Clinical Trial: Magnetic Resonance Imaging Screening in Li Fraumeni Syndrome

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

Brief 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.

Detailed Summary:
Sponsor: Institute of Cancer Research, United Kingdom

Current Primary Outcome: Diagnosis of malignant disease [ Time Frame: Within 12 months of MRI scan ]

Following MRI scan further investigations may be required to diagnose malignancy


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Diagnosis of relevant non-malignant disease [ Time Frame: 12 months following MRI scan ]
    Further investigations may be required following the MRI to characterise such findings.
  • Diagnosis of non-relevant disease, number and type of investigations required [ Time Frame: 12 months following MRI ]
  • Psychological impact of MRI screening [ Time Frame: 12 months following MRI screening ]
    Psychological questionnaires to be completed at intervals up till 12 months post scan


Original Secondary Outcome: Same as current

Information By: Institute of Cancer Research, United Kingdom

Dates:
Date Received: November 27, 2012
Date Started: October 2012
Date Completion: December 2017
Last Updated: September 13, 2016
Last Verified: September 2016