Brain TumorNCT03394716
Monitoring MRI Changes Before and During Radiotherapy Treatment of Brain Tumors
An observational study of Brain Tumor, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
This study aims to evaluate anatomical and functional changes during RT for patients receiving fractionated RT for brain tumors. Anatomical changes during RT will be registered and analyzed and if needed the radiotherapy plan will be modified for the individual patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Jan 2018to 10 Dec 2020
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastasis in the brain from extracranial solid tumors or patients with primary brain tumors who will be treated with fractionated radiotherapy.
Who may be able to join
- Primary brain tumor (WHO IV, GBM); treated with fractionated radiotherapy with or without preceding surgery. Systemic treatment is allowed before and during radiotherapy.
- Brain metastasis (from a solid extracranial tumor) eligible for treatment with fractionated radiotherapy with or without preceding surgery. Systemic treatment is allowed before and during radiotherapy.
- Also, postoperative patients with a macroscopic residual tumor lesion can be included (the diagnosis of residual diseases is defined by the treating neurosurgeon or on the MRI executed within 24 hours after the surgery, the diagnosis of residual macroscopic disease should always be confirmed during the neuro-oncology multidisciplinary meeting).
Who cannot join
- Patients receiving Whole Brain RT (WBRT)
- Patient with a poor kidney function (GFR < 30 mL/min; CKD 4 and 5; patients on dialysis and patients with acute kidney insufficiency)
- None, doubtful or very small (<5 mm in its largest dimension) contrast enhancing lesion
- Patients with a contraindication for MRI
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate anatomical and functional changes during RT for patients receiving fractionated RT for brain tumors. Anatomical changes during RT will be registered and analyzed and if needed the radiotherapy plan will be modified for the individual patient. This means that the "to be irradiated volume" will be modified according to the shape changes of the tumor. The functional MRI sequences will be used to evaluate what parameters, and at which time point, are important for radiotherapy outcome.
- Conditions
- Brain Tumor
- Being tested
- Radiotherapy
- Keywords
- MRI, Radiotherapy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
standard radiotherapy treatment with 1-3 extra MRIs
| Study group | Role | What they receive |
|---|---|---|
| Patient brain tumor treated with fractionated radiotherapy | Not described Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI parameters in the target volume
functional MRI parameters (permeability, perfusion and diffusion) in the target volume before and during fractional radiotherapy treatment
Measured: through study completion, an average of 3 years
anatomical variations in position, shape and size in the target volume
The difference is position shape and size in the target volume before and during fractional radiotherapy treatment. In case there is no macroscopic extension beyond the clinical target volume the new target volumes (gross target volume (GTV) and clinical target volume (CTV).) will also (but later) be delineated for analysis of volume changes, center of mass changes and distance measurements between the delineation on planning MRI versus repeated MRI.
Measured: through study completion, an average of 3 years
Secondary outcomes (2)
the correlation between MRI parameters to the treatment outcome
to make a sample size calculation for a future study of imaging marker discovery.
Measured: through study completion, an average of 3 years
the correlation between anatomical variations and the treatment outcome
to make a sample size calculation for a future study of imaging marker discovery.
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start12 Jan 2018
- Primary completion10 Dec 2020
- Study completion10 Dec 2020
Why it stopped: Low inclusion rate; Change of position of principal investigator.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394716
- Sponsor's protocol ID
- N17MRB
- Status last verified
- Apr 2021
- First submitted
- 28 Nov 2017
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring MRI Changes Before and During Radiotherapy Treatment of Brain Tumors
- ClinicalTrials.gov ID
- NCT03394716
- Acronym / sponsor ID
- N17MRB
- Conditions
- Brain Tumor
- Keywords
- MRI, Radiotherapy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low inclusion rate; Change of position of principal investigator.
- Enrolment
- 45 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 9 Jan 2018 (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 study aims to evaluate anatomical and functional changes during RT for patients receiving fractionated RT for brain tumors. Anatomical changes during RT will be registered and analyzed and if needed the radiotherapy plan will be modified for the individual patient. This means that the "to be irradiated volume" will be modified according to the shape changes of the tumor. The functional MRI sequences will be used to evaluate what parameters, and at which time point, are important for radiotherapy outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient brain tumor treated with fractionated radiotherapy | – | Radiation: Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastasis in the brain from extracranial solid tumors or patients with primary brain tumors who will be treated with fractionated radiotherapy.
Key inclusion criteria (3 listed)
- Primary brain tumor (WHO IV, GBM); treated with fractionated radiotherapy with or without preceding surgery. Systemic treatment is allowed before and during radiotherapy.
- Brain metastasis (from a solid extracranial tumor) eligible for treatment with fractionated radiotherapy with or without preceding surgery. Systemic treatment is allowed before and during radiotherapy.
- Also, postoperative patients with a macroscopic residual tumor lesion can be included (the diagnosis of residual diseases is defined by the treating neurosurgeon or on the MRI executed within 24 hours after the surgery, the diagnosis of residual macroscopic disease should always be confirmed during the neuro-oncology multidisciplinary meeting).
Key exclusion criteria (4 listed)
- Patients receiving Whole Brain RT (WBRT)
- Patient with a poor kidney function (GFR < 30 mL/min; CKD 4 and 5; patients on dialysis and patients with acute kidney insufficiency)
- None, doubtful or very small (<5 mm in its largest dimension) contrast enhancing lesion
- Patients with a contraindication for MRI
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 |
|---|---|---|
| Radiotherapystandard radiotherapy treatment with 1-3 extra MRIs | Radiation | Patient brain tumor treated with fractionated radiotherapy |
Primary outcome
MRI parameters in the target volume
Time frame: through study completion, an average of 3 years
functional MRI parameters (permeability, perfusion and diffusion) in the target volume before and during fractional radiotherapy treatment
anatomical variations in position, shape and size in the target volume
Time frame: through study completion, an average of 3 years
The difference is position shape and size in the target volume before and during fractional radiotherapy treatment. In case there is no macroscopic extension beyond the clinical target volume the new target volumes (gross target volume (GTV) and clinical target volume (CTV).) will also (but later) be delineated for analysis of volume changes, center of mass changes and distance measurements between the delineation on planning MRI versus repeated MRI.
2 secondary outcomes
the correlation between MRI parameters to the treatment outcome
Time frame: through study completion, an average of 3 years
the correlation between anatomical variations and the treatment outcome
Time frame: through study completion, an average of 3 years
Results and safety
The study was stopped early (reason given: Low inclusion rate; Change of position of principal investigator.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Brain Tumor, run by The Netherlands Cancer Institute at 1 site in Netherlands.
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 19 Apr 2021. 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 Netherlands. 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 was stopped early (reason given: Low inclusion rate; Change of position of principal investigator.). Results are not available in the source record.
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?
MRI parameters in the target volume (time frame: through study completion, an average of 3 years). The study lists 2 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 19 Apr 2021.