Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

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Glioblastoma

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Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

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Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Brain Tumor, Adult

Neuroepithelioma

Micronutrients

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Hematinics

Pharmaceutical Solutions

Iron

Ferrosoferric Oxide

Parenteral Nutrition Solutions

Ferumoxytol is an iron replacement product that is FDA approved to treat iron deficiency anemia in patients with chronic kidney disease (CKD). In this study, ferumoxytol is used to quantify tumor-associated macrophages. The infused dose would be 5mg/kg.

All participants will receive a ferumoxtyol (Feraheme) infusion 20-28 hours prior to a head MRI. In addition, a blood draw for liquid biopsy targeted tissue sampling during surgery and special iron and macrophage staining on the tumor tissue.

Post Feraheme Infusion MRI

Seyed Ali Nabavizadeh, MD

Patients with a new diagnosis of high-grade glioma based on MRI, who are considered surgical candidates determined by neurosurgeons or patients with recurrent glioblastoma with the initial diagnosis of glioblastoma (histologic or molecular proof) and recommended for clinically surgical resection may be eligible for this study. Subjects may participate in this study if they are at least 18 years of age.

Ferumoxytol-enhanced MRI will be used to quantify tumor-associated macrophages. This is a non-therapeutic trial in that imaging will not be used to direct treatment decisions.

The blood draw is being completed to evaluate cell-free circulating tumor DNA (cfDNA) and cell-free tumor DNA (ctDNA).

This is a pilot study in subjects with a new diagnosis of high-grade glioma based on classic MRI appearance who are considered surgical candidates and patients with histologically proven diagnosis of glioblastoma (GB) who have completed chemoradiation and now have new contrast-enhancing lesions or lesions showing increased enhancement ( 25% increase) who are recommended for a clinical surgical resection. Subjects may participate in this study if they are at least 18 years of age, most participants will be receiving care at the clinical practices of the University of Pennsylvania. Subjects who come to the University of Pennsylvania for diagnosis and/or treatment of GB and who meet the study inclusion criteria may be approached by study personnel for recruitment into this study. Subjects will be approached about study participation regardless of race or ethnic background. Investigators anticipate enrolling up to 30 participants. Subjects who consent but do not complete the study imaging will be considered not evaluable and will be replaced. Accrual will likely occur over approximately 2 years. After undergoing screening assessments and verifying eligibility for study participation subjects will undergo a research ferumoxytol-enhanced MRI of the brain and blood draws for liquid biopsy.

Multimodality MRI and Liquid Biopsy in GBM

Multimodality MRI for Quantification of Tumor-associated Macrophages and Prediction of Somatic Mutation Detectability in Cell-free DNA in Adult Patients With Glioblastoma

Macrophage quantification status will be determined using histology methods based on biopsy sites and will be correlated with ferumoxytol-enhanced MRI.

To determine the proportion of mutations identified by biopsy that are correctly identified in samples of plasma ctDNA for each subject, and to explore the potential of imaging measures to predict that proportion

Abramson Cancer Center at Penn Medicine

Assistant Professor of Radiology at the Hospital of the University of Pennsylvania

Meningioma

Neoplasms, Vascular Tissue

Meningeal Neoplasms

Patients who have received permanent implants of GammaTile radiation therapy immediately following brain tumor resection.

GammaTile

Michael A. Garcia, MD, MS

Sita Patel, PhD, PharmD

John Wanebo, MD

Analiz Rodriguez, MD, PhD

Lawrence Dickinson, MD

David Piccioni, MD, PhD

Amir Lavaf, MD

Lewis Leng, MD

Angela Bohnen, MD

Vadim Tsvankin, MD

Devon Haydon, MD

Rupesh Kotecha, MD

Imran Mohiuddin, MD

Catherine Mercado, MD

Tulika Ranjan, MD

Surabhi Ranjan, MD, FACP

Adam Nowlan, MD

Kimberly Bojanowski

Ondrej Choutka

Mitesh Shah

Kushal Shah

Akshitkumar Mistry, MD

Parag Sevak, MD

Adam M Robin, MD

John Trusheim, MD

Clark Chen, MD

Michele Aizenberg, MD

Kevin Yao, MD

Dubin David, MD

Tuba Ahmed

Alexandra Paul, MD

Harish Babu, MD

Simon Hanft

Colette Shen, MD

Stuart Lee, MD

Vincent DiNapoli, MD

Mark Hoeprich, MD

Nimisha Deb, MD

Toral Patel, MD

Akash Patel, MD

David Baskin, MD

John Floyd, MD

James Zhu, M.D., Ph.D.

James Zhu, M.D., Ph.D

Huong Pham, MD

Roby Ryan, MD

The objectives of this registry study are to evaluate real-world clinical outcomes and patient reported outcomes that measure the effectiveness and safety of STaRT.

Patients (N=600) with surgically resected (R) brain tumors of any pathology who have undergone STaRT are eligible. Data collected will include local control, overall survival, QOL, neurocognition, functional decline, and surgical and radiation associated AE's. Data will be collected at 1, 3, 6, 9,12, 18 and 24 months, then every 6 months through 5 years. RESULT: Data will be used to benchmark clinical outcomes of STaRT therapy and allow for comparisons to existing standard-of-care treatments. This will be the first observational registry study of R+STaRT, delivered by Cs-131 sources in permanently implanted resorbable collagen tile carriers. The outcome measures captured will allow for evaluation of the potential risks and benefits of this treatment approach for patients in a real-world setting.

Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)

A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms

No contrast enhancement in the area of the surgical bed

Median duration of survival of subjects following surgical resection of tumor

GT Medical Technologies, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Multimodality MRI and Liquid Biopsy in GBM	NCT04776980	Glioblastoma Mu... Brain Tumor, Ad... Brain Tumor, Re... Brain Tumor, Pr...	Post Feraheme I...	18 Years -	Abramson Cancer Center at Penn Medicine
Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)	NCT04427384	Brain Tumor, Re... Brain Tumor Brain Tumor, Pr... Brain Tumor - M... Brain Tumor, Ad... Brain Tumor, Ad...	GammaTile	-	GT Medical Technologies, Inc.

Spots Global Cancer Trial Database for brain tumor, adult: glioblastoma