IMAT-Neuroblastoma

A randomised Phase I/II study of Intensity Modulated Arc Therapy techniques in abdominal neuroblastoma

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10746820

Enrollment

Registered

2017-02-13

Start date

2017-02-21

Completion date

Unknown

Last updated

2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specialty: Cancer, Primary sub-specialty: Children's Cancer and Leukaemia

Interventions

Participants will be randomised via paper-based telephone randomisation until the online remote database is live (https://www.cancertrials.bham.ac.uk/IMATlive). They will be randomised in a 1:1 ratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Any patient with high-risk neuroblastoma of the abdominal or pelvic regions who requires radical radiotherapy 2. Fit to receive radical radiotherapy 3. Aged 18 months or over at diagnosis 4. Informed consent from patient, parent or guardian 5. Documented negative pregnancy test for female patients of childbearing potential 6. Patient agrees to use effective contraception during the treatment period (patients of childbearing age)

Exclusion criteria

Exclusion criteria: Pregnant patient

Design outcomes

Primary

Measure	Time frame
The actual dose delivered to patients in Gy, covering total Gy given and in how many fractions is captured by form following end of treatment.	—

Secondary

Measure	Time frame
1. Acute toxicity is assessed using information acquired by telephone consultation or clinic visit at least weekly for the thirty days following the end of treatment 2. Local control is assessed as per standard practice (mIBG scans and cross-sectional imaging are typically performed) at 2 years after randomisation. In the absence of any other imaging modality being indicated for other purposes, an ultrasound examination or MRI scan is preferred to avoid additional radiation exposure. 3. Long-term side effects are recorded at 5 years after the patient was randomised according to the Late Toxicity RTOG scoring system. This information will be collected during routine clinic visits; no trial-specific visits are required. 4. Event-free survival (EFS) and overall survival (OS) are captured using case report forms at each follow up visit/phone call whether the patient is still alive and whether there is progression/recurrence. This is captured weekly post-treatment up until the end of thirty days post-treatment, then every 6 months until 2 years post-randomisation, then as per local practise from 2 years up until 5 years post-randomisation.	—

Measure

Time frame

1. Acute toxicity is assessed using information acquired by telephone consultation or clinic visit at least weekly for the thirty days following the end of treatment 2. Local control is assessed as per standard practice (mIBG scans and cross-sectional imaging are typically performed) at 2 years after randomisation. In the absence of any other imaging modality being indicated for other purposes, an ultrasound examination or MRI scan is preferred to avoid additional radiation exposure. 3. Long-term side effects are recorded at 5 years after the patient was randomised according to the Late Toxicity RTOG scoring system. This information will be collected during routine clinic visits; no trial-specific visits are required. 4. Event-free survival (EFS) and overall survival (OS) are captured using case report forms at each follow up visit/phone call whether the patient is still alive and whether there is progression/recurrence. This is captured weekly post-treatment up until the end of thirty days post-treatment, then every 6 months until 2 years post-randomisation, then as per local practise from 2 years up until 5 years post-randomisation.

—

Countries

England, Northern Ireland, Scotland, United Kingdom, Wales

Contacts

Public ContactLouise Moeller

imat@trials.bham.ac.uk+44 121 415 1060

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026