Li-Fraumeni Syndrome Imaging Study
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|ClinicalTrials.gov Identifier: NCT03176836|
Recruitment Status : Enrolling by invitation
First Posted : June 6, 2017
Last Update Posted : June 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Li-Fraumeni Syndrome||Diagnostic Test: Whole body STIR MRI Diagnostic Test: DW-MRI Diagnostic Test: PET-MRI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Novel Approaches to Molecular and Clinical Surveillance in Li-Fraumeni Syndrome - Pilot Study.|
|Actual Study Start Date :||June 20, 2016|
|Estimated Primary Completion Date :||July 1, 2020|
|Estimated Study Completion Date :||December 31, 2020|
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
Standard technique that detects abnormalities related to excess of water in tissues (edema).
Diagnostic Test: DW-MRI
MRI technique that analyzes areas of dead cells within tissues, present in some types of tumor.
Diagnostic Test: PET-MRI
MRI technique that detect's the cells' use of glucose, more intensely in harmful cells.
- Evaluation of imaging traits on suspected tumors [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176836
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Andrea Doria, MD||The Hospital for Sick Children|