Clinical Trials

Imaging Biometrics Expanded Access Program Policy Statement

Imaging Biometrics is proud to announce that we have secured approval from the FDA for an Expanded Access Program (EAP). The EAP is open to physicians whose patients have exhausted standard-of-care therapies and fit the eligibility criteria. This program is a beacon of hope for individuals in the United States battling brain tumors who were unable to partake in our initial clinical trial at MCW.

The EAP, commonly known as ‘compassionate use,’ provides experimental treatments to patients outside of clinical trials. Governed by the FDA, the program serves as a critical pathway for those with limited or no other treatment options, offering access to potentially promising therapies prior to regulatory approval. Oral GaM has shown an impressive safety profile.

Participants in the initial trial experienced no adverse effects and the convenience of taking GaM at home further enhances patient comfort and accessibility. Physicians and patients can find more information about this program under clinicaltrials.gov (NCT06404034).

Interested in our EAP?
Contact us here.

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.

Enroll Online via ClinicalTrials.gov

414-805-8900

866-680-0505

cccto@mcw.edu

DISAPPEARING SPOON, DISAPPEARING CANCER AND THE LINK TO HEAVY METALS

Dr. Jennifer Connelly, PI of IQ-AI / Imaging Biometrics (IB) phase 1 clinical trial, gave an update on the trial's progress and future work that lies ahead.

MCW NEUROLOGY GRAND ROUNDS - JENNIFER CONNELLY - DISAPPEARING SPOON DISAPPEARING CANCER

Dr. Jennifer Connelly, MD presents the background, underlying mechanism, and clinical application of the Phase I Clinical Trial.

IQ-AI Limited shares latest progress from Phase I glioblastoma clinical trial

Dr Jennifer Connelly, the Principal Investigator (PI) of the IQ-AI Limited sponsored Phase I Clinical Trial that is being conducted at the Medical College of Wisconsin, joins Proactive's Natalie Stoberman to discuss the latest updates from its treatment for recurring glioblastoma patients.

IQ-AI Ltd, the parent company of Wisconsin-based Imaging Biometrics, LLC (IB), is focused on delivering quantitative imaging platforms and therapeutics that transform how clinicians diagnose and treat patients more efficiently and effectively.

IQAI (Imaging Biometrics) GBM BRAIN CANCER CLINICAL TRIAL

Dr. Jennifer Connelly, MD, PI of the phase I clinical trial being conducted at the Medical College of Wisconsin (MCW), shares the progress of the trial focused on combating glioblastoma multiforme (GBM) using an oral (pill) agent.