ClinicalTrials.gg
CompletedNCT05252819Updated Nov 6, 2026Results posted

Whole Body MRI for Cancer Surveillance in A-T

An observational study in Ataxia Telangiectasia, sponsored by University of Nottingham. Completed at 1 site in United Kingdom. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by University of Nottingham · Observational

Updated Nov 6, 2026Results postedStudy documents posted+2 moreGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
37
Ages
4 Years to 18 Years
Sex
All
01

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.
Read the detailed description

Ataxia Telangiectasia (A-T) is an autosomal recessive disorder characterised with cerebellar neurodegeneration, immunodeficiency, respiratory disease and cancer susceptibility (22% by age 20). A-T is a complex disorder caused by mutations in the Ataxia Telangiectasia Mutated (ATM) gene which creates highly unstable ATM protein fragments. In the classical clinical presentation of A-T there is no kinase activity due to the absence of ATM protein. One consequence of this is that cellular DNA-repair pathways are compromised which allows breaks in DNA strands leading to genomic instability and/or cell death. As a result, there is an increase sensitivity to ionizing radiation and elevated cancer risk. Children less than 16 years with classical A-T demonstrate a predisposition to the development of different types of lymphoid cancers (lymphoma and leukaemia). However non-lymphoid tumours can also occur.

The current practice at the United Kingdom Paediatric A-T clinic for cancer surveillance is to perform blood testing, including full blood account, liver function tests and measurement of circulating tumour marker Alpha-fetoprotein. Full blood account can detect an increase white cell count and abnormal white cell populations and therefore, is effective in detecting most types of leukaemia. Elevation of Alpha-Fetoprotein can be a marker of different types of tumours, for example hepatocellular carcinoma and liver metastases, however is also often elevated in people with A-T. Therefore, its use for detecting cancer in A-T is uncertain and not currently evidence-based. The lack of evidence-based guidelines regarding the optimal cancer surveillance strategy in children with A-T could delay the diagnosis and consequently the treatment plan.

Magnetic Resonance Imaging (MRI) technology has progress rapidly since its discovery, making it possible currently to perform whole-body MRI scans with relatively short acquisition times. Presently, whole-body MRI protocols that include diffusion-weighted imaging and structural (T1/Dixon) acquisitions are used for diagnosing and monitoring cancers (sarcomas, metastases and haematological tumours like myeloma). A further advantage of this technique compared to computed tomography is that does not involve radiation, which is important given the elevated radiosensitivity of people with A-T.

The value of whole-body MRI in people with cancer predisposition has been shown in Li-Fraumeni syndrome, syndrome that, like A-T, is associated with increased risk of haematological and solid tumours. Despite the successful results of using a multimodality protocol for cancer surveillance in Li-Fraumeni syndrome, it cannot be assumed that the results will be the same in people with A-T as the also have respiratory and neurological dysfunction that could influence the tolerability and image quality of the MRI scans. Also, the profile of the tumours differs between these two syndromes. To date, the value of whole-body MRI for cancer surveillance in children and young people with A-T has not been demonstrated. It is unknown whether is possible to obtain diagnostic images, and the spectrum of findings (both cancer and non-cancer) that can be detected has not been reported.

In addition to technical considerations, it is vital to understand the perspectives of people affected by A-T regarding cancer surveillance. Participation in a cancer surveillance programme could increase anxiety for both the participant and family, and it is possible that negative psychological aspects could outweigh the perceived benefits or earlier cancer detection. Compared to other screening programmes, it should be noted that these families are already having to deal with a family member with complex progressive chronic disease, and so emotional and psychological capacity to deal with added anxiety may be limited. Hence, it is important to know, before conducting a full scale trial that will inform the current lack of evidence-based guidelines, whether cancer surveillance in children and young people with A-T using whole-body MRI is feasible and desirable.

02

Conditions studied

  • Ataxia Telangiectasia

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Keywords

  • Ataxia Telangiectasia
  • Whole-body MRI
  • Cancer Surveillance
03

In context

Ataxia Telangiectasia

42 studies on the registry are indexed under Ataxia Telangiectasia; 7 are open to participants now.

This study's enrollment of 37 is below the median of 60 across 12 observational studies indexed under Ataxia Telangiectasia.

