iBRA – Lithium treatment to prevent cognitive impairment after brain radiotherapy.

Phase 1

• Conditions: Brain tumor; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-504071-24-00
• Lead Sponsor: Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-22
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

Age equal or above 5 years., Age less than 18 years at time of radiotherapy, Has received cranial/craniospinal radiation treatment of brain tumor within the last 7 years., Adequate contraception to prevent pregnancy during the entire lithium treatment period and six months thereafter., Negative pregnancy test at screening, at start of study treatment, and monthly therafter., Written informed consent from patient and/or caregiver.

Exclusion Criteria

Allergy/hypersensitivity to lithium or any of the excipients, Renal failure (Cystatin C derived GFR < 60), Cardiac failure or heart disease, including Brugada syndrome (or family history thereof), Uncontrolled hypothyroidism, Pregnancy or breast feeding, Severe fluid or electrolyte imbalance, Karnofsky-Lansky score < 60, Other condition deemed incompatible with inclusion in this study (estimated 2 year survival prognosis less than 25 %, expected poor protocol compliance, language difficulties), Inclusion in other study protocol precluding inclusion in this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of lithium treatment after CNS radiotherapy for CNS malignancy in preventing late-appearing cognitive processing speed impairment (PSI) in children.;Secondary Objective: To assess the efficacy of lithium treatment through evaluation of other neuropsychological test scores, To assess the efficacy of lithium treatment through evaluation of radiological findings after lithium treatment using MRI, Exploratory objectives: To explore the feasibility of lithium treatment in this patient group.;Primary end point(s): Difference in Processing Speed Index (PSI) from baseline compared to two years later.