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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Breast ultrasound; Procedure: MRI; Procedure: TEP-TDM

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Champigny-sur-Marne, France, 94500
    • Hôpital Privé Paul d'Egine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female patient
• Patient aged 18 years or older at the time of inclusion in the study.
• Patient with a diagnosis of advanced local invasive breast cancer, according to the TNM classification
• Patient scheduled for neoadjuvant chemotherapy after multidisciplinary tumor board meeting, and without contraindications after pre-treatment assessment
• Patient who has had a pre-cancer ultrasound, MRI, and/or PET scan
• Patient capable and willing to follow the protocol procedures according to the investigator
• Patient affiliated with or covered by a social security plan
• Patient who has given her free, informed, and explicit written consent

Exclusion Criteria:

• Patient with metastatic cancer
• Patient with another untreated associated cancer
• Patient already treated with CNA
• Patient who has been treated for cancer within the 5 years preceding their inclusion in the study
• Patient whose physical and/or psychological health is severely impaired, which, according to the investigator, may affect the participant's compliance with the study.
• Patient participating in another research study
• Patient on exclusion from another ongoing research study at the time of inclusion. Protected patient:

adult under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision.

• Pregnant, breastfeeding, or parturient woman.
• Patient hospitalized without consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patient with breast cancer; patient with locally advanced invasive breast cancer for whom neoadjuvant chemotherapy is scheduled

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of the longest axis of the tumor with breast ultrasound	Comparing data collected from each of the 3 imaging techniques and histological data of the excised tumor at the time of surgery	13 months
Measure of the longest axis of the tumor with MRI	Comparing data collected from each of the 3 imaging techniques and histological data of the excised tumor at the time of surgery	13 months
Measure of the longest axis of the tumor with TEP-TDM	Comparing data collected from each of the 3 imaging techniques and histological data of the excised tumor at the time of surgery	13 months
Measure of the longest axis of the excised tumor at the time of the surgery	Comparing data collected from each of the 3 imaging techniques and histological data of the excised tumor at the time of surgery	13 months

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 2021-A01207-34

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No