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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03176836
Other study ID # 1000053416
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date June 20, 2016
Est. completion date December 31, 2025

Study information

Verified date April 2023
Source The Hospital for Sick Children
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 30
Est. completion date December 31, 2025
Est. primary completion date July 1, 2025
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada The Hospital for Sick Children Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Through study completion, an average of 2 years
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