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

NCT06226519 | Unknown

• 1 other identifier: PET/RMN
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Brain Tumor

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

11C-MET-PET/RMN DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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 at least 6 months will undergo a brain MET-PET/MRI.

You may qualify if:

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

You may not qualify if:

• patients \>18 years

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Irccs San Raffaele

Milan, Italy

RECRUITING

Central Study Contacts

Arturo Chiti

CONTACT

0226432716; chiti.arturo@hsr.it

Alessandra Maielli

CONTACT

0226433639; maielli.alessandra@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Diagnostic Imaging and Radiotherapy Faculty of Medicine and Surgery, Vita-Salute San Raffaele University Director, Department of Nuclear Medicine, IRCCS Ospedale San Raffaele

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 26, 2024
• Study Start: May 13, 2020
• Primary Completion: May 13, 2024
• Study Completion: May 13, 2024
• Last Updated: January 26, 2024

Record last verified: 2024-01

Locations

IT (1)