Pediatric Brain Tumor Foundation
Working to eliminate the challenges of childhood brain tumors

Cure the kids! Give Now

Assessment of LET-Based Models and Changes Seen on Brain Imaging in Pediatric Patients Following Proton Therapy for Primary Central Nervous System or Base of Skull Tumors

Study Purpose

This trial gathers information from patients with primary central nervous system or base of skull tumors that receive proton beam therapy and see if certain imaging techniques can help detect radiation-related changes over time. This study may help providers learn more about proton beam radiotherapy and how to improve the way it is delivered.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A - 21 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients must have histologically confirmed central nervous system of skull base tumors.
  • - Patient is going to undergo central nervous system (CNS) or base of skull proton beam therapy.

Exclusion Criteria:

  • - Patients who have received prior therapeutic radiotherapy to the primary brain tumor site.
- Patients who are unable to maintain follow-up through the Phoenix Children's Hospital and Mayo Clinic Arizona

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04296617
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Mayo Clinic
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Tamara Z Vern-Gross
Principal Investigator Affiliation Mayo Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherNIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Malignant Central Nervous System Neoplasm, Malignant Skull Base Neoplasm
Additional Details

PRIMARY OBJECTIVE:

  • I. To establish linear energy transfer (LET)-based models as early predictors for white matter changes on magnetic resonance imaging (MRI) and diffusion tensor imaging (DTI) sequences in pediatric patients following proton beam therapy for primary central nervous system (CNS) and base of skull tumors.
OUTLINE: Patients' medical charts are reviewed.

Arms & Interventions

Arms

: Observational (medical chart review)

Patients' medical charts are reviewed.

Interventions

Other: - Medical Chart Review

Review of medical chart

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic in Arizona, Scottsdale, Arizona

Status

Recruiting

Address

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259

Site Contact

Clincial Trials Referral Office

mayocliniccancerstudies@mayo.edu

855-776-0015