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

NCT04437602 | Active Not Recruiting

• 1 other identifier: 2019-02661
• Study Type: interventional
• Target: 441
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Breast Cancer

Keywords

Contrast Enhanced Mammography; Preoperative staging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Rate of reoperations

  Within three months after diagnosis of breast cancer

• Rate of avoidable mastectomies

  Within three months after diagnosis of breast cancer

Study Arms (2)

CEM

EXPERIMENTAL

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

Diagnostic Test: Contrast Enhanced Mammography (CEM)

No CEM

NO INTERVENTION

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

Interventions

Contrast Enhanced Mammography (CEM) DIAGNOSTIC_TEST

Additional CEM in preoperative staging

CEM

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Breast cancer is very uncommon among men.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Halland: lead

Study Sites (3)

Halland Hospital Halmstad

Halmstad, 301 85, Sweden

Location

Helsingborg Hospital

Helsingborg, 252 23, Sweden

Location

Central Hospital Kristianstad

Kristianstad, 291 33, Sweden

Location

Related Publications (2)

• 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.

  PMID: 34663236 BACKGROUND

• 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/s12957-020-01865-0.

  PMID: 32438917 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Kristina Ahsberg, PhD

  Region Halland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective Randomized Trial

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 18, 2020
• Study Start: November 2, 2020
• Primary Completion: April 30, 2024
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)