Proton Therapy for Pediatric Brain Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Bree R. Eaton, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Emory University

Disqualifiers: Pacemakers, Cochlear implants, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial studies how well spectroscopic magnetic resonance imaging (MRI) guided proton therapy works in assessing metabolic change in pediatric patients with brain tumors. The non-invasive imaging, such as spectroscopic MRI may help to map the differences in tumor metabolism compared to healthy tissue without injection of any contrast agent.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Proton Therapy for Pediatric Brain Cancer?

Research shows that proton therapy, including intensity-modulated proton therapy (IMPT), provides better dose distribution and reduces side effects compared to traditional photon therapy for pediatric brain tumors. This means it can target the tumor more precisely while sparing healthy brain tissue, which is especially important for children.

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Is proton therapy safe for children with brain cancer?

Proton therapy is generally considered safe for children with brain cancer, as it can reduce side effects by targeting tumors more precisely than traditional radiation. However, there is limited information on acute side effects, and ongoing studies aim to better understand these risks.

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How is proton therapy different from other treatments for pediatric brain cancer?

Proton therapy is unique because it uses protons instead of traditional X-rays to target brain tumors, allowing for more precise delivery of radiation that spares healthy brain tissue. This can reduce side effects and is especially beneficial for children, whose brains are still developing.

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Eligibility Criteria

This trial is for children with high-grade brain tumors (WHO grade 3-4) who are recommended to receive radiation therapy and can undergo MRI scans. It's open to all genders, races, and ethnic groups. The tumor must be in the upper part of the brain. Kids with significant illnesses that make MRI unsafe or have certain implants like pacemakers are not eligible.

Inclusion Criteria

My brain tumor is confirmed or suspected to be high-grade.

My brain tumor is located above the cerebellum.

Able to receive MRI scans

Exclusion Criteria

My brain tumor is non-cancerous and low-grade.

Patients with pacemakers, non-titanium aneurysm clips, neurostimulators, cochlear implants, non-titanium metal in ocular structures, or other incompatible implants which makes MRI safety an issue are excluded

Patients that have any significant medical illnesses that in the investigator's opinion cannot be adequately tolerate MRI scan are excluded

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment Imaging

Patients undergo spectroscopic MRI (sMRI) to obtain baseline data before receiving standard of care radiation therapy

1 week

1 visit (in-person)

Radiation Therapy

Patients receive standard of care radiation therapy guided by sMRI data

10 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with sMRI scans at 1, 4, and 7 months post-radiation therapy

7 months

3-4 visits (in-person)

Participant Groups

The study is testing how well a special type of MRI called spectroscopic imaging works alongside proton therapy to see changes in the metabolism of brain tumors in kids without using contrast agents. This non-invasive method could help distinguish between healthy tissue and tumor metabolism.

Group I: Diagnostic (sMRI) Experimental Treatment 2 Interventions

Patients undergo sMRI over less than 1 hour within 7 days prior to start of standard of care radiation therapy and at 10 weeks.

Group II: Group 2 Active Control 2 Interventions

Patients will undergo 3-4 sMRI scans at baseline prior to RT, 1 month, 4 months, and 7 months after RT, and/or at any time of suspected tumor recurrence.

Proton Therapy is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Proton Therapy for:

• Head and neck cancer
• Pediatric cancers
• Spine tumors
• Breast cancer
• Sarcoma
• Brain tumors
• Prostate cancer

🇪🇺 Approved in European Union as Proton Therapy for:

• Head and neck cancer
• Pediatric cancers
• Spine tumors
• Breast cancer
• Sarcoma
• Brain tumors
• Prostate cancer

🇨🇦 Approved in Canada as Proton Therapy for:

• Head and neck cancer
• Pediatric cancers
• Spine tumors
• Breast cancer
• Sarcoma
• Brain tumors
• Prostate cancer

🇯🇵 Approved in Japan as Proton Therapy for:

• Head and neck cancer
• Pediatric cancers
• Spine tumors
• Breast cancer
• Sarcoma
• Brain tumors
• Prostate cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Emory Proton Therapy Center Atlanta, GA

Children's Healthcare of Atlanta - Scottish Rite Atlanta, GA

Emory University Hospital/Winship Cancer Institute Atlanta, GA

Who Is Running the Clinical Trial?

Emory University Lead Sponsor

National Cancer Institute (NCI) Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

Proton radiotherapy for pediatric central nervous system germ cell tumors: early clinical outcomes. [2022] To report early clinical outcomes for children with central nervous system (CNS) germ cell tumors treated with protons; to compare dose distributions for intensity-modulated photon radiotherapy (IMRT), three-dimensional conformal proton radiation (3D-CPT), and intensity-modulated proton therapy with pencil beam scanning (IMPT) for whole-ventricular irradiation with and without an involved-field boost.

