150 Participants Needed

Whole Body MRI Screening for Li-Fraumeni Syndrome

Recruiting at 2 trial locations
AO
Overseen ByAllison O'Neill, MD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Dana-Farber Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 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.12345

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.12346

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.12345

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.

Research Team

AO

Allison O'Neill, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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.
See 7 more

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.
See 1 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Whole Body MRIExperimental Treatment1 Intervention
* Magnetic resonance imaging will be performed on participants * Participants who are two young to tolerate the scans awake, can receive sedation/anesthesia

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials
1,128
Recruited
382,000+

References

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]
Whole-body magnetic resonance imaging of Li-Fraumeni syndrome patients: observations from a two rounds screening of Brazilian patients. [2019]
Li-Fraumeni Syndrome and Whole-Body MRI Screening: Screening Guidelines, Imaging Features, and Impact on Patient Management. [2021]
Baseline Surveillance in Li-Fraumeni Syndrome Using Whole-Body Magnetic Resonance Imaging: A Meta-analysis. [2019]
Whole-Body MRI Surveillance-Baseline Findings in the Swedish Multicentre Hereditary TP53-Related Cancer Syndrome Study (SWEP53). [2022]
Psychosocial effects of whole-body MRI screening in adult high-risk pathogenic TP53 mutation carriers: a case-controlled study (SIGNIFY). [2021]
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