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

3. November 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

125

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Vereinigte Staaten
    • New York
      • New York, New York, Vereinigte Staaten, 10075
        • Rekrutierung
        • Lenox Hill Brain Tumor Center
        • Unterermittler:
          • David Langer, MD
        • Unterermittler:
          • Tamika Wong, MPH
        • Hauptermittler:
          • Randy D'Amico, MD
        • Unterermittler:
          • John Boockvar, MD
        • Unterermittler:
          • Olivia Albers, NP
        • Kontakt:
        • Kontakt:
        • Unterermittler:
          • Netanel Ben-Shalom, MD, FNPS
        • Unterermittler:
          • Taylor Winby, NP
        • Unterermittler:
          • Elizabeth Lepski, NP

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: COHORT
  • Zeitperspektiven: PROSPECTIVE

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Sonstiges: 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:
  • MRT
Sonstiges: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Connectomic Metrics
Zeitfenster: From enrollment up to 5 years.

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

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
KPS
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Northwell Health

Mitarbeiter

StacheStrong

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Februar 2026

Primärer Abschluss (Geschätzt)

1. Februar 2028

Studienabschluss (Geschätzt)

1. Februar 2033

Studienanmeldedaten

Zuerst eingereicht

25. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. November 2026

Zuerst gepostet (Tatsächlich)

10. November 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. November 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 24-0143

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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