Irradiation in Paediatrics: Neurocognition, Neuroimaging and Evaluation of Memory and Attention (IPANEMA)

April 8, 2026 updated by: Institut Claudius Regaud

This is a prospective, open-label, multicentric study designed to correlate the dose delivered to the hippocampus with declarative memory deficits 2 years after radiotherapy treatment in a paediatric population who had received brain irradiation between the ages of 4 and 12 for a brain tumour.

In order to meet this objective, several neuropsychological assessments consisting of parental questionnaires and cognitive tests will be carried out during the course of the study, at the following two stages:

  • A 1st assessment at patient inclusion, i.e. 2 years after the end of radiotherapy treatment,
  • And a second assessment 2 years after patient inclusion, i.e. 4 years after the end of radiotherapy treatment.

A retrospective assessment of the patient's neurocognitive level 1 year before the diagnosis of the disease will also be carried out at inclusion, with the parents completing a questionnaire specifically designed for the trial.

In addition, patients who have received their radiotherapy treatment at the IUCT-O will be offered participation in the ancillary imaging study. If the parents and the patient agree, multimodal MRI scans specific to the study (without injection of contrast) will be performed at inclusion and 2 years after inclusion.

Imaging and radiotherapy data will be collected in parallel using the PediaRT software used in current practice (collection of radiotherapy dosimetric data as well as standard MRI examinations pre-operatively, post-operatively, and at the 2-year and 4-year follow-up).

130 patients will be included in this study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angers, France
      • Bordeaux, France
      • Caen, France
      • Dijon, France
        • Not yet recruiting
        • Centre Georges Francois Leclerc
        • Contact:
      • Lille, France
        • Not yet recruiting
        • Centre Oscar Lambret
        • Contact:
      • Lyon, France
        • Recruiting
        • Centre Léon Bérard
        • Contact:
      • Marseille, France
        • Not yet recruiting
        • APHM - Hôpital la Timone
        • Contact:
      • Montpellier, France
      • Paris, France
      • Rennes, France
      • Saint-Herblain, France
      • Strasbourg, France
        • Recruiting
        • Centre Paul Strauss
        • Contact:
      • Toulouse, France
      • Vandœuvre-lès-Nancy, France
      • Villejuif, France
        • Recruiting
        • Institut Gustave Roussy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient who has received localised brain irradiation or craniospinal irradiation for a brain tumour whose treatment includes first-line radiotherapy.
  2. Patient with one of the following tumour types: ependymomas, medulloblastomas, malignant germ cell tumours, craniopharyngioma, pinealoblastoma.
  3. Patient aged between 4 and 12 years at the time of radiotherapy treatment.
  4. End of irradiation within 2 years (+/-3 months) prior to inclusion.
  5. Patient having been treated by photontherapy or proton therapy.
  6. Sufficient visual, auditory (with authorised hearing aid) and oral or written expression capacity to carry out the neuropsychological tests properly.
  7. Proficiency in the French language by the patient and parent(s).
  8. Patient affiliated to a Social Security scheme in France.
  9. Informed consent signed by the patient/legal parent(s)/guardian(s) in accordance with French law and Good Clinical Practice.

Exclusion Criteria:

  1. Patient presenting with severe ataxia.
  2. Patient with a recurrence of the disease.
  3. Not applicable since protocol version 2. Metastatic patient.
  4. Any contraindication to MRI for patients included in Toulouse (i.e. in particular patients with a pacemaker or cardiac defibrillator, implanted equipment activated by an electrical, magnetic or mechanical system, patients with haemostatic clips on intracerebral aneurysms, patients with orthopaedic implants, claustrophobic patients).
  5. Patients undergoing psychostimulant or psychotropic treatment (in particular methylphenidate, antidepressants).
  6. Any psychological, family, geographical or sociological condition that prevents compliance with medical monitoring and/or the procedures set out in the study protocol.
  7. Patients deprived of their liberty or under legal protection.
  8. Severe posterior fossa syndrome with akinetic mutism.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with a brain tumour treated with radiotherapy in the first line 2 years prior to inclusion.
Other: Neuropsychological assessments:

Several neuropsychological assessments were carried out during the study (at inclusion and 2 years after inclusion), consisting of :

  • parental questionnaires (standard questionnaires and questionnaires specifically drawn up for the trial). The aim of these questionnaires will be to assess the patient's neurocognitive level at different times (before and after radiotherapy treatment).
  • patient cognitive tests (½ day face-to-face consultation/assessment with a neuropsychologist specialising in paediatrics, followed by a 30-minute telephone call).

Only for patients having received their radiotherapy treatment at the IUCT-O: a multimodal MRI specific to the study (without injection of contrast product) may be performed at inclusion and 2 years after inclusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A deficit of the declarative memory will be defined by a standard score of the Children' Memory Scale (CMS) ≤ 5
Time Frame: 24 months for each patient
24 months for each patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Declarative memory will be assessed using the adapted EPIREAL test.
Time Frame: 24 months for each patient
24 months for each patient
Declarative memory will be assessed by the autobiographical memory question.
Time Frame: 24 months for each patient
24 months for each patient
The deficit of the procedural memory will be defined by a score of less than or equal to 10/20 on the last 20 trials (out of 50) of the probabilistic classification task.
Time Frame: 24 months for each patient
24 months for each patient
The deficit of the procedural memory will be defined by a specific learning score less than or equal to zero of the adapted serial reaction time task (SRTT).
Time Frame: 24 months for each patient
24 months for each patient
Working memory deficit will be defined if at least one of the two subtests (Number memory (WISC-V) and Spatial memory (WNV)) shows a deficit.
Time Frame: 24 months for each patient
For each subtest, a deficit will be defined respectively by a standard score ≤ 5 and a percentile rank ≤ 5.
24 months for each patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2025

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

October 1, 2030

Study Registration Dates

First Submitted

September 5, 2024

First Submitted That Met QC Criteria

September 12, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24TETE01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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