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临床试验/NCT06299202
NCT06299202尚未招募不适用

Contrast-enhanced Spectral Mammography (CESM) Early Quantitative Evaluation of Tumoral Response and Pathologic Complete Response Prediction for Localized Breast Cancer Treated by Neoadjuvant Chemotherapy

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
2
主要终点
The evolution of the relative tumor enhancement (RTEe) (%) between the baseline and early re-evaluation CESM

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
35 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Diagnostic test (Diagnostic Test)

结局指标

主要结局

The evolution of the relative tumor enhancement (RTEe) (%) between the baseline and early re-evaluation CESM

时间窗: 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)

次要结局

  • RTEe according to the 3 categories of RCB score(At 8 months)
  • The type of enhancement (TE) %(At baseline and 2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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