Breast CancerCERePredNCT06299202
Contrast-enhanced Spectral Mammography (CESM) Early Quantitative Evaluation of Tumoral Response and Pathologic Complete Response Prediction for Localized Breast Cancer Treated by Neoadjuvant Chemotherapy
A study testing Diagnostic test in people with Breast Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Some types of localised breast cancer, including stage II and III, HER2 positive (Human Epidermal Growth Factor Receptor) or triple negative cancers are treated with primary or neoadjuvant chemotherapy prior to surgical treatment (mastectomy or conservative treatment). Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Diagnostic test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 23 Aug 2024to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With a histological diagnosis of stage II or III localised breast cancer, with an indication for first or neoadjuvant chemotherapy validated by the RCP: HER2+, Triple negative
- Affiliated or beneficiary of a social security scheme or similar
- Having signed an informed consent for participation in the study.
Who cannot join
- Patients considered to be at very high risk (BRCA 1 and 2 mutation, Li Fraumeni syndrome, Lynch syndrome, previous thoracic irradiation for lymphoma) and high genetic risk as determined by an oncogenetic consultation
- Pregnancy, breastfeeding
- Contraindication to the injection of iodinated contrast material: hypersensitivity to the active substance or to one of the excipients of the contrast material, renal insufficiency with glomerular filtration rate < 35ml/min
- Patients who do not master the French language
- Patient who is an adult protected by law, under curatorship or guardianship
- Patient who has participated in another research study with a current exclusion period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital de la Croix Rousse
Lyon, 69004
Dorothée TACONET, MD, 0426109185 ext. +33, dorothee.taconet@chu-lyon.fr
About this study
Some types of localised breast cancer, including stage II and III, HER2 positive (Human Epidermal Growth Factor Receptor) or triple negative cancers are treated with primary or neoadjuvant chemotherapy prior to surgical treatment (mastectomy or conservative treatment).
Follow-up with neoadjuvant or primary chemotherapy is usually done by breast Magnetic Resonance Imaging (MRI).Tumour response to treatment is assessed on morphological size criteria.
Read more
Angiomammography (also called CESM : Contrast Enhanced Spectral Mammography) is an innovative and validated imaging technique consisting of dual energy mammography with injection of iodinated contrast medium; two images are generated, one comparable to a standard mammography and a second image highlighting the structures enhanced by the contrast medium. The characteristic neo angiogenesis of the tumour process thus allows good visualisation of the tumour compared to the underlying mammary gland.
A classical morphological analysis is therefore possible thanks to standard mammographic acquisition coupled with a quantitative functional analysis linked to the study of enhancement.
During angiomammography, several images are acquired in succession, starting with the cranio caudal view and ending with the profile view. On the same examination, these acquisitions are carried out at different injection times, making it possible to study the type of enhancement of a given area (Progressive/ Plateau/ Wash out).
Angiomammography has several advantages over breast MRI in the follow-up of chemotherapy: shorter examination time, shorter appointment time, better tolerated by the patients and without injection of Gadolinium chelates, which have recently been shown to cause definitive brain deposits during repeated injections. Currently, angiomammography is validated in the follow-up of breast cancers treated with neoadjuvant or primary chemotherapy, with an analysis of tumour response currently only morphological, as in breast MRI.
Here, the hypothesis is that the study of tumour enhancement by angiomammography may constitute a new predictive element of histological response: indeed, the performance of an initial angiomammography before treatment (baseline) and then a second angiomammography performed early in relation to the start of chemotherapy, could allow early prediction of which patients will have a complete histological response at the time of the closing surgery. This prospective study is to compare the variation in tumour enhancement, assessed on each of the two examinations using dedicated X-ray consoles, to the final histological result after closure surgery: it is hoped that the relative variation in tumour enhancement would be greater in responding patients.
