Magnetic Resonance Imaging Screening in Li Fraumeni Syndrome

Li-Fraumeni Syndrome Clinical Trial

— SIGNIFY  

Official title:

Magnetic Resonance Imaging Screening In Li Fraumeni Syndrome: An Exploratory Whole Body MRI Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01737255
• Other study ID #: CCR3802
• Status: Completed
• Start date: October 2012
• Est. completion date: December 2017

Study information

• Verified date: March 2022
• Source: Institute of Cancer Research, United Kingdom
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is aimed at exploring the use of whole body MRI for early cancer detection in TP53 mutation carriers and population controls, with the hypothesis that more cancers will be detected in the TP53 mutation carrier group. A secondary end-point will be the number of incidental findings detected and subsequent investigations required. A series of questionnaires will be used to assess the psychological impact of screening on both the study and control group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Carrier of germline TP53 mutation which, in the view of the geneticist, is not known to be low penetrance OR non-related individual with no personal history of malignancy and no first degree relatives diagnosed with malignancy under the age of 50 years

• Please note, TP53 carrier cohort is complete and no longer open to recruitment

• Age between 18 and 60

• Able to give informed consent

Exclusion Criteria:

• Individual with low penetrance TP53 mutation

• Individual with TP53 variant of unknown significance.

• Previous malignancy diagnosed < 5 years ago in TP53 carriers (except non-melanomatous skin cancer or cervical CIS) Previous history of malignancy in non-related controls (except non-melanomatous skin cancer or cervical CIS)

• Current symptoms suggestive of malignancy

• Contraindication to MRI (such as non-MR compatible metal implants) as specified by the standard MR safety checklist

• Claustrophobia

• ECOG performance status >2

Related Conditions & MeSH terms

• Li-Fraumeni Syndrome
• Syndrome

Intervention

Other:
• Whole body MRI
Individuals will undergo whole body and brain MRI
• Psychological questionnaires
All recruits will complete questionnaires at 6 time points to assess psychological impact

Locations

Country	Name	City	State
United Kingdom	Cancer Genetics Unit, Royal Marsden Hospital	Sutton	Surrey

Sponsors (3)

Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom	Cancer Research UK, National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of malignant disease	Following MRI scan further investigations may be required to diagnose malignancy	Within 12 months of MRI scan
Secondary	Diagnosis of relevant non-malignant disease	Further investigations may be required following the MRI to characterise such findings.	12 months following MRI scan
Secondary	Diagnosis of non-relevant disease, number and type of investigations required		12 months following MRI
Secondary	Psychological impact of MRI screening	Psychological questionnaires to be completed at intervals up till 12 months post scan	12 months following MRI screening