Browse Ataxia Telangiectasia studies →

Lead sponsor

University of Nottingham is the lead sponsor of 465 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 (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

Exclusion criteria

Exclusion Criteria:

  • to MRI scan
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
37 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Interventions

  • Diagnostic testMagnetic 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

06

What researchers measure

Primary outcomes

  1. Number of Children and Young People With A-T Who Underwent the Whole-body MRI for Cancer Surveillance

    rate of completion of whole-body MRI protocol: number of children and young pleople with A-T who underwent the Whole-body MRI protocol

    Time frame: 1 year

  2. Number of Children and Young People With A-T Who Completed the Whole-body MRI for Cancer Surveillance

    duration of scan tolerated (if not full protocol): number of children and young people with A-T who completed the full whole-body MRI protocol, who partially completed the same protocol, and who did not do the whole body MRI scan

    Time frame: 1 year

  3. Image Quality of the Whole-body MRI for Cancer Surveillance

    Assessment of the diagnostic image quality - number of participants with Image quality between acceptable to excellent (threshold 65%) completing the scan

    Time frame: 1 year

Secondary outcomes

  1. Assessment of the Psychological Impact of the Participants and Their Families/Carers Throughout the Study

    Assessment of the participant/parent (carer) experience in the lead up to, during and after the surveillance MRI and blood test (when applicable), to assess the emotional impact regarding the diagnostic tests waiting times and to establish the emotional and informational support needed during the process of surveillance

    Time frame: 1 year

  2. Number of Abnormal Findings on Whole-body MRI and Blood Metrics (When Applicable)

    Assessment of the prevalence of cancer and non-cancer abnormalities detected on whole-body MRI in this population - number of participants with abnormal findings

    Time frame: 1 year

  3. Number of Participants Wtih Abnormal Findings According to Locations of Abnormal Findings on Whole-body MRI

    Assessment of the spectrum of cancer and non-cancer abnormalities detected on whole-body MRI in this population

    Time frame: 1 year

  4. Type of Abnormal Findings on Whole-body MRI and Blood Metrics (When Applicable)

    Assessment of the spectrum of cancer and non-cancer abnormalities detected on whole-body MRI in this population

    Time frame: 1 year

  5. Number of Children and Young People With A-T Who Were Recommended for Further Investigation

    Assessment of the rate of subsequent medical management based on the MRI and blood test (when applicable) findings

    Time frame: 1 years

07

Results

Posted Nov 6, 2026

Participant flow

Participant flow — Overall Study
MilestoneChildren and Young People With A-TParents
Started1819
Completed1617
Not completed22

Outcome measures

PrimaryNumber of Children and Young People With A-T Who Underwent the Whole-body MRI for Cancer Surveillance

rate of completion of whole-body MRI protocol: number of children and young pleople with A-T who underwent the Whole-body MRI protocol

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Children and Young People With A-T Who Underwent the Whole-body MRI for Cancer Surveillance
ParticipantsChildren and Young People With A-T
Number of Children and Young People With A-T Who Underwent the Whole-body MRI for Cancer Surveillance16
PrimaryNumber of Children and Young People With A-T Who Completed the Whole-body MRI for Cancer Surveillance

duration of scan tolerated (if not full protocol): number of children and young people with A-T who completed the full whole-body MRI protocol, who partially completed the same protocol, and who did not do the whole body MRI scan

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Children and Young People With A-T Who Completed the Whole-body MRI for Cancer Surveillance
ParticipantsChildren and Young People With A-T
Full scan15
Partially completed1
Scan not performed2
PrimaryImage Quality of the Whole-body MRI for Cancer Surveillance

Assessment of the diagnostic image quality - number of participants with Image quality between acceptable to excellent (threshold 65%) completing the scan

Time frame:
1 year
Reported as:
Count of participants · Participants
Image Quality of the Whole-body MRI for Cancer Surveillance
ParticipantsChildren and Young People With A-T
Image Quality of the Whole-body MRI for Cancer Surveillance16
SecondaryAssessment of the Psychological Impact of the Participants and Their Families/Carers Throughout the Study

Assessment of the participant/parent (carer) experience in the lead up to, during and after the surveillance MRI and blood test (when applicable), to assess the emotional impact regarding the diagnostic tests waiting times and to establish the emotional and informational support needed during the process of surveillance

