SpagoPix - Improved Precision in Breast Cancer Diagnostics
Spago Nanomedical’s most advanced project is SpagoPix, a gadolinium-free MRI contrast agent for the diagnosis of solid tumors.
The SpagoPix project aims to launch a ground-breaking gadolinium-free MRI contrast agent for visualization of tumors and metastases. Unlike the conventional low molecular-weight MRI contrast agents, which enhance healthy tissue as well and therefore results in a relatively high proportion of false positive findings, Spago’s proprietary contrast agent is designed to selectively accumulate in tumor tissue. This improves the precision of MRI scans for suspected cancers.
Ongoing Trial in Breast Cancer Patients
With better cancer diagnostics, the chances of successful and cost-efficient treatment of cancer patients improve. In the currently ongoing SPAGOPIX-01 trial (ClinicalTrials.gov Identifier: NCT04080024), which aims at assessing safety and tolerability as well as initial efficacy of SpagoPix, the product candidate SN132D is administered to breast cancer patients at Uppsala university hospital and Sahlgrenska university hospital.
FACTS – Breast Cancer and MRI
Based on statistics released by the WHO in late 2020 with around 2.3 million new cases, breast cancer has now overtaken lung cancer as the world’s most commonly diagnosed cancer. In Sweden, one out of every nine women develops breast cancer before the age of 75. When detected early, the possibilities of successful breast cancer treatment are very good, and survival rates are therefore high. In many cases however, and especially in low-and mid-income countries, the breast cancer is often diagnosed at an advanced stage when the cancer has already spread and is usually incurable.
Image-based technologies that are used to diagnose cancer include mammography, ultrasound, computed tomography (CT), positron emission tomography (PET) and magnetic resonance imaging (MRI). MRI is primarily used within breast cancer diagnostics to provide in-depth knowledge of the localization and spread of the tumors before surgical treatment, and as a follow-up instrument to assess the outcome of treatment. One of the advantages of MRI compared with, e.g., CT and PET, which are other highly sensitive alternatives for tumor detection, is that MRI does not involve the use of ionizing radiation which in itself is a risk factor for cancer.
While MRI has significant potential to improve cancer diagnostics, the method as it is currently used has limitations which hinders the full exploitation of this sensitive means of cancer imaging. One of them is that the contrast agents which are necessary to enhance tumor contrast in the MRI imaging cannot satisfactorily distinguish cancer from non-cancer tissue which leads to a high proportion of false positive findings (tumor findings that are not malignant). False positive findings lead not only to anxiety and suffering for the individual patient, but also to significant costs for subsequent unnecessary examinations. Another factor reducing the potential for MRI is a correlation found between the use of gadolinium-based contrast agents and accumulation of gadolinium, in tissues including the brain. It is not clear whether these gadolinium deposits are harmful, but this has had a major impact on the use of these contrast agents, with authorities in the EU and the US (EMA and FDA respectively) deciding to completely ban many gadolinium-based contrast agents, or in some cases severely limit their use.