- Conditions
- Breast Cancer
- Being tested
- Diagnostic test
- Keywords
- Breast cancer, Contrast Enhanced Spectral Mamography, Neodjuvant chemotherapy, Quantitative analysis, Complete histological response
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic testDiagnostic test
- Inclusion visit (V1) Initial baseline CESM (V2) 15 days after inclusion
- First chemotherapy treatment (V3) 28 days after V2.
- Unilateral follow-up CESM (V4) 4 to 6 weeks after the first course of chemotherapy.
- Surgery (V5): 3 to 6 weeks later at the end of the complete treatment with primary chemotherapy
- End of research visit (V6) It corresponds to the histological analysis on the surgical specimen after the complete treatment with neoadjuvant or primary chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Patients with localized breast cancer | Experimental | Patients with localized breast cancer (stage II or III, HER 2, triple-negative) eligible for a neoadjuvant chemotherapy and not presenting contraindication to angiomammography. Receives: Diagnostic Test: Diagnostic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evolution of the relative tumor enhancement (RTEe) (%) between the baseline and early re-evaluation CESM
Evolution of the relative tumor enhancement (RTEe) between the baseline and early re-evaluation CESM (4-6 weeks after the start of chemotherapy). That is, the percentage of post-chemo tumor enhancement - Percentage of pre-chemo tumor enhancement / pre-chemo tumor enhancement
The relative tumor enhancement (RTE) will be calculated as follows on each CESM (baseline and early follow up):
RTE = (ROI 1 - ROI 2) / ROI 2
The evolution of relative tumor enhancement (RTEe) between the initial CESM (RTEi) and the early follow-up CESM (RTEf) will be calculated.
RTEe = (RTEf) - (RTEi) / (RTEi)
Measured: At baseline, 2 and 8 months
Secondary outcomes (2)
RTEe according to the 3 categories of RCB score
Evolution of the relative tumor enhancement (RTEe) according to:
- RCB I: Minimal residual tumour
- RCB II: Moderate response
- RCB III: extensive residual tumour
Measured: At 8 months
The type of enhancement (TE) %
The type of enhancement (%) will be calculated at each CESM (initial and follow-up) as follows :
signal-to-noise ratio (SNR) on the late image - SNR on the early image / SNR on the late image.
Measured: At baseline and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start23 Aug 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
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.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299202
- Sponsor's protocol ID
- 69HCL23_0204
- Other IDs
- ID-RCB
- Acronym
- CERePred
- Status last verified
- Sep 2024
- First submitted
- 19 Feb 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-enhanced Spectral Mammography (CESM) Early Quantitative Evaluation of Tumoral Response and Pathologic Complete Response Prediction for Localized Breast Cancer Treated by Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT06299202
- Acronym / sponsor ID
- CERePred / 69HCL23_0204
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Contrast Enhanced Spectral Mamography, Neodjuvant chemotherapy, Quantitative analysis, Complete histological response
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 Aug 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 7 Mar 2024 (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.
Some types of localised breast cancer, including stage II and III, HER2 positive (Human Epidermal Growth Factor Receptor) or triple negative cancers are treated with primary or neoadjuvant chemotherapy prior to surgical treatment (mastectomy or conservative treatment).
Follow-up with neoadjuvant or primary chemotherapy is usually done by breast Magnetic Resonance Imaging (MRI).Tumour response to treatment is assessed on morphological size criteria.
Angiomammography (also called CESM : Contrast Enhanced Spectral Mammography) is an innovative and validated imaging technique consisting of dual energy mammography with injection of iodinated contrast medium; two images are generated, one comparable to a standard mammography and a second image highlighting the structures enhanced by the contrast medium. The characteristic neo angiogenesis of the tumour process thus allows good visualisation of the tumour compared to the underlying mammary gland.
A classical morphological analysis is therefore possible thanks to standard mammographic acquisition coupled with a quantitative functional analysis linked to the study of enhancement.
During angiomammography, several images are acquired in succession, starting with the cranio caudal view and ending with the profile view. On the same examination, these acquisitions are carried out at different injection times, making it possible to study the type of enhancement of a given area (Progressive/ Plateau/ Wash out).
