Neoplasms

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Central Nervous System Neoplasms

Nervous System Neoplasms

Spinal Cord Diseases

Central Nervous System Diseases

Neurofibromatosis

Patients undergo a preoperative routine MRI scan and MRE the day before their scheduled surgery. During surgery, the tumor stiffness and adhesion are assessed and recorded by the surgeon according to established evaluation criteria. It is important to note that the surgeon does not have prior knowledge of the tumor's specific stiffness and adhesion before the surgery. This information is typically obtained through intraoperative assessment and observation.

Magnetic Resonance Elastography

Undergo grading and recording of tumor stiffness and adhesion during surgery

Assessment and Recording

Yu Shi, MD

Wen Cheng, MD

Anhua Wu, MD

In spinal cord tumors requiring surgical intervention, the resection difficulty is determined by two significant factors: tumor stiffness and adhesion to surrounding tissue.

The stiffness of the tumor dictates the complexity of removal, while strong adhesion presents additional challenges during the surgical procedure.

This clinical trial aims to assess the clinical utility of magnetic resonance elastography (MRE), in evaluating the stiffness and adhesion of spinal cord tumors and guiding surgical planning to selecting the most appropriate surgical approach for patients with spinal cord tumors.

Spinal cord tumors are a common condition in neurosurgery, including neurofibroma, spinal meningioma, ependymoma, glioma, spinal lipoma, and so on.

Magnetic resonance imaging (MRI) plays a crucial role in the preoperative evaluation and planning of spinal cord tumor surgery. It provides detailed information about the tumor's location, size, and relationship to adjacent structures.

However, routine MRI may not always provide sufficient information about the tumor's stiffness or adhesion, which can impact surgical planning and postoperative outcomes. Magnetic resonance elastography and slip interface imaging can help measure the mechanical properties of tissues, including their stiffness or adhesion.

By combining the above methods, surgeons can identify areas of potential tumor adherence or invasion into surrounding structures, allowing for more precise surgical resection and minimizing the risk of damage to critical neural tissue.

MRE Evaluation for Spinal Cord Tumor Surgery: Stiffness and Adhesion Assessment

Preoperative Evaluation of Tumor Stiffness and Adhesion in Spinal Cord Tumor Using Magnetic Resonance Elastography

The surgeon will score the tumor stiffness in seven aspects, ranging from 1 to 5 points: Tumor size; Shape of tumor; Tumor texture; Stiffness of the tumor's capsule; Stiffness of the tumor's central region; Primary methods of tumor removal; Features of tumor's capsule.

The surgeon will score the tumor's adhesion based on seven aspects, ranging from 1 to 4 points: Stripping instruments; Frequency of use of sharp instruments; Adhesion range; Degree of tumor resection; Cranial nerve anatomy preservation; Brain tissue anatomy preservation; Neurological function (compared with preoperative).

Shengjing Hospital

Deputy director of department of radology

Carcinoma

Brain Neoplasms

Pinealoma

Brain Stem Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Brain Diseases

Pineocytoma

Choroid Plexus Carcinoma

Brain Tumor, Childhood

Pineoblastoma

Neuroepithelioma

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Pharmaceutical Solutions

Antineoplastic Agents

Other Dietary Supplements

Ethanol

Perillyl alcohol

Glycerol

Enzyme Inhibitors

Perillyl Alcohol

Patients will receive IN NEO100 that will follow a dose titration design, followed by a standard dose escalation design to establish safety. Brain tumor delivery of NEO100 will be confirmed in each disease sub-type by surgical resection/needle biopsy only if clinically indicated and scheduled for clinical purposes and testing with residual tissue for NEO100 and the major metabolite of NEO100 (Perillic Acid).

The study will use a modified Fibonacci dose titration design, followed by a standard dose escalation design.

* Cohort 1: 192 mg NEO100, QID on a 28-day cycle
* Cohort 2: 288 mg NEO100, QID on a 28-day cycle
* Cohort 3: 384 mg NEO100, TID on a 28-day cycle;
* Cohort 4 (ceiling dose): 576 mg NEO100, BID on a 28-day cycle.

Patients undergoing surgical or needle biopsy (only when clinically indicated) will receive a minimum of four days IN NEO100 treatment prior to the procedure.

NEO100 is a purified form (\>98.5%) of the naturally occurring monoterpene perillyl alcohol.

NEO100 drug product is a non-sterile solution for intranasal administration. It is compounded as a 10% solution in a 50:50 mixture of ethanol:glycerol.

