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Completed

NCT Number: NCT05402930

Angiomammography and Neoadjuvant Chemotherapy

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St-Sacrement Hospital

Québec, Quebec, G1S4L8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Angiomammography

Diagnostic Test

Patients will receive their care in a standard manner. Breast MRI is one modality used by physicians to monitor response to neoadjuvant chemotherapy and will therefore be used as standard. A CESM exam will be added at the same time as the MRI.

Patients will have a physical exam, breast MRI and CESM before the start of chemotherapy (less than 2 weeks). These examinations will be repeated after cycle 2 (±1 week) and at the end of chemotherapy. After each cycle of chemotherapy, the tumor will be measured in two axes by the attending physician.

Histological examination of the surgical specimen will be used to determine the pCR. Responses observed on MRI and CESM will be compared to pCR.

Primary outcomes

  1. Number of patients with a pCR accoreding to angiomammography, based on a 50% reduction in lesion size at angiomammography

    Time frame: 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

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Registry information

Official study title

Usefulness of Angiomammography for Predicting the Response to Neoadjuvant Chemotherapy in Breast Cancer

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Jun 2, 2022
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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