Whole Body MRI for Cancer Surveillance in A-T

NCT05252819 | Completed

• 1 other identifier: 21062
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ataxia Telangiectasia; Whole-body MRI; Cancer Surveillance

Outcome Measures

Primary Outcomes (3)

• Determine the feasibility of whole-body MRI for cancer surveillance in children and young people with A-T

  To establish the rate of completion of whole-body MRI protocol

  1 year

• Determine the feasibility of whole-body MRI for cancer surveillance in children and young people with A-T

  To establish the duration of scan tolerated (if not full protocol)

  1 year

• Determine the feasibility of whole-body MRI for cancer surveillance in children and young people with A-T

  To assess the diagnostic image quality

  1 year

Secondary Outcomes (7)

• Identification of concerns/views of the participants and their families/carers

  6 months

• Documentation of number of abnormal findings on whole-body MRI and blood metrics (when applicable)

  2 year

• Documentation of the locations of abnormal findings on whole-body MRI

  2 year

• Description of the type of abnormal findings on whole-body MRI and blood metrics (when applicable)

  2 year

• Rates of recommendations for further investigation based on whole-body MRI and/or blood test findings

  2 years

Interventions

Magnetic Resonance Imaging and an optional blood test DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children and young people with Ataxia Telangiectesia and their parents / carers from United Kingdom registred in Paediatric A-T clinic in Nottingham.

You may qualify if:

• 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

You may not qualify if:

• Contra-indication to MRI scan

Sponsors & Collaborators

• University of Nottingham: lead
• Action for A-T: collaborator
• Nottingham University Hospitals NHS Trust: collaborator

Study Sites (1)

University of Nottingham

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Ataxia Telangiectasia

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Spinocerebellar Ataxias; Cerebellar Ataxia; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocutaneous Syndromes; Ataxia; Dyskinesias; Neurologic Manifestations; Telangiectasis; Vascular Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Primary Immunodeficiency Diseases; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 23, 2022
• Study Start: October 17, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

GB (1)