Li-Fraumeni Syndrome Imaging Study

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

Status

Enrolling by invitation

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03176836

Enrollment

Registered

2017-06-06

Start date

2016-06-20

Completion date

2025-12-31

Last updated

2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Li-Fraumeni Syndrome

Brief summary

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_TESTWhole body STIR MRI

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

DIAGNOSTIC_TESTDW-MRI

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

DIAGNOSTIC_TESTPET-MRI

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of imaging traits on suspected tumors	Through study completion, an average of 2 years	Imaging traits include: signal heterogeneity, mass effect, and neurovascular bundle involvement (recorded on STIR MRI); necrosis, and signal/necrosis ratio (recorded on STIR and DW MRI): FDG metabolic activity and uptake (PET-MRI) or other additional imaging findings. Results will be combined and analyzed for extraction of imaging-gene expression phenotypes.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026