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

NCT07441330 | Terminated

• 1 other identifier: 2021-A01207-34
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Patient with breast cancer

EXPERIMENTAL

patient with locally advanced invasive breast cancer for whom neoadjuvant chemotherapy is scheduled

Procedure: Breast ultrasound; Procedure: MRI; Procedure: TEP-TDM

Interventions

Breast ultrasound PROCEDURE

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

Patient with breast cancer

MRI PROCEDURE

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

Patient with breast cancer

TEP-TDM PROCEDURE

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

Patient with breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patient
• 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

You may not qualify if:

• Patient with metastatic cancer
• Patient with another untreated associated cancer
• Patient already treated with CNA
• 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
• 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.

Sponsors & Collaborators

• Ramsay Générale de Santé: lead

Study Sites (1)

Hôpital Privé Paul d'Egine

Champigny-sur-Marne, 94500, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: February 27, 2026
• Study Start: March 31, 2022
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

FR (1)