Observational Trial of the Impact of Radiation Dose in Children With Brain and Skull Base Tumors.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03972514|
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : July 8, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease|
|Brain Tumor Brain Cancer Skull Base Tumor|
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|
|Estimated Enrollment :||60 participants|
|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|
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||1 Year to 35 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- 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
- 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%
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
|Contact: Matthew D Hall, MD||(786) 527-8140||MatthewHa@BaptistHealth.net|
|United States, Florida|
|Miami Cancer Institute at Baptist Health South Florida||Recruiting|
|Miami, Florida, United States, 33176|
|Contact: Matthew D Hall, MD 786-596-2000 MatthewHa@baptisthealth.net|
|Principal Investigator: Matthew D Hall, MD|
|Principal Investigator:||Matthew D Hall, MD||Miami Cancer Institute (MCI) at Baptist Health South Florida|
|Responsible Party:||Baptist Health South Florida|
|Other Study ID Numbers:||
|First Posted:||June 3, 2019 Key Record Dates|
|Last Update Posted:||July 8, 2022|
|Last Verified:||July 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
pediatrics brain cancer
Skull Base Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Nervous System Diseases