Brain NeoplasmsCONNECT TrailNCT07657403
CONNEctome-guided Navigation for Eloquent-area Tumor Surgery Trial
A study testing Connectome-Guided Navigation-Assisted Microsurgical Resection and Conventional DTI Tractography-Guided Tumor Resection in people with Brain Neoplasms and Eloquent Area Brain Tumors, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study is designed for patients with brain tumors located in eloquent brain areas involved in language, motor, or major functional brain networks. The purpose of the study is to determine whether connectome-guided navigation-assisted microsurgical resection can better preserve neurological function after surgery… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Neoplasms, Eloquent Area Brain Tumors
- What is being tested?
- Connectome-Guided Navigation-Assisted Microsurgical Resection and Conventional DTI Tractography-Guided Tumor Resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients clinically diagnosed with brain tumors involving language areas, motor areas, or major functional brain networks, including the default mode network, central executive network, dorsal attention network, or ventral attention network.
- Karnofsky Performance Status (KPS) score of 70 or higher.
- Preoperative MRI demonstrating a spatial relationship between the tumor and major white matter tracts, such as the corticospinal tract or arcuate fasciculus.
- No other neurological disease or underlying condition that may cause neurological dysfunction.
- No prior treatment for a brain tumor in the same region, such as radiotherapy.
- Tumor not extensively adherent to multiple critical network nodes.
- Planned craniotomy for tumor resection and provision of written informed consent by the patient or legally authorized representative.
Who cannot join
- Pathologically or clinically suspected non-neoplastic brain lesion.
- Multifocal tumors.
- Incomplete evaluation data.
- Withdrawal from the study by the patient or legally authorized representative for any reason.
- Pregnancy, lactation, possibility of pregnancy, or planned pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, 100021
Ming Yang, M.D., +8613810655237, yangming@cicams.ac.cn
About this study
Official title: A Prospective, Randomized, Controlled Superiority Trial of Connectome-Guided Navigation-Assisted Microsurgical Resection for Functional Preservation in Eloquent-Area Brain Tumors
This study is designed for patients with brain tumors located in eloquent brain areas involved in language, motor, or major functional brain networks. The purpose of the study is to determine whether connectome-guided navigation-assisted microsurgical resection can better preserve neurological function after surgery than conventional tractography-guided surgery.
Participants who meet the study criteria will be assigned to one of two surgical planning strategies. In the experimental group, patients will undergo preoperative diffusion tensor imaging and resting-state functional MRI for individualized brain network reconstruction, and these data will be integrated with intraoperative navigation and neurophysiological monitoring to guide the resection boundary. In the control group, surgery will be guided by conventional DTI tractography-assisted navigation.
The main outcome is the rate of postoperative functional preservation. Other outcomes include extent of tumor resection, postoperative complications, time to neurological recovery, overall survival, and quality of life. Patients will be evaluated before surgery and followed after surgery with clinical examinations, neurological assessments, and MRI at prespecified time points.
Read the detailed description
This is a prospective, randomized, controlled superiority trial designed to evaluate whether connectome-guided navigation-assisted microsurgical resection improves postoperative functional preservation in patients with tumors located in eloquent brain regions when compared with conventional tractography-guided surgery.
Brain tumors involving language areas, motor areas, or key large-scale functional networks present a major surgical challenge because maximal resection must be balanced against preservation of neurological function. Conventional neuronavigation based mainly on structural landmarks or tractography may be insufficient to fully characterize the topological relationship between the tumor and critical functional networks. This study therefore applies a connectome-informed surgical strategy that integrates preoperative structural and functional imaging with intraoperative guidance to support individualized surgical planning and functional protection.
Eligible patients are those with brain tumors involving language, motor, or major functional network regions, including the default mode network, central executive network, dorsal attention network, and ventral attention network, with Karnofsky Performance Status of at least 70 and preoperative MRI evidence of a spatial relationship between the tumor and major white matter tracts. Patients with non-neoplastic lesions, multifocal tumors, incomplete evaluation data, pregnancy-related conditions, or extensive adhesion to multiple key network nodes are excluded.
Participants are randomized in a 1:1 ratio to the experimental group or the control group. The experimental intervention includes preoperative DTI and resting-state functional MRI-based brain network reconstruction, intraoperative real-time navigation, electrophysiological monitoring, and resection planning based on network-informed boundaries. The control intervention consists of conventional DTI tractography-guided tumor resection.
