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Li-Fraumeni Syndrome Imaging Study

NCT ID: NCT03176836

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-20

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Li-Fraumeni Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MRI Imaging

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.

Group Type EXPERIMENTAL

Whole body STIR MRI

Intervention Type DIAGNOSTIC_TEST

Standard technique that detects abnormalities related to excess of water in tissues (edema).

DW-MRI

Intervention Type DIAGNOSTIC_TEST

MRI technique that analyzes areas of dead cells within tissues, present in some types of tumor.

PET-MRI

Intervention Type DIAGNOSTIC_TEST

MRI technique that detect's the cells' use of glucose, more intensely in harmful cells.

Interventions

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Whole body STIR MRI

Standard technique that detects abnormalities related to excess of water in tissues (edema).

Intervention Type DIAGNOSTIC_TEST

DW-MRI

MRI technique that analyzes areas of dead cells within tissues, present in some types of tumor.

Intervention Type DIAGNOSTIC_TEST

PET-MRI

MRI technique that detect's the cells' use of glucose, more intensely in harmful cells.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Andrea Doria

Radiologist, Senior Scientist, Research Director, Department of Diagnostic Imaging

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Doria, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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1000053416

Identifier Type: -

Identifier Source: org_study_id