Clinical Trials

Imaging Biometrics Expanded Access Program Policy Statement

Through carefully managed clinical trials, Imaging Biometrics (IB) seeks to determine whether gallium maltolate (GaM), an investigational medical product, is safe and effective for the treatment of glioblastoma.

We acknowledge that many patients are unable to participate in the clinical trials of GaM and that some of these patients may seek treatment use of the drug through Expanded Access, also known as “compassionate use”.

Because GaM is in the early stages of clinical development, it is not yet clear how safe it is in humans and whether people with glioblastoma will benefit from its use. As of the end of 2023, we have not yet launched an Expanded Access program (EAP) for GaM, and we are not accommodating individual requests for use of the drug outside of a clinical research trial or an organized EAP.

As clinical evidence accrues, we will be examining ways to make GaM available to physicians and patients who do not have access to the drug’s research trials. One path under consideration is a medium-sized cohort EAP to be opened as soon as such a program is permitted by the FDA and economically feasible for us to support. We hope to have favorable news about a GaM EAP in 2024. If you are a patient or physician who may want to participate, please use the below link/button and submit your information

PHASE 1 CLINICAL TRIAL OF GALLIUM MALTOLATE FOR THE
TREATMENT OF RELAPSED OR REFRACTORY GLIOBLASTOMA
Clinical Trial # NCT04319276

JENNIFER CONNELLY, MD (STUDY PI)
CHRISTOPHER R. CHITAMBAR, MD (STUDY CO-PI AND CHAIR)

Imaging Biometrics is currently sponsoring the clinical trial of the oral drug Gallium Maltolate for recurring glioblastoma. In addition, IB provides image analysis for evaluating the response to Gallium Maltolate treatment in patients. 

Dr. Jennifer Connelly, MD, Associate Professor of Neurology at the Medical College of Wisconsin, is the Principal Investigator of the clinical trial with Dr. Christopher Chitambar, MD, serving as co-PI and Chair. Both are long-standing collaborators with Dr. Kathleen Schmainda, PhD, a co-founder of Imaging Biometrics, LLC, and a recognized leader in brain tumor imaging. 

The treatment evolved from research led by Dr. Chitambar and his lab to study iron-dependent processes in cancer biology and the mechanisms by which gallium compounds target iron metabolism and block malignant cell growth. In preclinical studies, Dr. Chitambar and Dr. Schmainda, discovered that when administered intravenously, Gallium Maltolate (GaM) significantly slowed the growth of glioblastoma in a rat brain tumor model. Additional studies showed that GaM, administered orally to glioblastoma-bearing rats, significantly reduced the size of their tumors and prolonged survival.

GaM is an orally available form of the metal gallium, which, in the body, shares many chemical properties with the highly oxidized form of iron, Fe(III). Numerous studies examining the relationship between iron and cancer show that increased levels of iron in the body can be associated with increased cancer risk and severity, due to cancer cells' dependence on iron to multiply and spread. Cancer cells take up gallium instead of iron, preventing their multiplication, ultimately leading to their death.

The trial, being conducted at Froedtert & the Medical College of Wisconsin, is currently accepting participants and has an anticipated completion date of December 2025.

Enrollment Information

For more information, visit ClinicalTrials.gov or contact The Medical College of Wisconsin Cancer Center Clinical Trials Office by phone or email.

To contact Imaging Biometrics directly, please visit our Contact Page.

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