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New Techniques to evAlUate Response to neOadjuvant Treatments in bReast cAncer (AURORA)

NCT04795349 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-03-12

No results posted yet for this study

Summary

The role of neoadjuvant chemotherapy (NAC) in breast cancer is well established. Increasing rates of pathologic complete response (pCR) has increased de-escalation of surgical techniques. The objective of the study is to evaluate new radiologic techniques that can accurately detect complete response in order to eliminate breast surgery. . . Currently, there are several imaging techniques for NAC response assessment (magnetic resonance imaging -MRI-, mammography and ultrasound), with good correlation in partial response, but they lack power in predicting complete pathological response. The investigators propose to use IVIM (Intravoxel incoherent motion), Kurtosis (DKI by Diffusion Kurtosis imaging) and diffusion tensor image (DTI) in MRI, contrast enhancement mammography and shear wave elastography for the evaluation of the response to systemic treatment in breast cancer patients. In order to validate the technique, in those patients with a radiological complete response by all the radiological imaging methods, a vacuum-assisted biopsy will be performed before surgery. After that, a comparison will be done between the results of the pre surgical biopsy and the definitive pathology of the specimen. So the investigators can evaluate if patients with complete radiological response after NAC, can be spared breast surgery.

Conditions

Interventions

PROCEDURE

Vacuum-assisted breast biopsy

In those patients with a radiological complete response by all the radiological imaging methods, a stereotactic biopsy will be performed before surgery. After that, a comparison will be done between the results of the pre surgical biopsy and the definitive pathology of the specimen.

Sponsors & Collaborators

  • Clinica Universidad de Navarra, Universidad de Navarra

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04795349 on ClinicalTrials.gov