Malignant Brain TumorNODDI-TRACTNCT05669326
Evaluation of the Contribution of NODDI Protocol Tractography in Brain Tumor Surgery
A study testing NODDI TRACT in people with Malignant Brain Tumor, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The objective of this study is to evaluate to what extent the capacity of the NODDI model can allow, in case of Malignant brain tumor patients with vasogenic edema, the elaboration of a reliable cerebral functional mapping in accordance with the data of direct electrical stimulation (DES) which is today the reference… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Brain Tumor
- What is being tested?
- NODDI TRACT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2024to 1 Sep 2025
- 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
- Patient 18 years of age or older,
- Patient who has read and signed the consent form for participation in the study
- Patient requiring surgery for a malignant brain tumor with vasogenic edema
- Patient with an estimated life expectancy of more than 3 months.
Who cannot join
- Patient under legal protection, guardianship or trusteeship
- Patient not affiliated to the French social security system
- Contraindication to MRI (patient with a pacemaker or cardiac defibrillator, implanted equipment activated by an electrical, magnetic or mechanical system, patient with hemostatic clips on intracerebral aneurysms or with orthopedic implants, claustrophobic patient)
- Psychiatric history
- Refusal to be informed of an abnormality detected during the MRI
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to evaluate to what extent the capacity of the NODDI model can allow, in case of Malignant brain tumor patients with vasogenic edema, the elaboration of a reliable cerebral functional mapping in accordance with the data of direct electrical stimulation (DES) which is today the reference tool.
the patient's participation in this study implies an additional visit during which an MRI examination without injection of contrast medium will be performed, lasting approximately 40 minutes (including installation and de-installation).
Read the detailed description
This is a single-center, prospective, open-label study of neurosurgical patients.
Compared to their usual management, the participation of the patient in this study implies an additional visit during which an MRI examination without injection of contrast product will be performed, lasting approximately 40 minutes (including installation and de-installation).
The operative time, surgical procedures and postoperative follow-up are not modified in this study
- Conditions
- Malignant Brain Tumor
- Being tested
- NODDI TRACT
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NODDI TRACTOther
Compared to their usual management, the participation of the patient in this study implies an additional visit during which an MRI examination without contrast injection will be performed, lasting approximately 40 minutes (including installation and deinstallation).
The operative time, surgical procedures and postoperative follow-up are not modified in this study.
| Study group | Role | What they receive |
|---|---|---|
| NODDI TRACT | Experimental | * Diffusion MRI (tractography) Tractography is performed on the basis of a diffusion MRI sequence which, after computer processing, will result in a map of the apparent diffusion coefficient and a diffusion tensor beam reconstruction (DTI tractography) performed with the Sisyphus software.
* Multi-shell diffusion MRI (NODDI-tract) Receives: Other: NODDI TRACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to electrical stimulation
Response to electrical stimulation, which determines the presence or absence of an essential bundle, is the primary end point.
The ability of the NODDI-tract method to reconstruct essential bundles in vasogenic edema will be assessed by estimating the correspondence between the response to intraoperative direct electrical stimulation (DES) and the presence of an MRI reconstructed bundle.
Based on the response to electrical stimulation, the NODDI-tract data will be classified into one of four groups:
- True positive = response to stimulation and presence of an MRI beam
- True negative = no response to stimulation and no beam on MRI
- False positive = no response to stimulation and presence of a beam on MRI
- False-negative = response to stimulation and absence of beam in MRI. The distance between the reconstructed beam and the stimulation point (whether or not the stimulation was effective) will also be measured.
Measured: Hour 24
Secondary outcomes (2)
Number of reconstructed fibers
Reconstructions obtained using the NODDI protocol or tractography will be compared on the total number of fibers reconstructed by both methods.
The comparison will be made on the total number of reconstructed fibers and on the number of reconstructed fibers crossing the edema.
Measured: Hour 24
Average distance to a reference atlas
The comparison is based on the evaluation of the average distance between the skeleton of the NODDI-tract reconstructed beams and that of the JHU tractography atlas [20]. The distance will be calculated by projecting the reconstructed skeleton onto the atlas skeleton, and as a function of the length traveled on the parameterized curve representing the skeleton. This function will be averaged over the entire length of the skeleton. An average distance of less than 1cm will be considered as a match criterion.