Time frame:
1 year
Reported as:
Count of participants · Participants
Assessment of the Psychological Impact of the Participants and Their Families/Carers Throughout the Study
ParticipantsChildren and Young People With A-TParents
Anxiety is a familiar feeling117
MRI scanning is challenging for some children and families117
Preparation is essential to reduce stress117
Whole Body -MRI provides the reassurance about the physical health that families need117
Whole Body -MRI experience turned out to be a positive experience117
Whole Body -MRI allows families to be proactive117
SecondaryNumber of Abnormal Findings on Whole-body MRI and Blood Metrics (When Applicable)

Assessment of the prevalence of cancer and non-cancer abnormalities detected on whole-body MRI in this population - number of participants with abnormal findings

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Abnormal Findings on Whole-body MRI and Blood Metrics (When Applicable)
ParticipantsChildren and Young People With A-T
Number of Abnormal Findings on Whole-body MRI and Blood Metrics (When Applicable)4
SecondaryNumber of Participants Wtih Abnormal Findings According to Locations of Abnormal Findings on Whole-body MRI

Assessment of the spectrum of cancer and non-cancer abnormalities detected on whole-body MRI in this population

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Participants Wtih Abnormal Findings According to Locations of Abnormal Findings on Whole-body MRI
ParticipantsChildren and Young People With A-T
Brain16
Liver2
Breast1
Bone marrow1
Subcutaneous tissue2
SecondaryType of Abnormal Findings on Whole-body MRI and Blood Metrics (When Applicable)

Assessment of the spectrum of cancer and non-cancer abnormalities detected on whole-body MRI in this population

Time frame:
1 year
Reported as:
Count of participants · Participants
Type of Abnormal Findings on Whole-body MRI and Blood Metrics (When Applicable)
ParticipantsChildren and Young People With A-T
Cerebellar atrophy16
Benign cyst1
Subcutaneoues tissue oedema2
Abnormal bone marrow findings1
Granuloma disease2
SecondaryNumber of Children and Young People With A-T Who Were Recommended for Further Investigation

Assessment of the rate of subsequent medical management based on the MRI and blood test (when applicable) findings

Time frame:
1 years
Reported as:
Count of participants · Participants
Number of Children and Young People With A-T Who Were Recommended for Further Investigation
ParticipantsChildren and Young People With A-T
Number of Children and Young People With A-T Who Were Recommended for Further Investigation3

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Children and Young People With A-T0/18 (0%)0/18 (0%)0/18 (0%)
Parents0/19 (0%)0/19 (0%)0/19 (0%)

Baseline characteristics

Children and young people with Ataxia telangiectasia and their families

Age, Customized
Age, Customized(years)Children and Young People With A-TParentsTotal
Median11 (4 to 16)—11 (4 to 16)
Sex: Female, Male
Sex: Female, Male(Participants)Children and Young People With A-TParentsTotal
Participants enrolled — Female81321
Participants enrolled — Male10616
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Children and Young People With A-TParentsTotal
Count of participants——0
08

Study locations

1 site
  • University of Nottingham
    Nottingham, NG7 2UH, United Kingdom
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

10

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2022 to primary completion in Nov 2023, 13 months.

