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NCT06226519 Clinical Trial

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

Pediatric Brain Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06226519
Other study ID # PET/RMN
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 13, 2020
Est. completion date May 13, 2024

Study information
Verified date January 2024
Source IRCCS San Raffaele
Contact Arturo Chiti
Phone 0226432716
Email chiti.arturo@hsr.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date May 13, 2024
Est. primary completion date May 13, 2024
Accepts healthy volunteers
Gender All
Age group N/A to 18 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 11C-MET-PET/RMN
60 children and/or adolescents (=18 years) with a diagnosis of brain tumor (medulloblastoma, other embryonal tumors or high-grade gliomas), who have followed the contemporary adjuvant therapy protocol of post-surgical chemo and radiotherapy and completed radiotherapy for at least 6 months will undergo a brain MET-PET/MRI.

Locations
Country Name City State
Italy Irccs San Raffaele Milano

Sponsors (1)
Lead Sponsor Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary MET-PET/brain MRI in children with brain tumor for diagnosis of brain tumor recurrence compared to therapy-induced changes. 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. 4 years
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