Measured: Hour 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start1 Sep 2024
- Primary completion1 Sep 2025
- Study completion1 Sep 2025 (estimated)
Why it stopped: No recrutment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Brain TumorStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669326
- Sponsor's protocol ID
- 2021-A02074-37
- Acronym
- NODDI-TRACT
- Status last verified
- Nov 2025
- First submitted
- 20 Dec 2022
- Last updated
- 3 Dec 2025
- 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 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Contribution of NODDI Protocol Tractography in Brain Tumor Surgery
- ClinicalTrials.gov ID
- NCT05669326
- Acronym / sponsor ID
- NODDI-TRACT / 2021-A02074-37
- Conditions
- Malignant Brain Tumor
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No recrutment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 30 Dec 2022 (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.
The objective of this study is to evaluate to what extent the capacity of the NODDI model can allow, in case of Malignant brain tumor patients with vasogenic edema, the elaboration of a reliable cerebral functional mapping in accordance with the data of direct electrical stimulation (DES) which is today the reference tool.
the patient's participation in this study implies an additional visit during which an MRI examination without injection of contrast medium will be performed, lasting approximately 40 minutes (including installation and de-installation).
Detailed description
This is a single-center, prospective, open-label study of neurosurgical patients.
Compared to their usual management, the participation of the patient in this study implies an additional visit during which an MRI examination without injection of contrast product will be performed, lasting approximately 40 minutes (including installation and de-installation).
The operative time, surgical procedures and postoperative follow-up are not modified in this study
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NODDI TRACT | Experimental | Other: NODDI TRACT* Diffusion MRI (tractography) Tractography is performed on the basis of a diffusion MRI sequence which, after computer processing, will result in a map of the apparent diffusion coefficient and a diffusion tensor beam reconstruction (DTI tractography) performed with the Sisyphus software. * Multi-shell diffusion MRI (NODDI-tract) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient 18 years of age or older,
- Patient who has read and signed the consent form for participation in the study
- Patient requiring surgery for a malignant brain tumor with vasogenic edema
- Patient with an estimated life expectancy of more than 3 months.
Key exclusion criteria (6 listed)
- Patient under legal protection, guardianship or trusteeship
- Patient not affiliated to the French social security system
- Contraindication to MRI (patient with a pacemaker or cardiac defibrillator, implanted equipment activated by an electrical, magnetic or mechanical system, patient with hemostatic clips on intracerebral aneurysms or with orthopedic implants, claustrophobic patient)
- Psychiatric history
- Refusal to be informed of an abnormality detected during the 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 |
|---|---|---|
| NODDI TRACTCompared to their usual management, the participation of the patient in this study implies an additional visit during which an MRI examination without contrast injection will be performed, lasting approximately 40 minutes (including installation and deinstallation). The operative time, surgical procedures and postoperative follow-up are not modified in this study. | Other | NODDI TRACT |
Primary outcome
Response to electrical stimulation
Time frame: Hour 24
Response to electrical stimulation, which determines the presence or absence of an essential bundle, is the primary end point. The ability of the NODDI-tract method to reconstruct essential bundles in vasogenic edema will be assessed by estimating the correspondence between the response to intraoperative direct electrical stimulation (DES) and the presence of an MRI reconstructed bundle. Based on the response to electrical stimulation, the NODDI-tract data will be classified into one of four groups: * True positive = response to stimulation and presence of an MRI beam * True negative = no response to stimulation and no beam on MRI * False positive = no response to stimulation and presence of a beam on MRI * False-negative = response to stimulation and absence of beam in MRI. The distance between the reconstructed beam and the stimulation point (whether or not the stimulation was effective) will also be measured.
2 secondary outcomes
Number of reconstructed fibers
Time frame: Hour 24
Average distance to a reference atlas
Time frame: Hour 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- 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?
A study testing NODDI TRACT in people with Malignant Brain Tumor, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 3 Dec 2025. 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 was withdrawn before enrolling participants, so there are no results.
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?
Response to electrical stimulation (time frame: Hour 24). 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 3 Dec 2025.