NCT04579107

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: Female
• Age: 25 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-01
• Primary completion: 2024-04-01
• Completion: 2024-05-31
• First posted: 2020-10-08
• Last updated: 2023-11-18

Locations

1 site across 1 country: Sweden