Pediatric Brain Tumor Clinical Trial
Official title:
Integrated PET/MRI and Germline Variants to Differentiate Brain Tumopr Recurrence From Iatrogenicchanges in Children
| 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 |
| Verified date | January 2024 |
| Source | IRCCS San Raffaele |
| Contact | Arturo Chiti |
| Phone | 0226432716 |
| chiti.arturo[@]hsr.it | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Irccs San Raffaele | Milano |
| Lead Sponsor | Collaborator |
|---|---|
| IRCCS San Raffaele |
Italy,
| 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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