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Advanced MRI Techniques for Li-Fraumeni Syndrome
N/A
Waitlist Available
Led By Andrea Doria, MD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
LFS kindreds who either carry a known TP53 mutation or are obligate mutation carriers
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will use new techniques to MRI to see how well it can detect small tumors, and if it can tell the difference between cancerous and non-cancerous tumors.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
There are generally no side effects associated with undergoing MRIs as they do not use ionizing radiation; however, some individuals may experience discomfort from lying still or anxiety due to the enclosed space.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My family has a known TP53 mutation, and I might carry it too.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluation of imaging traits on suspected tumors
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: MRI ImagingExperimental Treatment3 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PET-MRI
2018
N/A
~100
DW-MRI
2008
N/A
~50
Find a Location
Who is running the clinical trial?
The Hospital for Sick ChildrenLead Sponsor
711 Previous Clinical Trials
6,958,250 Total Patients Enrolled
Andrea Doria, MDPrincipal InvestigatorThe Hospital for Sick Children
2 Previous Clinical Trials
106 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have metal implants in your body that are not safe for an MRI scan.You are afraid of small, enclosed spaces.My family has a known TP53 mutation, and I might carry it too.
Research Study Groups:
This trial has the following groups:- Group 1: MRI Imaging
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.