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LiBRA – Lithium treatment to prevent cognitive impairment after brain radiotherapy.
EU CTIS ID: 2023-504071-24-00
What this study is testing
To assess the efficacy of lithium treatment in preventing late-appearing cognitive processing speed impairment in children after brain radiotherapy for a CNS malignancy.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 4 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 participant and/or legal guardians.
You likely can't join if
- Allergy/hypersensitivity to lithium or any of the excipients
- Inclusion in another study protocol precluding inclusion in this study.
- 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
See the full eligibility 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 4 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 participant and/or legal guardians.
- Allergy/hypersensitivity to lithium or any of the excipients
- Inclusion in another study protocol precluding inclusion in this study.
- 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 conditions deemed incompatible with inclusion in this study (should be discussed with PI). This can include, but is not restricted to: o Estimated 2-year survival prognosis less than 25 %. o Serious psychiatric condition and/or suicidal thoughts. o Expected poor protocol compliance. o Language difficulties.
- Ongoing antitumoral therapy.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.