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PET/CT in the Evaluation of Locally Advanced Breast Cancer
Closed for proposals
Project Type
Project Code
E13044CRP
2052Approved Date
Status
Start Date
Expected End Date
Completed Date
9 October 2024Participating Countries
Description
Locally advanced breast cancer (LABC) is a leading cause of cancer related morbidity and mortality in many Member States. In many low-and middle-income countries approximately 45% of patients present with LABC, and most of them undergo neoadjuvant chemotherapy (NAC), which is defined as any pharmacological treatment given before primary therapy (surgery), and administered for 4 to 6 months, with an intent to downstage (reduce) the tumour so patients can become candidates for surgery. Mammography and ultrasound are the diagnostic imaging modalities most commonly used for the initial evaluation of LABC whilst MRI is used to establish the extent of the disease and for the assessment of NAC response. 18F-Fluorodeoxyglucose (18F-FDG) PET/CT is a functional imaging modality, which has shown similar efficacy to MRI in NAC assessment in multiple single centre small studies. In the last few years a new dedicated breast PET scanner, also known as PEM (positron emission mammography) has emerged as a promising imaging device. This equipment has higher special resolution than the regular PET scanners and lower cost. It can be used for assessment of response to NAC. There are no multi centric, multinational prospective comparative studies published to establish the efficacy of MRI, versus whole body PET/CT and versus dedicated breast PET. Efficacy is defined as the capacity for beneficial change of a given intervention. This CRP aims to prospectively investigate the diagnostic accuracy of MRI versus whole body PET/CT and dedicated breast PET (PEM) for assessment of response to neoadjuvant chemotherapy in locally advanced breast cancer patients with pathologic response as reference standard. Accurate pathological diagnosis of tumour mass before treatment and careful examination of specimens after treatment are two main objectives in the diagnostic process of neoadjuvant-treated breast cancer. To achieve the first objective, multiple core biopsies can be taken to assess intratumour heterogeneity. This three-year Coordinated Research Project entitled “Locally Advanced Breast Cancer Neoadjuvant Chemotherapy Assessment: A prospective comparative effectiveness study of MRI versus whole body PET/CT versus dedicated breast PET” will be conducted by the Section of Nuclear Medicine and Diagnostic Imaging (NMDI) from the Division of Human Health (NAHU). In order to be able to select the research centres that have the required infrastructure to participate in the above mentioned CRP, a survey that must be completed by centres interested in participating has been developed and should be completed by applicants.
Objectives
To establish the diagnostic accuracy of 18F-FDG whole body PET/CT and the dedicated breast PET (PEM) as compared to MRI for neoadjuvant chemotherapy assessment in locally advanced breast cancer.
Specific objectives
To establish the prognostic value of 18F-FDG dedicated breast PET; 18F-FDG whole body PET/CT and MRI in the evaluation of response to NAC in patients with LABC for two year progression free or overall survival
To establish the sensitivity and specificity of 18F-FDG whole body PET/CT as compared to MRI for neoadjuvant chemotherapy assessment in locally advanced breast cancer
To establish the sensitivity and specificity of 18F-FDG dedicated breast PET as compared to MRI for neoadjuvant chemotherapy assessment in locally advanced breast cancer
Standardization of clinical protocols for breast MRI, 18F-FDG whole-body PET/CT and 18F-FDG dedicated breast PET in participating centres
To establish the prognostic value of 18F-FDG dedicated breast PET; 18F-FDG whole body PET/CT and MRI in the evaluation of response to NAC in patients with LABC for two year progression free or overall survival
To establish the sensitivity and specificity of 18F-FDG whole body PET/CT as compared to MRI for neoadjuvant chemotherapy assessment in locally advanced breast cancer
To establish the sensitivity and specificity of 18F-FDG dedicated breast PET as compared to MRI for neoadjuvant chemotherapy assessment in locally advanced breast cancer
Standardization of clinical protocols for breast MRI, 18F-FDG whole-body PET/CT and 18F-FDG dedicated breast PET in participating centres
Impact
The Coordinated Research Project E13044 aimed to evaluate the effectiveness of dedicated breast PET using 18F-FDG compared to whole-body PET/CT and MRI in assessing the response to neoadjuvant chemotherapy (NAC) in patients with locally advanced breast cancer (LABC). Here are some potential impacts of this research:
Diagnostic Accuracy: By comparing different imaging modalities, the project could identify which method provides the most accurate assessment of tumour response, potentially leading to better treatment decisions.
