---
title: Brain Imaging Changes Following Proton Therapy for Pediatric Primary Central Nervous System and Base of Skull Tumors
nct_id: NCT04296617
overall_status: COMPLETED
sponsor: Mayo Clinic
study_type: OBSERVATIONAL
primary_condition: Malignant Central Nervous System Neoplasm
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04296617.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04296617"
ct_last_update_post_date: 2024-05-17
last_seen_at: "2026-05-12T06:02:26.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Brain Imaging Changes Following Proton Therapy for Pediatric Primary Central Nervous System and Base of Skull Tumors

**Official Title:** Assessment of Predicted LET and Dosimetry in Relation to White Matter Changes in Pediatric Patients Following Proton Therapy for Primary Central Nervous System and Base of Skull Malignancies: A Pilot Study

**NCT ID:** [NCT04296617](https://clinicaltrials.gov/study/NCT04296617)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 36
- **Lead Sponsor:** Mayo Clinic
- **Conditions:** Malignant Central Nervous System Neoplasm, Malignant Skull Base Neoplasm
- **Start Date:** 2019-01-21
- **Completion Date:** 2023-10-23
- **CT.gov Last Update:** 2024-05-17

## Brief Summary

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.

## Detailed Description

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.

## Eligibility

- **Maximum age:** 21 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Observational (medical chart review)** — Patients' medical charts are reviewed.

## Interventions

- **Medical Chart Review** (OTHER) — Review of medical chart

## Primary Outcomes

- **White matter changes within the central nervous system (CNS) following proton beam therapy using magnetic resonance imaging (MRI) sequences** _(time frame: At 18 months)_ — The concordance of predicted linear energy transfer linear (LET) values with radiographic white matter changes will be analyzed utilizing a one sample t-test. Will the compare concordance over time to evaluate if there is an increase, utilizing repeated measures mixtures models.
- **White matter changes within the CNS following proton beam therapy using diffusion tensor imaging (DTI) sequences** _(time frame: At 18 months)_ — The concordance of predicted LET values with radiographic white matter changes will be analyzed utilizing a one sample t-test. We will the compare concordance over time to evaluate if there is an increase, utilizing repeated measures mixtures models.
- **Relative biological effectiveness (RBE) predictions** _(time frame: Up to 18 months)_ — Will compare concordance over time to evaluate if there is an increase, utilizing repeated measures mixtures models.

## Secondary Outcomes

- **White matter changes within the CNS following proton beam therapy using DTI and MRI** _(time frame: Up to 18 months)_
- **Dose-volume effect and predicted LET distribution** _(time frame: Up to 18 months)_
- **White matter changes identified on imaging, and predict concordance** _(time frame: Up to 18 months)_

## Locations (1)

- Mayo Clinic in Arizona, Scottsdale, Arizona, United States

## Recent Field Changes (last 30 days)

- `eligibility.sex` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.mayo clinic in arizona|scottsdale|arizona|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04296617.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04296617*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*