Observational Connectomics in Adults Undergoing Resection of WHO II-IV Glioma
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Tamika Wong, MPH
- Telefonnummer: 212-434-4836
- E-post: twong4@northwell.edu
Studer Kontakt Backup
- Navn: Randy D'Amico, MD
- Telefonnummer: 212-434-3900
- E-post: rdamico8@northwell.edu
Studiesteder
-
-
New York
-
New York, New York, Forente stater, 10075
- Rekruttering
- Lenox Hill Brain Tumor Center
-
Underetterforsker:
- David Langer, MD
-
Underetterforsker:
- Tamika Wong, MPH
-
Hovedetterforsker:
- Randy D'Amico, MD
-
Underetterforsker:
- John Boockvar, MD
-
Underetterforsker:
- Olivia Albers, NP
-
Ta kontakt med:
- Randy D'Amico, MD
- Telefonnummer: 212-434-3900
- E-post: rdamico8@northwell.edu
-
Ta kontakt med:
- Tamik Wong, MPH
- Telefonnummer: 212-434-4836
- E-post: twong4@northwell.edu
-
Underetterforsker:
- Netanel Ben-Shalom, MD, FNPS
-
Underetterforsker:
- Taylor Winby, NP
-
Underetterforsker:
- Elizabeth Lepski, NP
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Newly diagnosed and recurrent glioma (WHO grade II, III, IV) undergoing surgery
Beskrivelse
Inclusion Criteria:
- Age > 18 years.
- 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.
- Diffuse astrocytomas, multifocal gliomas, oligodendrogliomas, midline and brainstem gliomas are included.
- Previously treated (progressive, recurrent) gliomas are included. Thus, prior surgery, radiation therapy, anti-angiogenic therapy, electrical field therapy are not exclusions.
- 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.
- Must be able to undergo sequential MRI in a facility that can perform 30-directional MRI for connectomic analyses.
Exclusion Criteria:
- Juvenile pilocytic glioma (WHO I)
- 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,
- Inability to give informed consent.
- Tissue samples obtained at surgery are insufficient/ or non-diagnostic for glioma
- Expected survival < 90 days due to primary disease or medical co-morbidities. (e.g. sepsis, pneumonia, organ failure)
- Inability to have a MRI due to cardiac pacemaker, implants, claustrophobia, allergy to gadolinium,
- 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.
- Vulnerable population
- Medications. There are no restrictions on medications. Patients will receive best standard of care.
- 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.
- KPS < 40.
- Age < 17.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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. |
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.
Andre navn:
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:
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Connectomic Metrics
Tidsramme: From enrollment up to 5 years.
|
FWHM (Full width-Half maximum) |
From enrollment up to 5 years.
|
|
Connectomic Metrics
Tidsramme: From enrollment up to 5 years.
|
Network index |
From enrollment up to 5 years.
|
|
Connectomic Metrics
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
KPS
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Randy D'Amico, MD, Northwell Health
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 24-0143
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Clinical Data from the other study centers part of the Glioma Connectome Project (GCP) will be transferred pseudonymously.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .