Malignant Central Nervous System NeoplasmNCT04296617
Brain Imaging Changes Following Proton Therapy for Pediatric Primary Central Nervous System and Base of Skull Tumors
An observational study of Malignant Central Nervous System Neoplasm and Malignant Skull Base Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Malignant Central Nervous System Neoplasm, Malignant Skull Base Neoplasm
- What is being tested?
- Medical Chart Review
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2019to 23 Oct 2023
- Phase
- Observational
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients who are diagnosed with central nervous system or base of skull malignancies, undergoing proton beam therapy
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Being tested
- Medical Chart Review
- 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.
Medical Chart ReviewOther
Also called Chart Review
Review of medical chart
| Study group | Role | What they receive |
|---|---|---|
| Observational (medical chart review) | Patients' medical charts are reviewed. Receives: Other: Medical Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
White matter changes within the central nervous system (CNS) following proton beam therapy using magnetic resonance imaging (MRI) sequences
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.
Measured: At 18 months
White matter changes within the CNS following proton beam therapy using diffusion tensor imaging (DTI) sequences
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.
Measured: At 18 months
Relative biological effectiveness (RBE) predictions
Will compare concordance over time to evaluate if there is an increase, utilizing repeated measures mixtures models.
Measured: Up to 18 months
Secondary outcomes (3)
White matter changes within the CNS following proton beam therapy using DTI and MRI
Will assess the white matter changes within the CNS following proton beam therapy using DTI and MRI and determine concordance with predicted RBE values and biological dose.
Measured: Up to 18 months
Dose-volume effect and predicted LET distribution
Will be correlated. Will evaluate the percent of concordance of isodose volumes with white matter changes utilizing pairwise t-tests and repeated measures mixed models.
Measured: Up to 18 months
White matter changes identified on imaging, and predict concordance
Will be described with both clinical acute and late toxicities following proton beam therapy. Exploratory analyses utilizing tests for association and appropriate regression techniques will be conducted to determine the association of dose volume histogram, LET, RBE, and clinical factors on acute and late toxicities caused by white matter changes.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start21 Jan 2019
- Primary completion23 Oct 2023
- Study completion23 Oct 2023
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 Mayo ClinicThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamara Z. Vern-Gross, D.O., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296617
- Sponsor's protocol ID
- MC1777
- Other IDs
- NCI-2020-01197, 18-002279
- Status last verified
- May 2024
- First submitted
- 4 Mar 2020
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04296617
- Acronym / sponsor ID
- MC1777
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 23 Oct 2023 (actual)
- First posted
- 5 Mar 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 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:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (medical chart review) | – | Other: Medical Chart ReviewPatients' medical charts are reviewed. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients who are diagnosed with central nervous system or base of skull malignancies, undergoing proton beam therapy
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Medical Chart ReviewAlso: Chart ReviewReview of medical chart | Other | Observational (medical chart review) |
Primary outcome
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.
3 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
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 17 May 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Tamara Z. Vern-Gross, D.O. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Central Nervous System Neoplasm and Malignant Skull Base Neoplasm, run by Mayo Clinic at 1 site 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 2 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 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 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 17 May 2024.