Malignant Central Nervous System NeoplasmNCT04276194
Vertebral Body Sparing Craniospinal Irradiation for Pediatric Patients With Cancer of the Central Nervous System
A study testing Intensity-Modulated Proton Therapy and Magnetic Resonance Imaging in people with Malignant Central Nervous System Neoplasm, run by Emory University at 2 sites in United States.
Trial summary
This trial studies the feasibility of using intensity modulated proton therapy to deliver craniospinal irradiation while avoiding the bones of the vertebral column. Intensity modulated proton therapy is an advanced radiation therapy modality that uses high energy protons to kill cancer cells and shrink tumors, and may… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Malignant Central Nervous System Neoplasm
- What is being tested?
- Intensity-Modulated Proton Therapy and Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Dec 2019to 9 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pathologic diagnosis of central nervous system malignancy requiring craniospinal irradiation.
- Signed informed consent and assent when indicated.
Who cannot join
- Any contraindication to undergoing MRI (ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial cardiac valves or devices, electrical implants such as cardiac pacemakers or perfusion pumps). Metal fragments, shrapnel, or tattoos near the eye.
- Any major uncontrolled or poorly controlled current illness that would limit compliance with study requirements.
- Pregnant females are excluded. Females of childbearing age/menstruating must confirm that either they are not sexually active or have a negative pregnancy test prior to initiation of radiation therapy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory Proton Therapy Center
Atlanta, Georgia, 30308
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
About this study
Official title: Feasibility of Vertebral Body Sparing Intensity Modulated Proton Therapy Craniospinal Irradiation With in Vivo Range Verification in Growing Children
This trial studies the feasibility of using intensity modulated proton therapy to deliver craniospinal irradiation while avoiding the bones of the vertebral column. Intensity modulated proton therapy is an advanced radiation therapy modality that uses high energy protons to kill cancer cells and shrink tumors, and may reduce the side effects of treatment by reducing radiation exposure to the spinal column.
Read the detailed description
PRIMARY OBJECTIVES:
- To demonstrate the feasibility and safety of using intensity modulated proton therapy to deliver vertebral body sparing craniospinal irradiation in growing children.
Ia. To report the dose received to the vertebral bodies and the dose gradient/heterogeneity within the vertebral body.
Ib. To document, using weekly cone beam computed tomography (CT) of the cervical and lumbar spine, delivered dose in comparison with planned dose after accounting for any errors in patient positioning.
II. To evaluate acute toxicity of vertebral body sparing (VBS) craniospinal irradiation (CSI).
IIa. To report absolute lymphocyte counts over time and occurrence of grade 3-4 hematological toxicity.
IIb. To report the incidence and severity of any grade esophagitis during or within 4 weeks of radiation therapy.
III. To evaluate the feasibility of magnetic resonance imaging (MRI) imaging during CSI therapy as in vivo proton range verification.
IIIa. To demonstrate the feasibility of completing interim non-contrast MRIs of the spine during treatment.
IIIb. To characterize the earliest time point at which radiation induced bone marrow changes can be detected in children receiving proton CSI.
OUTLINE:
Patients undergo intensity modulated proton therapy once daily over 30 fractions and also undergo MRI over 20 minutes during fractions 7, 13, 20, and 30 of radiation in the absence of disease progression or unacceptable toxicity.
After the completion of study treatment, patients are followed up at 4 weeks and then every 3-12 months thereafter.
- Being tested
- Intensity-Modulated Proton Therapy, Magnetic Resonance Imaging
- Keywords
- Craniospinal, Proton Therapy, Pediatric
- Medical subject headings
- Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity-Modulated Proton TherapyProcedure or surgery
Also called IMPT
Undergo intensity modulated proton therapy
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI
Undergo MRI
| Study group | Role | What they receive |
|---|---|---|
| Treatment (intensity modulated proton therapy) | Experimental | Patients undergo intensity modulated proton therapy once daily over 30 fractions and also undergo MRI over 20 minutes during fractions 7, 13, 20, and 30 of radiation in the absence of disease progression or unacceptable toxicity. Receives: Procedure: Intensity-Modulated Proton Therapy; Procedure: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of acute hematologic toxicity
Will be graded according to Common Terminology Criteria for Adverse Events version 5.0.