The primary endpoint is postoperative functional preservation. Secondary endpoints include extent of resection, postoperative complication rate, time to neurological recovery, overall survival, progression-related outcomes, and quality of life. Exploratory analyses will assess postoperative dynamic changes in brain networks and functional compensation mechanisms using multimodal MRI data, including resting-state functional MRI and diffusion imaging.
Study assessments are performed at baseline, within 24 to 72 hours after surgery, and during postoperative follow-up at 1 month, 3 months, 6 months, and 1 year. MRI is used to evaluate extent of resection, while neurological examinations, performance scales, and clinical rating instruments are used to assess functional outcomes over time. Quality of life is assessed using validated cancer-related instruments during follow-up.
The planned total sample size is 200 participants, with 100 patients in each group, based on a superiority design using postoperative functional preservation as the primary endpoint. Data will be analyzed using predefined statistical methods, including descriptive statistics, between-group comparisons, survival analysis, and modeling of factors associated with postoperative neurological impairment.
- Conditions
- Brain Neoplasms, Eloquent Area Brain Tumors
- Being tested
- Connectome-Guided Navigation-Assisted Microsurgical Resection, Conventional DTI Tractography-Guided Tumor Resection
- Keywords
- Connectome-guided surgery, Eloquent area brain tumor, Brain network navigation, Diffusion tensor imaging, DTI tractography, Resting-state fMRI, Functional preservation, Microsurgical resection, Intraoperative neurophysiological monitoring
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connectome-Guided Navigation-Assisted Microsurgical ResectionProcedure or surgery
Also called Brain network-guided surgery, Connectome-guided surgery, DTI and rs-fMRI-guided tumor resection
Microsurgical resection of eloquent-area brain tumors guided by preoperative diffusion tensor imaging and resting-state functional MRI-based brain network reconstruction. The intervention integrates connectome-informed surgical planning, intraoperative neuronavigation, and neurophysiological monitoring to define individualized resection boundaries with the goal of maximizing tumor removal while preserving neurological function.
Conventional DTI Tractography-Guided Tumor ResectionProcedure or surgery
Also called Conventional tractography-guided surgery, DTI-guided microsurgical resection, Standard tractography-assisted tumor resection
Microsurgical resection of eloquent-area brain tumors guided by conventional diffusion tensor imaging tractography-assisted navigation according to standard surgical planning procedures. This intervention serves as the comparator for evaluation of postoperative functional preservation, extent of resection, and other clinical outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Connectome-Guided Surgery Group | Experimental | Participants in this arm will undergo connectome-guided navigation-assisted microsurgical resection. The surgical strategy includes preoperative diffusion tensor imaging and resting-state functional MRI-based brain network reconstruction, integrated with intraoperative neuronavigation and neurophysiological monitoring to guide resection boundaries and optimize postoperative functional preservation. Receives: Procedure: Connectome-Guided Navigation-Assisted Microsurgical Resection |
| Conventional Tractography-Guided Surgery Group | Active comparator | Participants in this arm will undergo conventional DTI tractography-guided microsurgical resection using standard surgical planning and navigation procedures. This group serves as the comparator for evaluating postoperative functional preservation and extent of resection. Receives: Procedure: Conventional DTI Tractography-Guided Tumor Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Functional Preservation Rate
The proportion of participants with preservation of neurological function at 6 months after surgery compared with baseline, based on neurological examination and protocol-specified functional assessments.
Measured: 6 months after surgery
Secondary outcomes (2)
Extent of Resection
Extent of tumor resection assessed on postoperative contrast-enhanced brain MRI performed within 24 to 72 hours after surgery.
Measured: Within 24 to 72 hours after surgery
Incidence of Postoperative Complications
The incidence of surgery-related postoperative complications, including new or worsened neurological deficits, intracranial hemorrhage, brain edema, seizures, intracranial infection, deep vein thrombosis, and other protocol-defined adverse events.
