Brain connectome project in adults with brain glioma undergoing surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Glioma Connectome Project creates a large, multi-center registry of glioma patients to map brain connections using resting-state and diffusion MRI, combined with neuropsychology. Researchers use machine learning tools to build a virtual brain model detailing networks such as sensorimotor, visual, and default mode, aiming to aid surgical planning and understand postoperative deficits. The study does not assign treatments but analyzes data to improve diagnostics, imaging, and recovery strategies for brain tumors. Data will be collected from consenting adults who are undergoing surgery and may include previously treated gliomas. The project seeks to enable future tools and therapies geared toward preserving function and guiding treatment decisions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age \> 18 years.
2. Newly diagnosed patients (by MRI) suspected of having a brain tumor (WHO II,III, or IV) who will undergo surgery with histological confirmation or patients undergoing surgery for recurrent brain tumor (WHO grades II, III, IV) whose histology confirms glioma and/or treatment effect.
3. Diffuse astrocytomas, multifocal gliomas, oligodendrogliomas, midline and brainstem gliomas are included.
4. Previously treated (progressive, recurrent) gliomas are included. Thus, prior surgery, radiation therapy, anti-angiogenic therapy, electrical field therapy are not exclusions.
5. Patient must be able to give informed consent. S/he must be able to read and understand English or there must be a qualified interpreter.
6. Must be able to undergo sequential MRI in a facility that can perform 30-directional MRI for connectomic analyses.

Exclusion Criteria:

1. Juvenile pilocytic glioma (WHO I)
2. Histology that is non-glioma, e.g., brain metastases, craniopharyngioma, ependymoma, medulloblastoma, meningioma, lymphoma, tumefactive (demyelinative) plaque, abscess, germinoma, arachnoid cyst, epidermoid, PXA, DNET, ganglioglioma, central neurocytoma,
3. Inability to give informed consent.
4. Tissue samples obtained at surgery are insufficient/ or non-diagnostic for glioma
5. Expected survival \< 90 days due to primary disease or medical co-morbidities. (e.g. sepsis, pneumonia, organ failure)
6. Inability to have a MRI due to cardiac pacemaker, implants, claustrophobia, allergy to gadolinium,
7. Pregnancy. Because of potential risk of serial MRI to fetus, women of child-bearing age will need a pregnancy test and agree to contraceptive practices during the course of the study.
8. Vulnerable population
9. Medications. There are no restrictions on medications. Patients will receive best standard of care.
10. Clinical Trials. Patients may also be enrolled in a clinical trial as a clinical trial is always recommended for patients with a glioma per NCCN guidelines.
11. KPS \< 40.
12. Age \< 17.

Where it's running

• Lenox Hill Brain Tumor Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Randy D'Amico, MD — Northwell Health
• Study coordinator: Randy D'Amico, MD
• Email: rdamico8@northwell.edu
• Phone: 212-434-3900

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.