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

Not Applicable

Completed

• Conditions: Patients Treated by Radiotherapy with < One Gy to the Brain
• Interventions: Other: neurocognitive tests battery

• Registration Number: NCT01960751
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Brief 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.

Detailed Description

CogRad is an interventional study designed within the European project called Cognitive and Cerebrovascular Effects Induced by Low Dose Ionizing Radiation (CerebRad).

CerebRad is a collaborative European project funded in 2011 within the 7th European Union (EU) framework programme, Nuclear Fission and Radiation Protection. CerebRad aims to identify the potential cognitive and cerebrovascular risks of radiation doses below 100 milliGray (mGy) when delivered to a young child (pre- or postnatally).

Study Timeline

• Study First Submitted: 2013-08-07
• Study First Submitted QC: 2013-10-08
• Study First Posted: 2013-10-11
• Study Start: 2014-04-14
• Primary Completion: 2015-02-04
• Study Completion: 2015-02-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Subject treated by radiotherapy for a skin hemangioma in childhood at Gustave Roussy between 1941 and 1973 and who have received less than 1 Gy of radiation doses in the brain
• Inhabitants of Île-de-France
• French medical insurance
• Good knowledge and understanding of the French language

Non-inclusion Criteria

• Cerebral hemangioma
• Syndrome genetic predisposition
• Pregnant woman
• Private person of liberty or under guardianship
• Radiation dose to the brain greater than 1 Gy during radiotherapy treatment of skin hemangioma
• Chemotherapy during skin hemangioma treatment
• Inability to undergo counseling for geographical reasons

Exclusion Criteria

• Pregnancy
• Inability to perform neurocognitive tests battery for medical reasons

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
neurocognitive tests	neurocognitive tests battery	neurocognitive tests battery (MMSE, SDS, SF-36, HAD, BPRS, RAVLT, FACT-Cog, MoCA)

Primary Outcome Measures

Name	Time	Method
All neurocognitive dysfunction or disorder on adults measured by means of eight tests	Participants will be tested for the duration of hospital stay (half a day).The neurocognitive tests battery will be carry out 56 years on average after exposure to low-dose radiation.	The score to the 8 tests will be correlate with the presence of neurocognitive dysfunction or disorder

Trial Locations

Locations (1)

Gustave Roussy; 🇫🇷 Villejuif, France