NCT05252819Completed
Whole Body MRI for Cancer Surveillance in A-T
Feasibility of Whole-body MRI for Cancer Surveillance in Children and Young People With Ataxia Telangiectasia
Source: ClinicalTrials.gov · Last updated 7 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 32 (actual)
- First submitted
- 4 Feb 2022
- Start date
- 17 Oct 2022
- Primary completion date
- 30 Nov 2023
- Lead sponsor
- University of Nottingham
- Diseases
- Childhood cancers
- NCT number
- NCT05252819
What you commit to
- Study type: Observational
- Participants enrolled: 32
- From 17 Oct 2022 to the primary completion date, 30 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Contra-indication to MRI scan
Who the study is looking for
- 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
Age in the registry: 4 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Nottingham Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.