MedTrace Logo

Long Term Neurocognitive Effects of Low-dose Radiation in the Brain: Study of 150 Patients in the French Hemangioma Cohort

NCT01960751 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2026-04-23

No results posted yet for this study

Summary

Context: Studies that address specifically the neurocognitive consequences that can be caused by low-dose radiation receiving during the childhood have still to be performed. In this issue, we focus on an investigation with patients who have received radiotherapy for a benign tumor (skin hemangioma), in France.

Patients and methods: More than 8300 children with a skin hemangioma were treated at Gustave Roussy (Île-de-France) from 1941 to 1973 and a number of them have received radiotherapy. These patients have been treated and followed by Gustave Roussy, so their clinical records can be tracked with great accuracy and the ionizing radiation dose to the brain have been estimated. From this patient cohort, the aim is to evaluate neurocognitive dysfunction or disorder that can be caused by low-dose radiation to the brain (less than one Gray (Gy)). A total of 150 patients is expected. They will be contacted by letter to explain the purpose and methods of carrying out tests. Two groups will be analysed according to the received ionizing radiation dose to the brain during the radiotherapy (exposed: 0.05 to 1 Gy, vs unexposed: less than 0.05 Gy). Tests exploring several cognitive functions (memory, arithmetic, orientation, etc.) will be used.

Expected results: We expect to describe the potential neurocognitive dysfunction or disorder and to identify risk factors and brain structures whose lesions are responsible for the neurocognitive dysfunction or disorder.

A therapeutic treatment will be proposed in the eventuality of screening of a neurocognitive dysfunction or disorder.

Conditions

  • Patients Treated by Radiotherapy With < One Gy to the Brain

Interventions

OTHER

neurocognitive tests battery

The two groups (exposed: 0.05 to 1 Gy; unexposed: less than 0.05 Gy) will receive the same neurocognitive tests battery.

Sponsors & Collaborators

  • European Commission

    collaborator OTHER

  • Gustave Roussy, Cancer Campus, Grand Paris

    collaborator OTHER

  • Institut National de la Santé Et de la Recherche Médicale, France

    lead OTHER_GOV

Principal Investigators

  • Chiraz EL-FAYECH · Gustave Roussy, France

  • Florent DE VATHAIRE · Institut National de la Santé Et de la Recherche Médicale, France

Study Design

Allocation
NA
Purpose
SCREENING
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-14
Primary Completion
2015-02-04
Completion
2015-02-04

Countries

  • France

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01960751 on ClinicalTrials.gov