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

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ClinicalTrials.gov Identifier: NCT03972514
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : July 15, 2021
Sponsor:
Collaborator:
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Information provided by (Responsible Party):
Baptist Health South Florida

Tracking Information
First Submitted Date April 25, 2019
First Posted Date June 3, 2019
Last Update Posted Date July 15, 2021
Actual Study Start Date March 8, 2019
Estimated Primary Completion Date March 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 31, 2019)
  • Measure temporal changes in brain volumes [ Time Frame: Baseline, 6 Months, 12 months, 18 months, 24 months and 3-5 years ]
    Measure temporal changes in brain volumes after exposure to therapeutic RT and to correlate these changes with absorbed dose.
  • Measure temporal changes in morphometry [ Time Frame: Baseline, 6 Months, 12 months, 18 months, 24 months and 3-5 years ]
    Measure temporal changes in morphometry after exposure to therapeutic RT and to correlate these changes with absorbed dose.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 31, 2019)
Morphometric changes in the brain [ Time Frame: Baseline, 6 Months, 12 months, 18 months, 24 months and 3-5 years ]
The secondary aims for this study are to correlate morphometric changes in the brain with the development of late treatment-related effects, including measurable neurocognitive, endocrine, and quality of life effects.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 31, 2019)
Measure molecular biomarkers [ Time Frame: Baseline, 6 Months, 12 months, 18 months, 24 months and 3-5 years ]
Serum pro-inflammatory and anti-inflammatory cytokine levels will be measured at baseline and during follow-up as part of an exploratory hypothesis-generating correlate study to analyze potential associations with risk of radiation-induced toxicities and volumetric changes in the brain.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Observational Trial of the Impact of Radiation Dose in Children With Brain and Skull Base Tumors.
Official Title Prospective Observational Trial of the Impact of Radiation Dose on Brain Morphology, Volumetric Changes, Endocrine Function, and Neurocognitive Function Following Cranial Radiation Therapy in Children With Brain and Skull Base Tumors.
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.
Detailed Description

Brain injury is a known complication of cranial RT, but little is known about the factors that predispose patients to such injury. The brain is a highly interconnected organ linked through neuronal connections, cellular migration, and vascular supply and is endowed with exquisitely radiosensitive stem cell niches responsible for neuro-regeneration. To date, the effects of brain radiation have been quantified in few brain substructures. The majority of publications on this topic have focused on regions receiving higher doses. Even low dose radiation exposure, however has global implications on brain development and function, and its effects are less well studied. It is increasingly recognized that radiation damage to one brain region can potentially affect brain development more broadly. This has important implications on RT planning and the potential for understanding its long-term effects.

In this protocol, the investigators aim to measure serum inflammatory cytokine levels and other molecular biomarkers at baseline and post-exposure in an exploratory manner to investigate potential associations with the risk of developing volumetric changes in the brain and radiation-induced toxicities.

This study will observe sixty (60) patients under the age of 21 with brain or base of skull tumor. The study team will observe the effect of radiation therapy per the study protocol versus standard of care.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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%.
Condition
  • Brain Tumor
  • Brain Cancer
  • Skull Base Tumor
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 31, 2019)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2030
Estimated Primary Completion Date March 2030   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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%
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 35 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Matthew D Hall, MD (786) 527-8140 MatthewHa@BaptistHealth.net
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03972514
Other Study ID Numbers 2018-LLB-HALL-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Baptist Health South Florida
Study Sponsor Baptist Health South Florida
Collaborators Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Investigators
Principal Investigator: Matthew D Hall, MD Miami Cancer Institute (MCI) at Baptist Health South Florida
PRS Account Baptist Health South Florida
Verification Date June 2021