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

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 25
Maximum Age: 85
Healthy Volunteers: f
View:

• Female

• Age: \>25 - \<85 years

• Recalled after Mx screening based on abnormal mammographic findings or refered for breast cancer related symtoms

• The woman has read, understood and signed the Informed Consent Form (ICF)

Locations
Other Locations
Sweden
Bröstcentrum, Södersjukhuset
RECRUITING
Stockholm
Contact Information
Primary
Magnus Bäcklund, MD PhD
magnus.backlund@ki.se
+46704663164
Backup
Per Hall, MD PhD
per.hall@ki.se
+46852480000
Time Frame
Start Date: 2021-10-01
Estimated Completion Date: 2024-05-31
Participants
Target number of participants: 420
Treatments
Other: Contrast Enhanced Mammography
All included women go through a Contrast Enhanced Mammography added to the standard of care examinations.
Related Therapeutic Areas
Sponsors
Collaborators: Stockholm South General Hospital
Leads: Karolinska Institutet

This content was sourced from clinicaltrials.gov