Feasibility of Whole-body MRI for Cancer Surveillance in Children and Young People With Ataxia Telangiectasia

Status: Completed
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 18
Healthy Volunteers: f
View:

• for MRI scan: Confirmed diagnosis of A-T Aged 5 to 18 years Able to undergo MRI scan without sedation or general anaesthetic, after age-appropriate preparation Able to give informed consent (if 16 or older), or have a parent guardian who is able to give informed consent

• for Post-participation interviews or focus group: Participants who underwent the MRI scan Able to give informed consent (if 16 or older), or have a parent guardian who is able to give informed consent Parents / carers of the participants who underwent the MRI scan Participants and / or parents/carers willing to consent

• for Delphi Study: medical professionals who have 3 years post-qualification experience in A-T medical professionals who are currently employed in a clinical area that is related to A-T

Locations
Other Locations
United Kingdom
University of Nottingham
Nottingham
Time Frame
Start Date: 2022-10-17
Completion Date: 2023-11-30
Participants
Target number of participants: 32
Sponsors
Collaborators: Nottingham University Hospitals NHS Trust, Action for A-T
Leads: University of Nottingham

This content was sourced from clinicaltrials.gov