Added Value of Preoperative Contrast Enhanced Mammography in Staging of Malignant Breast Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

441 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-02

Study Completion Date

2029-12-31

Brief Summary

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Patients diagnosed with breast cancer after routine assessment with digital mammography and ultrasound and scheduled for primary surgery are included in the trial. The patients are randomized 1:1 to go through additional contrast enhanced mammography (CEM) or no further imaging preoperatively. Primary endpoint is rate of patients with change of treatment: a) mastectomy instead of partial mastectomy due larger unifocal or multifocal extent, b) partial mastectomy instead of mastectomy due to improved demarcation of the tumour area, c) bilateral surgery instead of unilateral due to findings of contralateral cancer, d) neoadjuvant therapy instead of primary surgery due to more advanced disease. Rate of reoperation and rate of avoidable mastectomies are secondary endpoints.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective Randomized Trial

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CEM

Patients in experimental arm will go through additional preoperative staging with contrast enhanced mammography

Group Type EXPERIMENTAL

Contrast Enhanced Mammography (CEM)

Intervention Type DIAGNOSTIC_TEST

Additional CEM in preoperative staging

No CEM

Patients in No intervention arm will go through no additional preoperative imaging

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Contrast Enhanced Mammography (CEM)

Additional CEM in preoperative staging

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Planned primary surgery for suspicious or verified breast malignancy Age of 18 years and above Signed informed consent

Exclusion Criteria

* Planned neoadjuvant therapy On-going pregnancy Iodinated contrast agent allergy Renal failure (abnormal S-creatinine) Untreated thyreotoxicosis Severe heart failure Myastenia gravis Breast implant Local recurrence as index lesion Inability to understand and comprehend oral and written information of the study

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No