Angiomammography and Neoadjuvant Chemotherapy

Not Applicable

Recruiting

• Conditions: Breast Neoplasms
• Interventions: Diagnostic Test: Angiomammography

• Registration Number: NCT05402930
• Lead Sponsor: CHU de Quebec-Universite Laval

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-03
• Study First Submitted: 2022-05-20
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-07
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neoadjuvant chemotherapy	Angiomammography	-

Primary Outcome Measures

Name	Time	Method
Number of patients with a pCR accoreding to angiomammography, 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.	Prediction of pCR using angiomammography after cycle 2 of neoadjuvant chemotherapy, based on a 50% reduction in lesion size at angiomammography

Trial Locations

Locations (1)

St-Sacrement Hospital; 🇨🇦 Quebec City, Quebec, Canada