Breast Neoplasms Clinical Trial
Official title:
Usefulness of Angiomammography for Predicting the Response to Neoadjuvant Chemotherapy in Breast Cancer
Verified date | February 2024 |
Source | CHU de Quebec-Universite Laval |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The best prognostic factor following neoadjuvant chemotherapy is the pathological complete response (pCR). pCR is defined as the absence of invading cells in the breast and lymph nodes following neoadjuvant chemotherapy treatment. Since patients with pCR have a better prognosis than those without pCR, some studies have evaluated different methods to predict pCR early in treatment. Thus, patients who do not respond optimally to treatment could be identified early and changed treatment in order to maximize the chances of pCR and avoid the morbidity of poorly effective treatments. To do this, several modalities have been proposed, including MRI, mammography, ultrasound, positron emission tomography, elastography, and serial biopsies, but these techniques have shown predictive and sometimes expensive. Nevertheless, assessment of tumor response after cycle 2 has been suggested to be appropriate for the prediction of pCR. The main objective of this study is to compare the performance of two diagnostic modalities, namely CESM and MRI, in the evaluation of the response of a malignant breast tumor to neoadjuvant chemotherapy and the prediction of pCR. The radiological response will also be compared to the clinical response.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 30, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Female aged 18 and over - Histologically proven breast cancer by large gauge needle - No evidence of distant metastasis - Neoadjuvant chemotherapy with or without concomitant targeted therapy - Breast tumor initially measurable by clinical examination Exclusion Criteria: - Refusal to perform the biopsy or surgery - Pregnant or possibly pregnant woman - Usual contraindication to contrast product - Significant kidney failure - Allergy to contrast medium - frank hyperthyroidism - Usual contraindications to MRI |
Country | Name | City | State |
---|---|---|---|
Canada | St-Sacrement Hospital | Quebec City | Quebec |
Lead Sponsor | Collaborator |
---|---|
CHU de Quebec-Universite Laval |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with a pCR accoreding to angiomammography, based on a 50% reduction in lesion size at angiomammography | Prediction of pCR using angiomammography after cycle 2 of neoadjuvant chemotherapy, based on a 50% reduction in lesion size at angiomammography | Cycle 2 (each cycle being 21 days), i.e., after the chemotherapy on day 1 of cycle 2 and before cycle 3. |
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