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Angiomammography and Neoadjuvant Chemotherapy

L

Laval University

Status

Enrolling

Conditions

Breast Neoplasms

Treatments

Diagnostic Test: Angiomammography

Study type

Interventional

Funder types

Other

Identifiers

NCT05402930
2019-4433

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Neoadjuvant chemotherapy
Experimental group
Treatment:
Diagnostic Test: Angiomammography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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