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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 : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Baptist Health South Florida

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.

Condition or disease
Brain Tumor Brain Cancer Skull Base Tumor

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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Actual Study Start Date : March 8, 2019
Estimated Primary Completion Date : March 2030
Estimated Study Completion Date : March 2030



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%.
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.
  • Children (Age 1-21 years old) who receive photon or proton RT to the brain with curative intent
  • All patients must undergo CT simulation and MRI WWO contrast for target volume delineation and brain substructure segmentation. CT simulation and MRI are performed according to standard of care and patients would be scheduled for these scans whether or not they participate in this trial
  • All patients must receive fractionated RT at doses of 1.5-2.0 Gy RBE per fraction
  • Zubrod Performance Status ≥70

Exclusion Criteria:

  • Patient cannot undergo MRI with contrast
  • Presence of distant metastatic disease on CT/MRI
  • Patient and family do not speak English or Spanish
  • Patient receiving treatment with non-curative intent or with an expected 3-year overall survival less than 50%
  • Patient receiving RT at doses >2.0 Gy RBE per fraction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03972514


Contacts
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Contact: Matthew D Hall, MD (786) 527-8140 MatthewHa@BaptistHealth.net
Contact: Miguel A Villalona-Calero, MD 786-596-2000 MiguelVil@baptisthealth.net

Locations
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United States, Florida
Miami Cancer Institute at Baptist Health South Florida Recruiting
Miami, Florida, United States, 33176
Contact: Miguel A Villalona-Calero, MD    786-527-8028    MiguelVil@baptisthealth.net   
Principal Investigator: Matthew D Hall, MD         
Sponsors and Collaborators
Baptist Health South Florida
Investigators
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Principal Investigator: Matthew D Hall, MD Miami Cancer Institute (MCI) at Baptist Health South Florida

Additional Information:
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Responsible Party: Baptist Health South Florida
ClinicalTrials.gov Identifier: NCT03972514     History of Changes
Other Study ID Numbers: 2018-LLB-HALL-001
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Baptist Health South Florida:
brain
pediatrics brain cancer
pediatrics
skull

Additional relevant MeSH terms:
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Neoplasms
Brain Neoplasms
Skull Base Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Skull Neoplasms
Bone Neoplasms
Bone Diseases
Musculoskeletal Diseases