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

Breast Cancer Clinical Trial

— PROCEM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04437602
• Other study ID #: 2019-02661
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: December 31, 2029

Study information

• Verified date: May 2024
• Source: Region Halland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 441
• Est. completion date: December 31, 2029
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Diagnostic Test:
• Contrast Enhanced Mammography (CEM)
Additional CEM in preoperative staging

Locations

Country	Name	City	State
Sweden	Halland Hospital Halmstad	Halmstad
Sweden	Helsingborg Hospital	Helsingborg
Sweden	Central Hospital Kristianstad	Kristianstad

Sponsors (1)

Lead Sponsor	Collaborator
Region Halland

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Ahsberg K, Gardfjell A, Nimeus E, Rasmussen R, Behmer C, Zackrisson S, Ryden L. Added value of contrast-enhanced mammography (CEM) in staging of malignant breast lesions-a feasibility study. World J Surg Oncol. 2020 May 21;18(1):100. doi: 10.1186/s12957-0 — View Citation

Ahsberg K, Gardfjell A, Nimeus E, Ryden L, Zackrisson S. The PROCEM study protocol: Added value of preoperative contrast-enhanced mammography in staging of malignant breast lesions - a prospective randomized multicenter study. BMC Cancer. 2021 Oct 18;21(1):1115. doi: 10.1186/s12885-021-08832-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients with change of primary treatment due to findings at additional CEM	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	Within two months after diagnosis of breast cancer
Secondary	Rate of reoperations	Number of reoperations due to inadequate margins	Within three months after diagnosis of breast cancer
Secondary	Rate of avoidable mastectomies	Patients operated with mastectomy where histopathology shows extent less than 3 cm	Within three months after diagnosis of breast cancer