Breast CancerNCT07441330
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
A study testing Breast ultrasound, MRI and TEP-TDM in people with Breast Cancer, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breast ultrasound, MRI and TEP-TDM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2022to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Breast ultrasound, MRI, TEP-TDM
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast ultrasoundProcedure or surgery
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
MRIProcedure or surgery
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
TEP-TDMProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Patient with breast cancer | Experimental | patient with locally advanced invasive breast cancer for whom neoadjuvant chemotherapy is scheduled Receives: Procedure: Breast ultrasound; Procedure: MRI; Procedure: TEP-TDM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start31 Mar 2022
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Why it stopped: difficulty in including patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441330
- Sponsor's protocol ID
- 2021-A01207-34
- Status last verified
- Jul 2026
- First submitted
- 19 Feb 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07441330
- Acronym / sponsor ID
- 2021-A01207-34
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty in including patients
- Enrolment
- 42 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with breast cancer | Experimental | Procedure: Breast ultrasound, Procedure: MRI, Procedure: TEP-TDMpatient with locally advanced invasive breast cancer for whom neoadjuvant chemotherapy is scheduled |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast ultrasoundThe 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 or surgery | Patient with breast cancer |
| MRIThe 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 or surgery | Patient with breast cancer |
| TEP-TDMThe 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 | Procedure or surgery | Patient with breast cancer |
Primary outcome
Measure of the longest axis of the tumor with breast ultrasound
Time frame: 13 months
Comparing data collected from each of the 3 imaging techniques and histological data of the excised tumor at the time of surgery
Measure of the longest axis of the tumor with MRI
Time frame: 13 months
Comparing data collected from each of the 3 imaging techniques and histological data of the excised tumor at the time of surgery
Measure of the longest axis of the tumor with TEP-TDM
Time frame: 13 months
Comparing data collected from each of the 3 imaging techniques and histological data of the excised tumor at the time of surgery
Measure of the longest axis of the excised tumor at the time of the surgery
Time frame: 13 months
Comparing data collected from each of the 3 imaging techniques and histological data of the excised tumor at the time of surgery
Results and safety
The study was stopped early (reason given: difficulty in including patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast ultrasound, MRI and TEP-TDM in people with Breast Cancer, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: difficulty in including patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of the longest axis of the tumor with breast ultrasound (time frame: 13 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.