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Nov 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to one of two parallel groups. The experimental group will undergo connectome-guided navigation-assisted microsurgical resection based on preoperative DTI and resting-state fMRI brain network reconstruction combined with intraoperative navigation and neurophysiological monitoring. The control group will undergo conventional DTI tractography-guided tumor resection.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657403
- Sponsor's protocol ID
- NCC-020019
- Other IDs
- 2024-I2M-3-014
- Acronym
- CONNECT Trail
- Status last verified
- Nov 2025
- First submitted
- 14 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Superiority Trial of Connectome-Guided Navigation-Assisted Microsurgical Resection for Functional Preservation in Eloquent-Area Brain Tumors
- ClinicalTrials.gov ID
- NCT07657403
- Acronym / sponsor ID
- CONNECT Trail / NCC-020019
- Conditions
- Brain Neoplasms, Eloquent Area Brain Tumors
- Keywords
- Connectome-guided surgery, Eloquent area brain tumor, Brain network navigation, Diffusion tensor imaging, DTI tractography, Resting-state fMRI, Functional preservation, Microsurgical resection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Jun 2026 (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 is designed for patients with brain tumors located in eloquent brain areas involved in language, motor, or major functional brain networks. The purpose of the study is to determine whether connectome-guided navigation-assisted microsurgical resection can better preserve neurological function after surgery than conventional tractography-guided surgery.
Participants who meet the study criteria will be assigned to one of two surgical planning strategies. In the experimental group, patients will undergo preoperative diffusion tensor imaging and resting-state functional MRI for individualized brain network reconstruction, and these data will be integrated with intraoperative navigation and neurophysiological monitoring to guide the resection boundary. In the control group, surgery will be guided by conventional DTI tractography-assisted navigation.
The main outcome is the rate of postoperative functional preservation. Other outcomes include extent of tumor resection, postoperative complications, time to neurological recovery, overall survival, and quality of life. Patients will be evaluated before surgery and followed after surgery with clinical examinations, neurological assessments, and MRI at prespecified time points.
Detailed description
This is a prospective, randomized, controlled superiority trial designed to evaluate whether connectome-guided navigation-assisted microsurgical resection improves postoperative functional preservation in patients with tumors located in eloquent brain regions when compared with conventional tractography-guided surgery.
Brain tumors involving language areas, motor areas, or key large-scale functional networks present a major surgical challenge because maximal resection must be balanced against preservation of neurological function. Conventional neuronavigation based mainly on structural landmarks or tractography may be insufficient to fully characterize the topological relationship between the tumor and critical functional networks. This study therefore applies a connectome-informed surgical strategy that integrates preoperative structural and functional imaging with intraoperative guidance to support individualized surgical planning and functional protection.
Eligible patients are those with brain tumors involving language, motor, or major functional network regions, including the default mode network, central executive network, dorsal attention network, and ventral attention network, with Karnofsky Performance Status of at least 70 and preoperative MRI evidence of a spatial relationship between the tumor and major white matter tracts. Patients with non-neoplastic lesions, multifocal tumors, incomplete evaluation data, pregnancy-related conditions, or extensive adhesion to multiple key network nodes are excluded.
Participants are randomized in a 1:1 ratio to the experimental group or the control group. The experimental intervention includes preoperative DTI and resting-state functional MRI-based brain network reconstruction, intraoperative real-time navigation, electrophysiological monitoring, and resection planning based on network-informed boundaries. The control intervention consists of conventional DTI tractography-guided tumor resection.
The primary endpoint is postoperative functional preservation. Secondary endpoints include extent of resection, postoperative complication rate, time to neurological recovery, overall survival, progression-related outcomes, and quality of life. Exploratory analyses will assess postoperative dynamic changes in brain networks and functional compensation mechanisms using multimodal MRI data, including resting-state functional MRI and diffusion imaging.
Study assessments are performed at baseline, within 24 to 72 hours after surgery, and during postoperative follow-up at 1 month, 3 months, 6 months, and 1 year. MRI is used to evaluate extent of resection, while neurological examinations, performance scales, and clinical rating instruments are used to assess functional outcomes over time. Quality of life is assessed using validated cancer-related instruments during follow-up.
