Angiomammography and Neoadjuvant Chemotherapy

NCT ID: NCT05402930

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-03
• Study Completion Date: 2025-12-31

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.

Conditions

Breast Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neoadjuvant chemotherapy

Group Type: EXPERIMENTAL

Angiomammography

Intervention Type: 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.

Interventions

Angiomammography

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

CHU de Quebec-Universite Laval

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St-Sacrement Hospital

Québec, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Facility Contacts

Jean-Charles Hogue

Role: primary

jean-charles.hogue@crchudequebec.ulaval.ca

4185254444 ext. 82424

Other Identifiers

2019-4433

Identifier Type: -

Identifier Source: org_study_id