Advanced MRI Techniques for Li-Fraumeni Syndrome

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Disqualifiers: Ferromagnetic prostheses, pacemaker, claustrophobia

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment DW-MRI, PET-MRI, Positron Emission Tomography-Magnetic Resonance Imaging, PET-MRI, Integrated PET/MRI, Whole body STIR MRI for Li-Fraumeni Syndrome?

Whole-body MRI (magnetic resonance imaging) is recommended for assessing cancer-prone syndromes like Li-Fraumeni Syndrome, and PET/MRI (Positron Emission Tomography-Magnetic Resonance Imaging) is seen as promising for cancer imaging, providing detailed anatomical and metabolic information that can help in diagnosing and monitoring treatment. ^{1 2 3 4 5}

Is whole-body MRI safe for humans?

Whole-body MRI is generally considered safe for humans as it does not use ionizing radiation, unlike some other imaging methods. It has been used effectively for screening and monitoring in various conditions, including cancer predisposition syndromes like Li-Fraumeni syndrome. ^{2 4 6 7 8}

How does the treatment using advanced MRI techniques differ from other treatments for Li-Fraumeni Syndrome?

Advanced MRI techniques, such as whole-body MRI, are unique for Li-Fraumeni Syndrome as they provide a comprehensive screening method to detect multiple types of tumors early in high-risk individuals, unlike traditional treatments that may not offer such extensive surveillance. ^{2 3 4 6 9}

What is the purpose of this trial?

Li-Fraumeni Syndrome (LFS) is a cancer predisposition disorder in which most affected individuals develop cancer during their lifetime. The majority of LFS patients carry a mutation in a gene called TP53, whose normal function is to control cell growth and prevent cells with damaged DNA from becoming cancerous. There is currently no way to determine when, where or what type of tumour will develop. This project will use novel techniques utilizing magnetic resonance imaging (MRI) to determine how sensitive they are at detecting very small tumors and how specific they are in terms of distinguishing malignant tumors from benign tumors.

Research Team

Andrea Doria, MD

Principal Investigator

The Hospital for Sick Children

Eligibility Criteria

This trial is for individuals with Li-Fraumeni Syndrome (LFS), a condition that greatly increases cancer risk. Participants must either carry a known TP53 mutation or be direct relatives of mutation carriers. They cannot take part if they have metal implants, pacemakers, or severe claustrophobia due to the MRI requirements.

Inclusion Criteria

My family has a known TP53 mutation, and I might carry it too.

Exclusion Criteria

You have metal implants in your body that are not safe for an MRI scan.

You are afraid of small, enclosed spaces.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo MRI imaging using standard and novel techniques to detect and differentiate tumors

2 years

Regular imaging sessions as per study protocol

Follow-up

Participants are monitored for safety and effectiveness of imaging techniques

4 weeks

Treatment Details

Interventions

• DW-MRI
• PET-MRI
• Whole body STIR MRI

Trial Overview The study is testing advanced MRI techniques including PET-MRI, Whole body STIR MRI, and DW-MRI to detect small tumors in LFS patients. It aims to determine how effective these methods are at identifying malignant versus benign tumors.

Participant Groups

Group I: MRI Imaging Experimental Treatment 3 Interventions

Participants will be imaged with the standard MRI technique (STIR-MRI) and also new MRI techniques called "diffusion weighted" or "DW" MRI and Positron Emission Tomography (PET)-MRI. PET-MRI will be indicated if the results from the routine MRI and DW MRI are contradictory or if laboratory results do not correspond to the standard MRI and DW MRI results.

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Findings from Research

The introduction of combined PET/MRI systems at Rigshospitalet has shown promising results in imaging various types of cancer, including brain tumors and pediatric oncology, indicating that it performs well compared to traditional PET/CT imaging.

While initial clinical cases suggest that PET/MRI could enhance cancer diagnosis and treatment monitoring, further large-scale studies are necessary to determine the optimal use of this technology in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET/MRI in cancer patients: first experiences and vision from Copenhagen. Kjær, A., Loft, A., Law, I., et al.[2021]

Whole-body magnetic resonance imaging (MRI) has become a crucial tool in pediatric oncology, significantly improving the screening, diagnosis, and follow-up of children with solid tumors while avoiding the risks associated with ionizing radiation from traditional imaging methods.

The use of advanced metabolic and functional MRI techniques enhances the ability to assess tumor response and stage disease, contributing to better treatment outcomes for pediatric patients, especially when cancers are diagnosed early.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-body MRI in pediatric patients with cancer. Guimarães, MD., Noschang, J., Teixeira, SR., et al.[2018]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Whole-body magnetic resonance imaging (WB-MRI) in oncology: recommendations and key uses. [2022]

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

[Whole-body MRI in cancer predisposition syndromes]. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

PET/MRI in cancer patients: first experiences and vision from Copenhagen. [2021]

4. 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]

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

Does PET/MR Imaging Improve Cancer Assessments? Literature Evidence from More Than 900 Patients. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Whole-body MRI in pediatric patients with cancer. [2018]

8. 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]

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

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