Measured: Up to 2 years
Dose delivered to vertebral bodies and quality assurance of treatment plans
Multiple measurements will be aggregated to arrive at one reported value when toxicities are graded (1-5). Dose statistics are in units of Gy or may be %
Measured: Up to 2 years
Bone marrow changes on MRI
Will be quantitatively and qualitatively analyzed in relationship to the proton dose distribution
Measured: At baseline, and fractions 7, 13, 20, and 30 of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start16 Dec 2019
- Primary completion3 Nov 2021
- Study completion9 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Central Nervous System NeoplasmStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Bree Eaton, Emory University
- Investigators
- Bree R Eaton, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276194
- Sponsor's protocol ID
- IRB00113121
- Other IDs
- NCI-2019-05118, P30CA138292, RAD4737-19
- Status last verified
- Mar 2024
- First submitted
- 27 Jan 2020
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Vertebral Body Sparing Intensity Modulated Proton Therapy Craniospinal Irradiation With in Vivo Range Verification in Growing Children
- ClinicalTrials.gov ID
- NCT04276194
- Acronym / sponsor ID
- IRB00113121
- Keywords
- Craniospinal, Proton Therapy, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 3 Nov 2021 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial studies the feasibility of using intensity modulated proton therapy to deliver craniospinal irradiation while avoiding the bones of the vertebral column. Intensity modulated proton therapy is an advanced radiation therapy modality that uses high energy protons to kill cancer cells and shrink tumors, and may reduce the side effects of treatment by reducing radiation exposure to the spinal column.
Detailed description
PRIMARY OBJECTIVES:
- To demonstrate the feasibility and safety of using intensity modulated proton therapy to deliver vertebral body sparing craniospinal irradiation in growing children.
Ia. To report the dose received to the vertebral bodies and the dose gradient/heterogeneity within the vertebral body.
Ib. To document, using weekly cone beam computed tomography (CT) of the cervical and lumbar spine, delivered dose in comparison with planned dose after accounting for any errors in patient positioning.
II. To evaluate acute toxicity of vertebral body sparing (VBS) craniospinal irradiation (CSI).
IIa. To report absolute lymphocyte counts over time and occurrence of grade 3-4 hematological toxicity.
IIb. To report the incidence and severity of any grade esophagitis during or within 4 weeks of radiation therapy.
III. To evaluate the feasibility of magnetic resonance imaging (MRI) imaging during CSI therapy as in vivo proton range verification.
IIIa. To demonstrate the feasibility of completing interim non-contrast MRIs of the spine during treatment.
IIIb. To characterize the earliest time point at which radiation induced bone marrow changes can be detected in children receiving proton CSI.
OUTLINE:
Patients undergo intensity modulated proton therapy once daily over 30 fractions and also undergo MRI over 20 minutes during fractions 7, 13, 20, and 30 of radiation in the absence of disease progression or unacceptable toxicity.
After the completion of study treatment, patients are followed up at 4 weeks and then every 3-12 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (intensity modulated proton therapy) | Experimental | Procedure: Intensity-Modulated Proton Therapy, Procedure: Magnetic Resonance ImagingPatients undergo intensity modulated proton therapy once daily over 30 fractions and also undergo MRI over 20 minutes during fractions 7, 13, 20, and 30 of radiation in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Pathologic diagnosis of central nervous system malignancy requiring craniospinal irradiation.
- Signed informed consent and assent when indicated.
Key exclusion criteria (3 listed)
- Any contraindication to undergoing MRI (ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial cardiac valves or devices, electrical implants such as cardiac pacemakers or perfusion pumps). Metal fragments, shrapnel, or tattoos near the eye.
- Any major uncontrolled or poorly controlled current illness that would limit compliance with study requirements.
- Pregnant females are excluded. Females of childbearing age/menstruating must confirm that either they are not sexually active or have a negative pregnancy test prior to initiation of radiation therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensity-Modulated Proton TherapyAlso: IMPTUndergo intensity modulated proton therapy | Procedure or surgery | Treatment (intensity modulated proton therapy) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRIUndergo MRI | Procedure or surgery | Treatment (intensity modulated proton therapy) |
Primary outcome
Incidence and severity of acute hematologic toxicity
Time frame: Up to 2 years
Will be graded according to Common Terminology Criteria for Adverse Events version 5.0.
Dose delivered to vertebral bodies and quality assurance of treatment plans
Time frame: Up to 2 years
Multiple measurements will be aggregated to arrive at one reported value when toxicities are graded (1-5). Dose statistics are in units of Gy or may be %
Bone marrow changes on MRI
Time frame: At baseline, and fractions 7, 13, 20, and 30 of radiation therapy
Will be quantitatively and qualitatively analyzed in relationship to the proton dose distribution
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bree R Eaton principal investigator
Emory University Hospital/Winship Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensity-Modulated Proton Therapy and Magnetic Resonance Imaging in people with Malignant Central Nervous System Neoplasm, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of acute hematologic toxicity (time frame: Up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.