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

NCT04579107 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2023-11-18

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Per Hall, MD PhD · Karolinska Institutet

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2024-04-01
Completion
2024-05-31

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04579107 on ClinicalTrials.gov