Spots Global Cancer Trial Database for Added Value of Preoperative Contrast Enhanced Mammography in Staging of Malignant Breast Lesions
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Trial Identification
Brief Title: 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 ID: NCT04437602
Conditions
Interventions
Study Description
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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Halland Hospital Halmstad, Halmstad, , Sweden
Helsingborg Hospital, Helsingborg, , Sweden
Central Hospital Kristianstad, Kristianstad, , Sweden
Contact Details
Name: Kristina Ahsberg, PhD
Affiliation: Region Halland
Role: PRINCIPAL_INVESTIGATOR
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