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

NCT03972514 | Active Not Recruiting

• 1 other identifier: 2018-LLB-HALL-001
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Tumor; Brain Cancer; Skull Base Tumor

Keywords

brain; pediatrics brain cancer; pediatrics; skull

Outcome Measures

Primary Outcomes (2)

• Measure temporal changes in brain volumes

  Measure temporal changes in brain volumes after exposure to therapeutic RT and to correlate these changes with absorbed dose.

  Baseline, 6 Months, 12 months, 18 months, 24 months and 3-5 years

• Measure temporal changes in morphometry

  Measure temporal changes in morphometry after exposure to therapeutic RT and to correlate these changes with absorbed dose.

  Baseline, 6 Months, 12 months, 18 months, 24 months and 3-5 years

Secondary Outcomes (1)

• Morphometric changes in the brain

  Baseline, 6 Months, 12 months, 18 months, 24 months and 3-5 years

Other Outcomes (1)

• Measure molecular biomarkers

  Baseline, 6 Months, 12 months, 18 months, 24 months and 3-5 years

Eligibility Criteria

• Age: 1 Year - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study sample size will be 60 patients. This sample size was selected to ensure an adequate distribution of primary tumor diagnoses and dosimetric variation in major brain substructures treated based on tumor location/brain regions treated. The estimated case distribution based on historical data from 2007-2015 will be: Craniopharyngioma 20%, Ependymoma 20%, Low Grade Glioma 20%, Medulloblastoma/PNET 15%, Sarcoma 10%, Other 15%.

You may qualify if:

• Patient (parent) must give study-specific informed consent on an IRB-approved consent prior to any research related procedures or study treatment. Written assent will be obtained as per Institutional guidelines.
• Patients (Age equal to or less than 35 years old) that are planned to receive photon or proton RT to the brain according to standard of care are eligible to participate.
• Patients 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 are planned to receive an alternative dose/fractionation regimen, then they should be treated according to standard of care and should not be enrolled.
• Zubrod/Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1

You may not qualify if:

• Patient cannot undergo MRI without contrast as per standard of care
• Patient and family do not speak English or Spanish
• Patient receiving treatment with non-curative intent
• Patients with an expected 3-year overall survival less than 50%

Sponsors & Collaborators

• Baptist Health South Florida: lead
• Nicklaus Children's Hospital f/k/a Miami Children's Hospital: collaborator

Study Sites (1)

Miami Cancer Institute at Baptist Health South Florida

Miami, Florida, 33176, United States

Location

Related Links

• Miami Cancer Institute Website

MeSH Terms

Conditions

Brain Neoplasms; Skull Base Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skull Neoplasms; Bone Neoplasms; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Matthew D Hall, MD

  Miami Cancer Institute (MCI) at Baptist Health South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: June 3, 2019
• Study Start: March 8, 2019
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

US (1)