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Enrolling by invitation NCT03176836

Li-Fraumeni Syndrome Imaging Study

No phase Interventional Li-Fraumeni Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Whole body STIR MRI, DW-MRI, PET-MRI.
Who it may be relevant to
Registry conditions: Li-Fraumeni Syndrome. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Novel Approaches to Molecular and Clinical Surveillance in Li-Fraumeni Syndrome - Pilot Study.

Overview

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.

Interventions

  • Diagnostic test Whole body STIR MRI
    Standard technique that detects abnormalities related to excess of water in tissues (edema).
  • Diagnostic test DW-MRI
    MRI technique that analyzes areas of dead cells within tissues, present in some types of tumor.
  • Diagnostic test PET-MRI
    MRI technique that detect's the cells' use of glucose, more intensely in harmful cells.

Primary outcome measures

  • Evaluation of imaging traits on suspected tumors [Time frame: Through study completion, an average of 2 years]

Eligibility criteria

Inclusion criteria

  • LFS kindreds who either carry a known TP53 mutation or are obligate mutation carriers

Exclusion criteria

  • General contraindications for an MRI scan (ferromagnetic prostheses, pacemaker, or other implants incompatible with the magnetic field of the MR scanner), claustrophobia.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Canada · 1 center
  • The Hospital for Sick Children — Toronto

Identifiers

NCT: NCT03176836 · 1000053416

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