NEO100

Chris Beardmore

Chloe Richmond

This is an open label, Phase 1b safety, dose-finding, brain tumor delivery, and pharmacokinetics study of intranasal NEO100 in patients with pediatric-type diffuse high grade gliomas. Patients will receive IN NEO100 that will follow a dose titration design, followed by a standard dose escalation design to establish safety. Brain tumor delivery of NEO100 will be confirmed in each disease sub-type by surgical resection/needle biopsy only if clinically indicated and scheduled for clinical purposes and testing with residual tissue for NEO100 and the major metabolite of NEO100 (Perillic Acid).

NEO100 drug product is a non-sterile solution for intranasal administration.

A feature of the clinical trials of NEO100 is to investigate the efficacy of this drug when it is delivered intranasally. Based on the general body of data on intranasal drug delivery, as well as the promising results from clinical studies in which perillyl alcohol was delivered intranasally, NeOnc expects that intranasal administration of NEO100 will allow rapid and more selective delivery of therapeutic levels of the drug to the brain, while minimizing systemic toxicity and first pass metabolism.

The study is a dose titration 1+1 design with a modified Fibonacci dose escalation, followed by a expansion design, used to determine the maximum tolerated dose and to select a recommended Phase 2 dose (RP2D). The starting dose of 192 mg mg/dose administered QID, on a 28-day cycle, is one dose below the safe dose administered to adults in a Phase 1/2a study. Dosing will increase using a modified Fibonacci dose escalation. The daily dose will start at 768 mg/day, and rise to 1,152 mg/day, which is also the safe dose administered to adults in a Phase 1/2a study.

The study is open to patient with Pediatric-type high grade glioma: Newly diagnosed and recurrent Diffuse Midline Glioma, H3 K27-altered; Diffuse hemispheric glioma, H3 G34-mutant, grade III and IV diffuse pediatric-type HGG, H3-wildtype and IDH-wildtype (including spinal cord tumors); Recurrent malignant tumors involving the brainstem or posterior fossa (choroid plexus carcinoma, CNS embryonal tumors, and pineoblastoma).

A Study of the Safety, Dosing, and Delivery of NEO100 in Patients With Pediatric Brain Tumors

An Open Label, Phase 1b Safety, Dose-finding, Brain Tumor Delivery, and Pharmacokinetics Study of Intranasal NEO100 in Patients With Pediatric-type Select Brain Tumors

Assess the safety and tolerability of increasing dose levels of intranasally administered NEO100 using the NCI CTCAE (version 5.0) for reporting of non-hematologic AEs

Assess the maximum tolerated dose (MTD) of intranasally administered NEO100 using the NCI CTCAE (version 5.0) for reporting of non-hematologic AEs

Confirm brain tumor delivery by measuring levels of NEO100 (POH) and its metabolite perillic acid (PA) in postsurgical tumor tissue in patients with pediatric-type brain tumors (measured in ng/mg).

To confirm blood brain barrier (BBB) penetration of NEO100 by measuring the concentration of NEO100 and its metabolite in resected tumor tissue.

Pharmacokinetic parameters of NEO100 metabolite perillic acid in the resected tumor tissue as measured by peak plasma concentration (Cmax).

Pharmacokinetic parameters of NEO100 metabolite perillic acid in the resected tumor tissue as measured by the time to peak plasma concentration (Tmax).

Pharmacokinetic parameters of NEO100 metabolite perillic acid in the resected tumor tissue as measured by the area under the plasma concentration vs time curve (AUC).

Objective CNS tumor response to NEO100 as determined by RANO 2.0 criteria.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MRE Evaluation for Spinal Cord Tumor Surgery: Stiffness and Adhesion Assessment	NCT05957679	Spinal Cord Tum...	Magnetic Resona... Assessment and ...	18 Years - 80 Years	Shengjing Hospital
MRE Evaluation for Spinal Cord Tumor Surgery: Stiffness and Adhesion Assessment	NCT05957679	Spinal Cord Tum...	Magnetic Resona... Assessment and ...	18 Years - 80 Years	Shengjing Hospital
A Study of the Safety, Dosing, and Delivery of NEO100 in Patients With Pediatric Brain Tumors	NCT06357377	Pediatric Tumor... Pediatric Tumor... Diffuse Midline... Pediatric Tumor... Pineocytoma Choroid Plexus ... Spinal Cord Tum... High Grade Glio...	NEO100	5 Years - 18 Years	Neonc Technologies, Inc.

Spots Global Cancer Trial Database for spinal cord tumors