Clinical trial NCT04437602: Added Value of Preoperative Contrast Enhanced Mammography in Staging of Malignant Breast Lesions
Official title: Added Value of Preoperative Contrast Enhanced Mammography (PROCEM) in Staging of Malignant Breast Lesions - a Prospective Randomized Multicenter Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Contrast Enhanced Mammography
Preoperative staging
Lead sponsor: Region Halland
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 441
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Randomized Trial
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of patients with change of primary treatment due to findings at additional CEM
timeFrame: Within two months after diagnosis of breast cancer
Secondary outcomes:
measure: Rate of reoperations
timeFrame: Within three months after diagnosis of breast cancer
measure: Rate of avoidable mastectomies
timeFrame: Within three months after diagnosis of breast cancer
Other outcomes:
Locations:
city: Halmstad
country: Sweden
facility: Halland Hospital Halmstad
city: Helsingborg
country: Sweden
facility: Helsingborg Hospital
city: Kristianstad
country: Sweden
facility: Central Hospital Kristianstad
Study officials:
affiliation: Region Halland
name: Kristina Ahsberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.