Angiomammography has several advantages over breast MRI in the follow-up of chemotherapy: shorter examination time, shorter appointment time, better tolerated by the patients and without injection of Gadolinium chelates, which have recently been shown to cause definitive brain deposits during repeated injections. Currently, angiomammography is validated in the follow-up of breast cancers treated with neoadjuvant or primary chemotherapy, with an analysis of tumour response currently only morphological, as in breast MRI.
Here, the hypothesis is that the study of tumour enhancement by angiomammography may constitute a new predictive element of histological response: indeed, the performance of an initial angiomammography before treatment (baseline) and then a second angiomammography performed early in relation to the start of chemotherapy, could allow early prediction of which patients will have a complete histological response at the time of the closing surgery. This prospective study is to compare the variation in tumour enhancement, assessed on each of the two examinations using dedicated X-ray consoles, to the final histological result after closure surgery: it is hoped that the relative variation in tumour enhancement would be greater in responding patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with localized breast cancer | Experimental | Diagnostic Test: Diagnostic testPatients with localized breast cancer (stage II or III, HER 2, triple-negative) eligible for a neoadjuvant chemotherapy and not presenting contraindication to angiomammography. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- With a histological diagnosis of stage II or III localised breast cancer, with an indication for first or neoadjuvant chemotherapy validated by the RCP: HER2+, Triple negative
- Affiliated or beneficiary of a social security scheme or similar
- Having signed an informed consent for participation in the study.
Key exclusion criteria (6 listed)
- Patients considered to be at very high risk (BRCA 1 and 2 mutation, Li Fraumeni syndrome, Lynch syndrome, previous thoracic irradiation for lymphoma) and high genetic risk as determined by an oncogenetic consultation
- Pregnancy, breastfeeding
- Contraindication to the injection of iodinated contrast material: hypersensitivity to the active substance or to one of the excipients of the contrast material, renal insufficiency with glomerular filtration rate < 35ml/min
- Patients who do not master the French language
- Patient who is an adult protected by law, under curatorship or guardianship
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 |
|---|---|---|
| Diagnostic test* Inclusion visit (V1) Initial baseline CESM (V2) 15 days after inclusion * First chemotherapy treatment (V3) 28 days after V2. * Unilateral follow-up CESM (V4) 4 to 6 weeks after the first course of chemotherapy. * Surgery (V5): 3 to 6 weeks later at the end of the complete treatment with primary chemotherapy * End of research visit (V6) It corresponds to the histological analysis on the surgical specimen after the complete treatment with neoadjuvant or primary chemotherapy. | Diagnostic test | Patients with localized breast cancer |
Primary outcome
The evolution of the relative tumor enhancement (RTEe) (%) between the baseline and early re-evaluation CESM
Time frame: At baseline, 2 and 8 months
Evolution of the relative tumor enhancement (RTEe) between the baseline and early re-evaluation CESM (4-6 weeks after the start of chemotherapy). That is, the percentage of post-chemo tumor enhancement - Percentage of pre-chemo tumor enhancement / pre-chemo tumor enhancement The relative tumor enhancement (RTE) will be calculated as follows on each CESM (baseline and early follow up): RTE = (ROI 1 - ROI 2) / ROI 2 The evolution of relative tumor enhancement (RTEe) between the initial CESM (RTEi) and the early follow-up CESM (RTEf) will be calculated. RTEe = (RTEf) - (RTEi) / (RTEi)
2 secondary outcomes
RTEe according to the 3 categories of RCB score
Time frame: At 8 months
The type of enhancement (TE) %
Time frame: At baseline and 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic test in people with Breast Cancer, run by Hospices Civils de Lyon 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 27 Sep 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dorothée TACONET, MD (0426109185 ext. +33, dorothee.taconet@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The evolution of the relative tumor enhancement (RTEe) (%) between the baseline and early re-evaluation CESM (time frame: At baseline, 2 and 8 months). 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 27 Sep 2024.