2. Switzerland pubmed.ncbi.nlm.nih.gov

Influence of Target Location, Size, and Patient Age on Normal Tissue Sparing- Proton and Photon Therapy in Paediatric Brain Tumour Patient-Specific Approach. [2020] Proton radiotherapy produces superior dose distributions compared to photon radiotherapy, reducing side effects. Differences between the two modalities are not fully quantified in paediatric patients for various intracranial tumour sites or age. Understanding these differences may help clinicians estimate the benefit and improve referral across available centres. Our aim was to compare intensity-modulated proton therapy (IMPT) and intensity-modulated photon radiotherapy (IMRT) radiation doses for select paediatric intracranial tumours.

3. United States pubmed.ncbi.nlm.nih.gov

Radiation Therapy for Pediatric Brain Tumors using Robotic Radiation Delivery System and Intensity Modulated Proton Therapy. [2020] This study recruited 2 centers with expertise in treating pediatric brain tumors with robotic radiation delivery system photon therapy and proton therapy, respectively, to study the plan quality and dose deposition characteristics of robotic radiation delivery system photon therapy and intensity modulated proton therapy (IMPT) plans.

4. England pubmed.ncbi.nlm.nih.gov

The effectiveness and safety of proton beam radiation therapy in children with malignant central nervous system (CNS) tumours: protocol for a systematic review. [2023] The aim of this study is to use a systematic review framework to identify and synthesise the evidence on the use of proton beam therapy (PBT) for the treatment of children with CNS tumours and where possible compare this to the use of photon radiotherapy (RT).

5. England pubmed.ncbi.nlm.nih.gov

A comparative study of dose distribution of PBT, 3D-CRT and IMRT for pediatric brain tumors. [2018] It was reported that proton beam therapy (PBT) reduced the normal brain dose compared with X-ray therapy for pediatric brain tumors. We considered whether there was not the condition that PBT was more disadvantageous than intensity modulated photon radiotherapy (IMRT) and 3D conventional radiotherapy (3D-CRT) for treatment of pediatric brain tumors about the dose reduction for the normal brain when the tumor location or tumor size were different.

6. United States pubmed.ncbi.nlm.nih.gov

Factors Associated With Acute Toxicity in Pediatric Patients Treated With Proton Radiation Therapy: A Report From the Pediatric Proton Consortium Registry. [2022] Limited prospective information regarding acute toxicity in pediatric patients receiving proton therapy (PT) exists. In this study, Pediatric Proton Consortium Registry (PPCR) data was analyzed for factors associated with development of acute toxicity in children receiving passively scattered or pencil beam scanning PT.

7. United States pubmed.ncbi.nlm.nih.gov

Proton radiation therapy for head and neck cancer. [2018] Due to the close spatial relationship of head and neck and skull base tumors to numerous normal anatomical structures, conventional photon radiation therapy can be associated with significant acute and long-term treatment-related toxicities. Superior dose localization properties of proton radiation therapy allow smaller volumes of normal tissues to be irradiated than is feasible with any photon technique. Intensity-modulated proton therapy (IMPT) is a powerful delivery technique which results in improved dose distribution as compared to that of intensity-modulated radiation therapy (IMRT). Initial clinical experience with proton radiation therapy in treatment of head and neck and skull base tumors is promising. Prospective multi-institutional trials are underway to define the role of proton radiation therapy, particularly IMPT, in the treatment of head and neck and skull base tumors.

8. United States pubmed.ncbi.nlm.nih.gov

Mixed Effect Modeling of Dose and Linear Energy Transfer Correlations With Brain Image Changes After Intensity Modulated Proton Therapy for Skull Base Head and Neck Cancer. [2022] Intensity modulated proton therapy (IMPT) could yield high linear energy transfer (LET) in critical structures and increased biological effect. For head and neck cancers at the skull base this could potentially result in radiation-associated brain image change (RAIC). The purpose of the current study was to investigate voxel-wise dose and LET correlations with RAIC after IMPT.

9. England pubmed.ncbi.nlm.nih.gov

Feasibility of Proton Beam Therapy for Infants with Brain Tumours: Experiences from the Prospective KiProReg Registry Study. [2021] Proton beam therapy (PBT) has increasingly been applied for the treatment of young children when radiotherapy is needed. The treatment requires intensive multimodality care and is logistically demanding. In this analysis, we evaluated our experiences in treating infants with tumours of the central nervous system with PBT.

10. United States pubmed.ncbi.nlm.nih.gov

Preliminary Experience of Treating Children and Young Adults With Image-Guided Proton Beam Therapy in India. [2021] Proton beam therapy (PBT) has been a preferred modality in pediatric malignancies requiring radiotherapy. We report our preliminary experience of treating consecutive patients younger than 25 years with image-guided pencil beam scanning PBT from the first and only center on the Indian subcontinent.