The planned total sample size is 200 participants, with 100 patients in each group, based on a superiority design using postoperative functional preservation as the primary endpoint. Data will be analyzed using predefined statistical methods, including descriptive statistics, between-group comparisons, survival analysis, and modeling of factors associated with postoperative neurological impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to one of two parallel groups. The experimental group will undergo connectome-guided navigation-assisted microsurgical resection based on preoperative DTI and resting-state fMRI brain network reconstruction combined with intraoperative navigation and neurophysiological monitoring. The control group will undergo conventional DTI tractography-guided tumor resection.
| Arm | Type | Receives |
|---|---|---|
| Connectome-Guided Surgery Group | Experimental | Procedure: Connectome-Guided Navigation-Assisted Microsurgical ResectionParticipants in this arm will undergo connectome-guided navigation-assisted microsurgical resection. The surgical strategy includes preoperative diffusion tensor imaging and resting-state functional MRI-based brain network reconstruction, integrated with intraoperative neuronavigation and neurophysiological monitoring to guide resection boundaries and optimize postoperative functional preservation. |
| Conventional Tractography-Guided Surgery Group | Active comparator | Procedure: Conventional DTI Tractography-Guided Tumor ResectionParticipants in this arm will undergo conventional DTI tractography-guided microsurgical resection using standard surgical planning and navigation procedures. This group serves as the comparator for evaluating postoperative functional preservation and extent of resection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients clinically diagnosed with brain tumors involving language areas, motor areas, or major functional brain networks, including the default mode network, central executive network, dorsal attention network, or ventral attention network.
- Karnofsky Performance Status (KPS) score of 70 or higher.
- Preoperative MRI demonstrating a spatial relationship between the tumor and major white matter tracts, such as the corticospinal tract or arcuate fasciculus.
- No other neurological disease or underlying condition that may cause neurological dysfunction.
- No prior treatment for a brain tumor in the same region, such as radiotherapy.
Key exclusion criteria (5 listed)
- Pathologically or clinically suspected non-neoplastic brain lesion.
- Multifocal tumors.
- Incomplete evaluation data.
- Withdrawal from the study by the patient or legally authorized representative for any reason.
- Pregnancy, lactation, possibility of pregnancy, or planned pregnancy.
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 |
|---|---|---|
| Connectome-Guided Navigation-Assisted Microsurgical ResectionAlso: Brain network-guided surgery, Connectome-guided surgery, DTI and rs-fMRI-guided tumor resectionMicrosurgical resection of eloquent-area brain tumors guided by preoperative diffusion tensor imaging and resting-state functional MRI-based brain network reconstruction. The intervention integrates connectome-informed surgical planning, intraoperative neuronavigation, and neurophysiological monitoring to define individualized resection boundaries with the goal of maximizing tumor removal while preserving neurological function. | Procedure or surgery | Connectome-Guided Surgery Group |
| Conventional DTI Tractography-Guided Tumor ResectionAlso: Conventional tractography-guided surgery, DTI-guided microsurgical resection, Standard tractography-assisted tumor resectionMicrosurgical resection of eloquent-area brain tumors guided by conventional diffusion tensor imaging tractography-assisted navigation according to standard surgical planning procedures. This intervention serves as the comparator for evaluation of postoperative functional preservation, extent of resection, and other clinical outcomes. | Procedure or surgery | Conventional Tractography-Guided Surgery Group |
Primary outcome
Postoperative Functional Preservation Rate
Time frame: 6 months after surgery
The proportion of participants with preservation of neurological function at 6 months after surgery compared with baseline, based on neurological examination and protocol-specified functional assessments.
2 secondary outcomes
Extent of Resection
Time frame: Within 24 to 72 hours after surgery
Incidence of Postoperative Complications
Time frame: Within 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Brain Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
Not yet recruitingPhase 1/2
4SCAR-T Therapy Targeting GD2, PSMA and CD276 for Treating Neuroblastoma
Neuroblastoma
RecruitingEarly Phase 1
FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease
Cushing Disease, Pituitary Adenoma
RecruitingPhase 2
A Study of VRT106 in Combination With Radiotherapy in Adult Patients With Diffuse Midline Glioma / Diffuse Intrinsic Pontine Glioma
Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Intrinsic Pontine Glioma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connectome-Guided Navigation-Assisted Microsurgical Resection and Conventional DTI Tractography-Guided Tumor Resection in people with Brain Neoplasms and Eloquent Area Brain Tumors, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 18 Jun 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fengchun Mu (+8618888294650, alicemfc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Functional Preservation Rate (time frame: 6 months after surgery). 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 18 Jun 2026.