RecruitingNCT07927595ClinicalTrials.gov record

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

Glioma · Glioma (Any Grade) in the Brain · Glioblastom WHO Grade 4 · Glioblastoma · Glioblastoma (GBM) · Grade III Astrocytoma · Grade II Glioma · Grade IV Astrocytoma · Grade IV Glioma · Grade III Glioma

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Observational
Phase: Not applicable / not listed
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 125 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full description

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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 population

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

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not reported
Masking: Not reported

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.

Other: Connectome MRI · Other: Neuropsychological testing

Connectome MRI OTHER

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 OTHER

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

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