Brain NeoplasmsTCSEQNCT02791360
Evaluation of Anatomy, Clinical and Neuropsychological Long-term Sequelae of Patients Treated With Radiation Therapy for Brain Tumor
A study testing Brain MRI in people with Brain Neoplasms, run by Centre Francois Baclesse at 1 site in France.
Trial summary
Through this study, the investigators believe to describe more accurately the damage caused by brain radiation therapy in the long term. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Neoplasms
- What is being tested?
- Brain MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In the case group:
- A history of solid brain tumor or haematological histologically proven.
- Patients previously treated with radiotherapy in this brain tumor (greater than or equal to 36 Gy dose).
- Radiotherapy treatment on a tumor in place or operated.
- Decline at least 10 years from the end of radiotherapy.
- Treatment with isocentric conformal radiotherapy.
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- No other radiation therapy for locally recurrent brain metastases or new brain tumor.
- Lack of known brain metastases or meningeal carcinomatosis.
- For the control group:
- Patients previously treated for cancer and disease relapse free for 10 years.
- No brain radiotherapy treatment.
- Lack of treatment with anti-cancer chemotherapy.
- Women of childbearing potential must be under effective contraception.
- Pairing according to age, sex, arms director and socio-cultural level.
- For two groups:
- Man or woman aged (e) of minimum 18 years.
- Topic fluent French and comprising well.
- Free and Informed Consent signed.
- The subject should be affiliated to an appropriate social security system
- No cons-indication to MRI.
- The subject must have at least one primary school level
Who cannot join
- In the case group:
- Brain radiotherapy carried out by intensity modulation technique.
- Radiation dose less than 36 Gy on the brain.
- Subject with against-indication to MRI.
- For the control group:
- Previous history of brain radiotherapy.
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- Previous history of brain surgery.
- Central neurological disorders, such as seizures, uncontrolled.
- For two groups:
- Current Topics in oral chemotherapy or intravenous.
- Subject pregnant.
- Subject is not fluent in French or including bad.
- Any geographical conditions, social or associated psychopathology that could compromise the patient's ability to participate in the study.
- Participation in a therapeutic trial for less than 30 days.
- A person not affiliated with a social security scheme.
Trial locations and contacts
1 site in 1 country.
About this study
Through this study, the investigators believe to describe more accurately the damage caused by brain radiation therapy in the long term.
- Conditions
- Brain Neoplasms
- Being tested
- Brain MRI
- Keywords
- Brain, Radiotherapy, MRI, Sequelae
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRIOther
| Study group | Role | What they receive |
|---|---|---|
| MRI evaluation | Other | Patient pretreated for brain tumor and witness Receives: Other: Brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patient with MRI abnormality
To evaluate the proportion of patients with at least one abnormality on an imaging test
Measured: up to 4 weeks
Secondary outcomes (3)
MRI diffusion abnormality
Measured: up to 4 weeks
MRI perfusion abnormality
Measured: up to 4 weeks
MRI vascular morphologic abnormalities
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791360
- Sponsor's protocol ID
- TCSEQ
- Acronym
- TCSEQ
- Status last verified
- Jan 2018
- First submitted
- 17 May 2016
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anatomy, Clinical and Neuropsychological Long-term Sequelae of Patients Treated With Radiation Therapy for Brain Tumor
- ClinicalTrials.gov ID
- NCT02791360
- Acronym / sponsor ID
- TCSEQ / TCSEQ
- Conditions
- Brain Neoplasms
- Keywords
- Brain, Radiotherapy, MRI, Sequelae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 6 Jun 2016 (estimated)
- 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.
Through this study, the investigators believe to describe more accurately the damage caused by brain radiation therapy in the long term.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI evaluation | Other | Other: Brain MRIPatient pretreated for brain tumor and witness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- A history of solid brain tumor or haematological histologically proven.
- Patients previously treated with radiotherapy in this brain tumor (greater than or equal to 36 Gy dose).
- Radiotherapy treatment on a tumor in place or operated.
- Decline at least 10 years from the end of radiotherapy.
- Treatment with isocentric conformal radiotherapy.
Key exclusion criteria (15 listed)
- Brain radiotherapy carried out by intensity modulation technique.
- Radiation dose less than 36 Gy on the brain.
- Subject with against-indication to MRI.
- Previous history of brain radiotherapy.
- Previous history of brain surgery.
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 |
|---|---|---|
| Brain MRI | Other | MRI evaluation |
Primary outcome
Proportion of patient with MRI abnormality
Time frame: up to 4 weeks
To evaluate the proportion of patients with at least one abnormality on an imaging test
3 secondary outcomes
MRI diffusion abnormality
Time frame: up to 4 weeks
MRI perfusion abnormality
Time frame: up to 4 weeks
MRI vascular morphologic abnormalities
Time frame: up to 4 weeks
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 26 Jan 2018.
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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?
A study testing Brain MRI in people with Brain Neoplasms, run by Centre Francois Baclesse at 1 site in France.
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 21 inclusion and 15 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 26 Jan 2018. 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 France. 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?
Proportion of patient with MRI abnormality (time frame: up to 4 weeks). 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 26 Jan 2018.