Enhancing Breast Cancer Outcomes with Medical Imaging in Clinical Trials
Medical imaging is integral to the evolution of breast cancer clinical trials providing crucial insights into tumor detection and treatment evaluation. Mammography and ultrasound are the standard imaging modalities for screening and initial diagnosis, MRI helps determine the extent of the disease after diagnosis. CT and PET/CT are also critical for staging, assessing treatment response, or detecting recurrence. The use of imaging modalities not only improves patient outcomes but also accelerates the development of new therapies, making imaging indispensable in clinical research.
Breast cancer is one of the most common cancer among women, affecting more than 2.3 million women globally. The cancer cells can be activated by hormones such as estrogen and progesterone or can also be fueled by proteins such as the human epidermal growth factor, helping determine ER (Estrogen receptor), PR (Progesterone receptor) and HER (Human epidermal growth factor receptor 2) status. This shifts the field towards personalized treatment. Imaging plays a critical role in aligning clinical trials with patient-specific needs, ensuring that treatments are as effective as possible.
The application of medical imaging in clinical trials differs significantly from its use in routine clinical settings, with RECIST 1.1 being the most commonly used criteria to assess the efficacy of new treatments. Trials often employ BICR (Blinded Independent Central Review) to ensure standardized, quantitative, and unbiased tumor assessments. Utilizing RECIST 1.1 for registrational trials allows the incorporation of PET/CT to provide a more accurate analysis of metastatic lymph nodes and predict disease progression. Yet, it is critical to correctly implement the RECIST 1.1 criteria and use the right modalities based on the specific patient population and trial design. Recent clinical trials have also assessed the sensitivity and specificity of imaging modalities by comparing breast MRI with FDG PET/CT. Trials may achieve even more dynamic results by incorporating PET/MRI.
Imaging Endpoints stands at the forefront of breast cancer clinical trials, setting new standards in imaging precision and efficacy. By incorporating innovative imaging techniques and assessments with critical clarifications and modifications to the standard RECIST 1.1 criteria, IE optimizes trial outcomes and advances the development of breakthrough therapies. As clinical trials increasingly rely on imaging, IE’s leadership remains crucial in driving progress and improving patient outcomes.
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