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Whole Body MRI for Cancer Surveillance in A-T

NCT05252819 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2024-02-07

No results posted yet for this study

Summary

Ataxia Telangiectasia (A-T) is an inherited disorder characterised by cerebellar neurodegeneration, immunodeficiency and respiratory disease. People with A-T have abnormal DNA repair and consequently have an increased risk of cancer. Despite this, current guidelines for management of children and young people with A-T do not include cancer surveillance.

Improvements in MRI technology have allowed whole-body MRI (WB-MRI) scanning with relatively short acquisition times. Currently, WB-MRI protocols are used for diagnosing and monitoring some primary and secondary cancers, including cancer surveillance in people with the Li-Fraumeni syndrome, which is another genetic cancer predisposition syndrome. Therefore, the research team believe that whole-body MRI provides a safe method for cancer surveillance in children and young people with A-T. However, the investigators do not know whether cancer surveillance in children and young people with A-T using whole-body MRI is feasible and desirable.

The research team proposes a feasibility study of MRI-based cancer surveillance with qualitative evaluation of participant experience with the primary aim to establish:

* feasibility of whole-body MRI for cancer surveillance in children and young people with A-T
* views of, and psychological impact on, participants and families / carers participating in whole-body MRI for cancer surveillance.
* feasibility of conducting a formal screening trial in terms of statistical design, sample size, screening interval, comparator arms and international collaboration Completion of this study will provide us with evidence of technical feasibility, very strong evidence of child / family views, a viable formal screening trial design and an engaged international research community, allowing us to proceed to a formal trial establishing the efficacy of a cancer surveillance programme for children and young people with A-T.

Conditions

  • Ataxia Telangiectasia

Interventions

DIAGNOSTIC_TEST

Magnetic Resonance Imaging and an optional blood test

One whole-Body MRI that takes approximately 35minutes One blood test, which it is an optional component at this stage

Sponsors & Collaborators

  • Action for A-T

    collaborator UNKNOWN

  • Nottingham University Hospitals NHS Trust

    collaborator OTHER

  • University of Nottingham

    lead OTHER

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-17
Primary Completion
2023-11-30
Completion
2023-11-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05252819 on ClinicalTrials.gov