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Observational Trial of the Impact of Radiation Dose in Children With Brain and Skull Base Tumors.

StatusActive, Not Recruiting
PhaseNot specified
Started2019-03-08
View on ClinicalTrials.gov ↗

Amendment history

2026-07-13
3 amendments v8-v10
3 re-verifications since 2024-07-09, no change to tracked fields
2023-07-07
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v7
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2022-07-07
4 amendments v3-v6
4 re-verifications since 2021-01-12, no change to tracked fields
2020-07-29
Study Status, Sponsor/Collaborators, IPDSharing v2
Collaborators+60 characters
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
2019-11-15
Study Status, Eligibility, Contacts/Locations v1
Eligibility criteria-23 characters
[...] en assent will be obtained as per Institutional guidelines. ChildrenPatients (Age 1-21equal to or less than 35 years old) whothat are planned to receive photon or proton RT to the brain withaccording curativeto intentstandard of care are eligible to participate. AllPatients that are planned to receive fractionated RT at 1.2-2.0 Gy RBE dose per fraction per standard of care are eligible to participate. If patients must undergo CT simulation and MRI WWO contrast for target volume delineation and brain substructure segmentation. CT simulation and MRI are performedplanned to receive an alternative [...] [...]
Study sitescontacts updated at 1 of 1 site
2019-05-31
Original filing
This is a prospective, observational clinical trial investigating the morphological and volumetric changes in the brain following cranial Radiation Therapy in pediatric patients with brain or skull base tumors.
Trial Details
NCT Number NCT03972514
Lead Sponsor Baptist Health South Florida
Collaborators: Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Conditions Brain Tumor, Brain Cancer, Skull Base Tumor
Enrollment 60 participants
Start Date 2019-03-08
Primary Completion 2030-03 (estimated)
Study Completion 2030-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-14