Integrated PET/MRI and Germline Variants to Differentiate Brain Tumopr Recurrence From Iatrogenicchanges in Children

Recruiting

• Conditions: Pediatric Brain Tumor

• Registration Number: NCT06226519
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

Nuclear magnetic resonance imaging (NMR) is used in pediatric brain tumors for purposes of diagnosis, evaluation of response to treatments, and monitoring of patients in follow-up. Through conventional imaging techniques it remains difficult to differentiate tumor recurrence from pseudo-progression or other iatrogenic changes after radiotherapy or chemotherapy, but it remains a relevant and essential clinical need for patient management.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-13
• Status Verified: 2024-01
• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-23
• Last Update Submitted: 2024-01-23
• Study First Posted: 2024-01-26
• Last Update Posted: 2024-01-26
• Primary Completion: 2024-05-13
• Study Completion: 2024-05-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• children and/or adolescents (≤18 years) diagnosed with brain tumor.
• children who underwent the contemporary adjuvant therapy protocol of post-surgical chemo and radiotherapy.

Exclusion Criteria

• patients >18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MET-PET/brain MRI in children with brain tumor for diagnosis of brain tumor recurrence compared to therapy-induced changes.	4 years	The role of MET-PET/MRI and radiogenomics could play in the follow-up management of children and adolescents with brain tumors and in ensuring timely intervention in case of tumor recurrence/progression.

Trial Locations

Locations (1)

Irccs San Raffaele; 🇮🇹 Milano, Italy