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COMPLETED
NCT04579107
NA

KARMA Kontrast Evaluating Contrast Enhanced Mammography in Early Detection of Breast Cancer

Sponsor: Karolinska Institutet

View on ClinicalTrials.gov

Summary

Women taking part in the National Mammography Screening Program, examined at Södersjukhuset Breast Centre at Södra station in Stockholm and recalled because of suspicion of breast cancer will be invited to participate. A Contrast Enhanced Mammography will be added to the standard of care procedures for investigating a suspicion of breast cancer and blinded from each other 2 radiologists will evaluate either the Contrast Enhanced Mammography or the standard of care examinations. When comparing the potentially extra findings with Contrast Enhanced Mammography will be calculated. Potential side effects together with the patient experience will also be evaluated.

Official title: KARMA Kontrast - a Controlled Clinical Trial Evaluating Contrast Enhanced Mammography in Early Detection of Breast Cancer

Key Details

Gender

FEMALE

Age Range

25 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2021-10-01

Completion Date

2024-12-12

Last Updated

2026-08-26

Healthy Volunteers

No

Conditions

Interventions

COMBINATION_PRODUCT

Contrast Enhanced Mammography

A modality for examining breast conditions which is already approved and used but the evaluation of its role in a recalled screening population is limited. Intravenous iodine contrast is given prior to the mammogram.

Locations (1)

Bröstcentrum, Södersjukhuset

Stockholm, Sweden