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Observational Connectomics in Adults Undergoing Resection of WHO II-IV Glioma

3 november 2026 bijgewerkt door: Northwell Health

A Prospective, Longitudinal, Multi-Institutional, Observational Study to Correlate Quantitative Changes of the Human Structural and Functional Connectome in Adults Undergoing Neurosurgical Resection of WHO II-IV Glioma

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The Glioma Connectome Project (GCP) is a study that seeks to use safe, powerful, non-invasive computing tools of machine learning and artificial intelligence, to take information from the functional MRI resting state (rs-fMRI) and the anatomic MRI using diffusion-weighted MRI to develop a comprehensive map of the brain. This "Virtual Brain" in the future may assist neurosurgeons in planning glioma surgery, understanding the cause of neurological deficits caused by the tumor, and a road map to help avert postoperative deficits, while also monitoring recovery of neurological function, as the brain "heals" or reorganizes itself through neuroplasticity.

The information from your MRI will be analyzed using algorithms to produce a map of the key tracts, functional hubs, and connections in the brain in terms of seven major networks: sensorimotor, visual, central executive (CEN), default mode (DMN), salience, dorsal attention (DAN) and limbic system. The completion of the project will advance diagnostics, brain imaging, brain tumor surgery, and provide the basis for new tools and drugs to treat brain injury and accelerate recovery of neurological function lost to the tumor, and treatments for the tumor, including surgery, radiation, chemotherapy.

The registry is being created to evaluate new computer-based technology that builds on ourknowledge of the human brain through the Glioma Connectome Project, which discovered that the brain could be divided into 180 areas per hemisphere or "parcellations", each with a function that is achieved by signaling other areas, forming broad networks, which influence brain function and brain health. Seven major networks are of great interest as they influence human neurological performance. These networks will be identified in the current study, throughout the course of the treatment for your glioma, by using the advanced neuroimaging which is standard of care at Lenox Hill Hospital.

Studietype

Observationeel

Inschrijving (Geschat)

125

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • New York
      • New York, New York, Verenigde Staten, 10075
        • Werving
        • Lenox Hill Brain Tumor Center
        • Onderonderzoeker:
          • David Langer, MD
        • Onderonderzoeker:
          • Tamika Wong, MPH
        • Hoofdonderzoeker:
          • Randy D'Amico, MD
        • Onderonderzoeker:
          • John Boockvar, MD
        • Onderonderzoeker:
          • Olivia Albers, NP
        • Contact:
        • Contact:
        • Onderonderzoeker:
          • Netanel Ben-Shalom, MD, FNPS
        • Onderonderzoeker:
          • Taylor Winby, NP
        • Onderonderzoeker:
          • Elizabeth Lepski, NP

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Newly diagnosed and recurrent glioma (WHO grade II, III, IV) undergoing surgery

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Ander: 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.

Andere namen:
  • MRI
Ander: 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
Andere namen:
  • Cambridge Cognition
  • Mini Mental State Exam

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Connectomic Metrics
Tijdsspanne: From enrollment up to 5 years.

FWHM (Full width-Half maximum)
From enrollment up to 5 years.
Connectomic Metrics
Tijdsspanne: From enrollment up to 5 years.

Network index
From enrollment up to 5 years.
Connectomic Metrics
Tijdsspanne: From enrollment up to 5 years.

Betweenness centrality (the value of each node to the whole network, defined by the fraction of the shortest paths passing through this node to all shortest paths that do not pass through it)
From enrollment up to 5 years.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
KPS
Tijdsspanne: From enrollment up to 5 years.

The KPS describes a patient's functional status as a comprehensive 11-point scale correlating to percentage values ranging from 100% (no evidence of disease, no symptoms) to 0% (death). Each percentage reflects the patient's ability to perform daily activities and their level of independence or care needs. For instance, 100% indicates full independence, while 10% describes a moribund state with rapid disease progression.
From enrollment up to 5 years.
Progression-free survival
Tijdsspanne: From enrollment up to 5 years.

Progression-free survival (PFS) is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease without it getting worse, growing, or spreading
From enrollment up to 5 years.
Overall survival (OS)
Tijdsspanne: From enrollment up to 5 years.

Overall survival (OS) is the length of time from either the date of diagnosis or the start of a treatment until death from any cause.
From enrollment up to 5 years.
Molecular markers and drivers of glioma growth
Tijdsspanne: From enrollment up to 5 years.

IDH mutational status, MGMT, ki-67, EGFR, p53, ATRX, TERT promoter, 1p19q chromosomal deletions, extent of resection, length of hospital stay
From enrollment up to 5 years.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Northwell Health

Medewerkers

StacheStrong

Onderzoekers

  • Hoofdonderzoeker: Randy D'Amico, MD, Northwell Health

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 februari 2026

Primaire voltooiing (Geschat)

1 februari 2028

Studie voltooiing (Geschat)

1 februari 2033

Studieregistratiedata

Eerst ingediend

25 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 november 2026

Eerst geplaatst (Werkelijk)

10 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 november 2026

Laatste update ingediend die voldeed aan QC-criteria

3 november 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 24-0143

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Clinical Data from the other study centers part of the Glioma Connectome Project (GCP) will be transferred pseudonymously.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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