NCT07441330

Evaluation of Data Obtained From Three Common Imaging Techniques: Positron Emission Tomography (PET-CT), Breast Ultrasound, and Magnetic Resonance Imaging (MRI) After Neoadjuvant Chemotherapy in Patients With Breast Cancer

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Ramsay Générale de Santé · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Breast cancer is the most common and most deadly malignant tumor in women. In the case of invasive breast cancer, cancer cells have invaded the tissues surrounding the tumor. Neoadjuvant chemotherapy (NAC) is a therapeutic strategy used in locally advanced invasive breast cancer, with the aim of reducing tumor size in order to increase the chances of breast preservation and reduce micrometastases. Accurate and reliable assessment of the locoregional response to NAC is essential because it allows for planning whether breast-conserving surgery is necessary. Today, three minimally invasive imaging techniques are used to assess the response to NAC and the size of residual tumor: ultrasound, MRI, and PET. In routine practice, the choice of performing one, two, or three imaging techniques after NAC varies from one healthcare facility to another. Currently, there are no international recommendations, and decisions are made during multidisciplinary team meetings (MDTs), which include radiologists, oncologists, pathologists, and gynecologists. A review of the literature has not established the superiority of one technique over another in determining the size of residual tumor after neonatal ablation (NAA). Several studies analyze each technique individually, but the methodologies differ. More recent studies compare ultrasound, MRI, and PET scans, but the small number of patients and the fact that some studies are retrospective make the results inconclusive. A prospective study conducted on a large number of patients, each examined using all three techniques after NAA and before surgery, would determine the most effective technique for assessing residual tumor size and, consequently, for deciding on the surgical procedure. The main objective of this study is to compare the data collected by each of the three imaging techniques after neonatal ablation (breast ultrasound, MRI, and PET-CT) with the histological data of the tumor excised at the time of surgery.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Breast ultrasound	The following data are collected: * The largest diameter of the index lesion and satellite lesions * The largest diameter of all visible lesions * The short axis and cortical thickness of any primary lymphadenopathy * The presence or absence of lymph node involvement
PROCEDURE	MRI	The following data are collected: * Measurement of the largest diameter of the infiltrating lesion(s) corresponding on MRI to masses and enhancements, allowing assessment of the morphological response. * Evaluation of RECIST criteria * Persistence or absence of contrast enhancement * Study of the type of enhancement: mass or no mass * Study of perfusion dynamics to assess the metabolic and functional response, using the percentage of maximum enhancement. * Study of the response pattern: concentric or fragmented nature of the lesion * Presence or absence of lymph node involvement * Diffusion sequence: presence or absence of diffusion hyperintensity and calculation of the ADC
PROCEDURE	TEP-TDM	The following data are collected * The SUV max (Standardized Uptake Value maximum) corresponds to an absolute quantification of the radioactive tracer. The SUV measures the radioactive activity within cells, reflecting their metabolism. Most malignant tumor cells exhibit hypermetabolism with increased glycolysis, resulting from enhanced glucose transport capacity on the membrane and increased activity of the main enzymes controlling glycolysis. They will absorb FDG in greater quantities than normal cells and will not eliminate it. Thus, a high SUV max suggests significant uptake and therefore a malignant lesion. * The metabolic tumor volume (MTV): calculation of the volume in three dimensions of SUV space, with a value at least equal to 40% of the SUV max. * The presence or absence of lymph node involvement

Timeline

• Start date: 2022-03-31
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: France