Tailored Treatments: Improved imaging could allow for more personalized treatment plans based on how well a tumour responds to NAC, possibly reducing overtreatment or undertreatment.
Resource Optimization: Understanding the most effective imaging technique may help optimize resource use in clinical settings, potentially reducing costs and improving patient care efficiency.
Guidelines Development: Findings could inform clinical guidelines and standards for imaging in the context of NAC, influencing practice patterns among oncologists, nuclear medicine physicians and radiologists.
Research Opportunities: The results may open new avenues for research, such as exploring other biomarkers or imaging techniques in breast cancer response assessment.
Patient Outcomes: Ultimately, improved imaging techniques may lead to better patient outcomes, including survival rates and quality of life for those with LABC.
Overall, the project could significantly enhance the understanding and management of breast cancer treatment response.
Relevance
The relevance of the Coordinated Research Project E13044 lies in several key areas:
Targeted Imaging
Dedicated breast PET using 18F-FDG offers a focused approach to imaging, concentrating specifically on breast tissue. This specialization may enhance the sensitivity (ability to correctly identify those with the disease) and specificity (ability to correctly identify those without the disease) when detecting changes in tumour size and metabolic activity during neoadjuvant chemotherapy (NAC). Improved imaging accuracy can lead to earlier detection of treatment response, enabling timely adjustments to therapy. This could significantly impact patient management by providing clearer insights into the effectiveness of chemotherapy before surgery.
Comparative Analysis
The project's comparative analysis of dedicated breast PET, whole-body PET/CT, and MRI addresses a critical gap in clinical knowledge regarding the optimal imaging modality for evaluating treatment response in breast cancer. By systematically comparing these techniques, the project aims to identify the most effective option for clinicians. This evidence-based approach can guide decision-making, ensuring that patients receive the most appropriate and effective imaging assessments, which is crucial for tailoring treatment strategies.
Impact on Treatment Strategies
Understanding how well tumours respond to NAC is vital for determining subsequent treatment decisions. For instance, if imaging indicates a strong response, clinicians may opt to proceed with surgery sooner or reduce the intensity of subsequent chemotherapy. Conversely, if the response is suboptimal, adjustments may be necessary, such as changing to a different chemotherapy regimen or considering additional treatments like targeted therapy or radiation. These decisions directly affect patient outcomes, including survival rates and quality of life, making this research particularly impactful.
Clinical Relevance
Locally advanced breast cancer (LABC) presents significant challenges due to its aggressive nature and the complexities of treatment. Effective imaging plays a crucial role in the management of LABC by enabling precise monitoring of tumour response to NAC. Enhanced imaging capabilities can assist clinicians in navigating the complexities of treatment planning, thereby improving survival rates and quality of life for patients. Accurate assessments of treatment efficacy can lead to more informed decisions, reducing unnecessary interventions and associated side effects.
Guidelines and Protocols
The findings from this project could significantly contribute to the development of standardized protocols for imaging in the context of NAC for breast cancer. By establishing clear guidelines based on comparative effectiveness, the project can enhance consistency in clinical practice, leading to more uniform patient care. Standardized imaging protocols can also facilitate better communication among healthcare providers, ultimately benefiting patient outcomes through coordinated and efficient care.
Research and Innovation
This project has the potential to stimulate further research into novel imaging techniques and the integration of biomarkers that could enhance breast cancer diagnostics. As the field of oncology continues to evolve, advancements in imaging technology and methodologies are crucial for improving treatment monitoring and patient care. The insights gained from E13044 may pave the way for innovative approaches in imaging and treatment, contributing to the ongoing quest for precision medicine in breast cancer management.
Conclusion
Overall, the relevance of the Coordinated Research Project E13044 is multifaceted, aiming to enhance the precision and effectiveness of breast cancer treatment evaluation. By focusing on targeted imaging, conducting comparative analyses, and influencing treatment strategies, the project seeks to improve patient care and outcomes significantly. The findings could have a lasting impact on clinical practices, paving the way for advancements in breast cancer diagnosis and treatment monitoring.