Results were first posted in Nov 2026, 2 years 11 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 4, 2022
First posted
Feb 23, 2022
StartActual
Oct 17, 2022
Primary completionActual
Nov 30, 2023
CompletionActual
Nov 30, 2023
Results first posted
Nov 6, 2026
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Results
Results posted
posted Nov 6, 2026
Enrollment
32→37
Nov 6, 2026
Primary outcomes
1 edited, 2 added, 2 removed
What changed in the outcomes
  • EditedDetermineImage Quality of the feasibility of wholeWhole-body MRI for cancer surveillance in children and young people with A-TCancer SurveillanceTime frame: 1 year
  • AddedNumber of Children and Young People With A-T Who Underwent the Whole-body MRI for Cancer SurveillanceTime frame: 1 year
  • AddedNumber of Children and Young People With A-T Who Completed the Whole-body MRI for Cancer SurveillanceTime frame: 1 year
  • RemovedDetermine the feasibility of whole-body MRI for cancer surveillance in children and young people with A-TTime frame: 1 year
  • RemovedDetermine the feasibility of whole-body MRI for cancer surveillance in children and young people with A-TTime frame: 1 year
Nov 6, 2026
Secondary outcomes
4 edited, 1 added, 3 removed
What changed in the outcomes
  • EditedIdentification of concerns/viewsAssessment of the participantsPsychological Impact of the Participants and their familiesTheir Families/carersCarers Throughout the StudyTime frame: 6 months → 1 year
  • EditedDocumentationNumber of number of abnormal findingsAbnormal Findings on wholeWhole-body MRI and blood metricsBlood Metrics (when applicableWhen Applicable)Time frame: 2 year → 1 year
  • EditedDocumentationNumber of the locationsParticipants Wtih Abnormal Findings According to Locations of abnormal findingsAbnormal Findings on wholeWhole-body MRITime frame: 2 year → 1 year
  • EditedDescriptionType of the type of abnormal findingsAbnormal Findings on wholeWhole-body MRI and blood metricsBlood Metrics (when applicableWhen Applicable)Time frame: 2 year → 1 year
  • AddedNumber of Children and Young People With A-T Who Were Recommended for Further InvestigationTime frame: 1 years
  • RemovedRates of recommendations for further investigation based on whole-body MRI and/or blood test findingsTime frame: 2 years
  • RemovedAssessment of the psychological impact of the participants and their families/carers throughout the studyTime frame: 1 year
  • RemovedEngagement of the international A-T communityTime frame: 6 months
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    Results posted
    Enrollment 32→37
    Primary outcomes 1 edited, 2 added, 2 removed
    What changed in the outcomes
    • EditedDetermineImage Quality of the feasibility of wholeWhole-body MRI for cancer surveillance in children and young people with A-TCancer SurveillanceTime frame: 1 year
    • AddedNumber of Children and Young People With A-T Who Underwent the Whole-body MRI for Cancer SurveillanceTime frame: 1 year
    • AddedNumber of Children and Young People With A-T Who Completed the Whole-body MRI for Cancer SurveillanceTime frame: 1 year
    • RemovedDetermine the feasibility of whole-body MRI for cancer surveillance in children and young people with A-TTime frame: 1 year
    • RemovedDetermine the feasibility of whole-body MRI for cancer surveillance in children and young people with A-TTime frame: 1 year
    Secondary outcomes 4 edited, 1 added, 3 removed
    What changed in the outcomes
    • EditedIdentification of concerns/viewsAssessment of the participantsPsychological Impact of the Participants and their familiesTheir Families/carersCarers Throughout the StudyTime frame: 6 months → 1 year
    • EditedDocumentationNumber of number of abnormal findingsAbnormal Findings on wholeWhole-body MRI and blood metricsBlood Metrics (when applicableWhen Applicable)Time frame: 2 year → 1 year
    • EditedDocumentationNumber of the locationsParticipants Wtih Abnormal Findings According to Locations of abnormal findingsAbnormal Findings on wholeWhole-body MRITime frame: 2 year → 1 year
    • EditedDescriptionType of the type of abnormal findingsAbnormal Findings on wholeWhole-body MRI and blood metricsBlood Metrics (when applicableWhen Applicable)Time frame: 2 year → 1 year
    • AddedNumber of Children and Young People With A-T Who Were Recommended for Further InvestigationTime frame: 1 years
    • RemovedRates of recommendations for further investigation based on whole-body MRI and/or blood test findingsTime frame: 2 years
    • RemovedAssessment of the psychological impact of the participants and their families/carers throughout the studyTime frame: 1 year
    • RemovedEngagement of the international A-T communityTime frame: 6 months
    + 3 other changes: verification date, contact details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT05252819
Collaborators
Action for A-T, Nottingham University Hospitals NHS Trust
Responsible party
Sponsor
First posted
Feb 23, 2022
Start date
Oct 17, 2022
Primary completion
Nov 30, 2023
Completion
Nov 30, 2023
Results posted
Nov 6, 2026
Last update
Nov 6, 2026

Study contacts

Robert Dineen, Prof
principal investigator · Professor of Neuroradiology • Mental Health and Clinical Neurosciences

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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