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NCT Number: NCT04437602

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Halland Hospital Halmstad, Halmstad, Sweden

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Contrast Enhanced Mammography (CEM)

Diagnostic Test

Additional CEM in preoperative staging

Primary outcomes

  1. Rate of patients with change of primary treatment due to findings at additional CEM

    Time frame: Within two months after diagnosis of breast cancer

    Mastectomy instead of partial mastectomy due to findings of multifocal disease, mastectomy instead of partial mastectomy due to larger unifocal extent, partial mastectomy instead of mastectomy due to improved demarcation of tumour area, bilateral surgery due to findings of contralateral cancer, primary neoadjuvant treatment instead of primary surgery due to more advanced disease

Secondary outcomes

  1. Rate of reoperations

    Time frame: Within three months after diagnosis of breast cancer

    Number of reoperations due to inadequate margins

  2. Rate of avoidable mastectomies

    Time frame: Within three months after diagnosis of breast cancer

    Patients operated with mastectomy where histopathology shows extent less than 3 cm

Sponsors and collaborators

Lead sponsor

Region Halland

Other

Registry information

Official study title

Added Value of Preoperative Contrast Enhanced Mammography (PROCEM) in Staging of Malignant Breast Lesions - a Prospective Randomized Multicenter Trial

Acronym: PROCEM

Important dates

Study start
2020
Primary completion
2024
Study completion
2029
First posted
Jun 18, 2020
Registry last updated
May 7, 2024

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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