndrome with up to 90% lifetime cancer risk. Cancer screening, including ...