CClinicalTrials.gg
Enrolling by invitationNCT03176836Updated Apr 29, 2026

Li-Fraumeni Syndrome Imaging Study

An interventional study of Whole body STIR MRI and DW-MRI in Li-Fraumeni Syndrome, sponsored by The Hospital for Sick Children. Enrolling by invitation at 1 site in Canada. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
Up to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Li-Fraumeni Syndrome

Browse trials for

03

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • General contraindications for an MRI scan (ferromagnetic prostheses, pacemaker, or other implants incompatible with the magnetic field of the MR scanner), claustrophobia.
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    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.

    Diagnostic Test: Whole body STIR MRI · Diagnostic Test: DW-MRI · Diagnostic Test: PET-MRI

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.

05

What researchers measure

Primary outcomes

  1. Evaluation of imaging traits on suspected tumors

    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.

    Time frame: Through study completion, an average of 2 years

06

Study locations

1 site
  • The Hospital for Sick Children
    Toronto, Ontario M5G 1X8, Canada
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03176836
Lead sponsor
The Hospital for Sick Children
Responsible party
Andrea Doria (Radiologist, Senior Scientist, Research Director, Department of Diagnostic Imaging, The Hospital for Sick Children) — Principal investigator
First posted
Jun 6, 2017
Start date
Jun 20, 2016
Primary completion
Dec 31, 2026 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Apr 29, 2026

Study contacts

Andrea Doria, MD
principal investigator · The Hospital for Sick Children

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion