on-invasive characterization of paediatric brain tumours using metabolic imaging at high magnetic field

Recruiting

• Conditions: childhood brain cancer; Pediatric brain tumors; 10029211

• Registration Number: NL-OMON52792
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

- Children, 6-18 years with a brain tumour, including newly diagnosed patients,
patients undergoing active surveillance or patients with a recurrent brain
tumor
- Children in which tumor will remain in situ and who will undergo at least one
of the following treatment strategies: partial tumour resection*, chemotherapy
and/or radiotherapy, active surveillance (*wait-and-see*)
- Children must be able to undergo MRI without anaesthesia;
- Informed and having given informed consent (either by patient and / or
parents / legal guardian).

Exclusion Criteria

- The presence of claustrophobia;
- Patients from who it is expected at the time of inclusion that they will
undergo gross/near tumour resection (i.e. < 1 cc residual tumour) within 1
month;
- MRI-specific exclusion criteria, such as metal implants. Screening for MRI
specific exclusion criteria will be done using the regular MRI (at 7 Tesla)
safety screening. The screening form is attached to this proposal (F1);
- Refusal or inability to provide informed consent by patient and / or parent /
legal guardian.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Quantified levels of phospholipid metabolites and amide proteins in the tumour<br /><br>compared to healthy brain tissue.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Change in phospholipid levels in response to treatment, assessed by 31P- MRSI;<br /><br>- Change in amide protein levels in response to treatment, assessed by APT-CEST;<br /><br>- pH levels of the tissue;<br /><br>- Change in tumour volume: measured on conventional imaging according to RECIST<br /><br>criteria.</p><br>