Recruiting

Observational Study

Sponsor:

Northwell Health

Code:

NCT07927595

Conditions

Glioma

Glioma (Any Grade) in the Brain

Glioblastom WHO Grade 4

Glioblastoma

Glioblastoma (GBM)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Connectome MRI

Neuropsychological testing

Study Details

Brief summary:

This observational study will create a large scale database (registry) of glioma patients' data across multiple participating institutions (hospitals) to study a range of clinical research questions.

Conditions

Glioma

Glioma (Any Grade) in the Brain

Glioblastom WHO Grade 4

Glioblastoma

Glioblastoma (GBM)

Study ID

NCT07927595

Start date

Feb 1, 2026

Status verified date

Aug, 2026

Completion date

Feb, 2033

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

125 participants

Anticipated

Interventions and Outcome Measures

Arms

Newly diagnosed or recurrent glioma (WH) II, III, or IV)

Newly diagnosed patients (by MRI) suspected of having a glioma (WHO II,III, or IV) who will undergo surgery with histological confirmation or patients undergoing surgery for recurrent glioma (WHO grades II, III, IV) whose histology confirms glioma and/or treatment effect.

Interventions

Connectome MRI

Advanced MRI imaging done preoperatively, immediately following surgery, one month after surgery, and 3 months after surgery, then every 2 to 3 months for the duration of the study. These images are being done as standard of care and include functional MRI resting state (rs-fMRI) and the anatomic MRI using diffusion-weighted MRI to develop a comprehensive map of the brain.

Neuropsychological testing

Neuropsychological test that will be administered on an iPad, and should take no more than one hour to complete. Subjects will first complete a mini mental state exam to assess their mental status. This will only take 5-10 minutes to complete. Based on the results they may undergo all or some of the following neuropsychological tests which will be completed on an iPad:

  • Reaction Time
  • Rapid Visual Information Processing
  • Paired Associates Learning Delayed Matching to Sample
  • Verbal Recognition Memory
  • Multitasking Test
  • Spatial Working Memory
  • Emotion Recognition Task

Primary outcome measure

  • Connectomic Metrics [ Time Frame: From enrollment up to 5 years. ]
  • Connectomic Metrics [ Time Frame: From enrollment up to 5 years. ]
  • Connectomic Metrics [ Time Frame: From enrollment up to 5 years. ]

Central Contacts and Locations

Central contacts

Randy D'Amico, MD

212-434-3900rdamico8@northwell.edu

Tamika Wong, MPH

212-434-4836twong4@northwell.edu

Locations

Lenox Hill Brain Tumor Center

Recruiting

New York, New York, United States, 10075

Contacts

Randy D'Amico, MD

212-434-3900rdamico8@northwell.edu

Tamik Wong, MPH

212-434-4836twong4@northwell.edu

Principal Investigator:

Randy D'Amico, MD

More Information

Sponsor

Northwell Health

Last update posted

Nov 10, 2026

Last verified

Aug, 2026

Keywords

  • Connectome
  • Observational

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-11. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.