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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04579107
• Other study ID #: KARMA Kontrast
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: May 31, 2024

Study information

• Verified date: November 2023
• Source: Karolinska Institutet
• Contact: Magnus Bäcklund, MD PhD
• Phone: +46704663164
• Email: magnus.backlund[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: May 31, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Previous breast cancer
• A breast biopsy performed within 6 weeks preceding the study
• Recent exposure (during the last week) to iodine contrast media.
• Pregnancy
• Current breast feeding
• Diagnosed with a pheochromocytoma or a paraganglioma
• Diagnosed with myeloma or other malignant plasma cell disease
• Diagnosed with myasthenia gravis
• A renal failure or kidney disorder with increased risk for developing renal failure (single kidney or kidney transplanted)
• Diabetes (other than dietary treated)
• Heart failure or liver failure
• Intake of potentially nephrotoxic substances (daily intake of NSAID, nephrotoxic antibiotics or nephrotoxic chemotherapy)
• Iodine contrast allergy
• Uncontrolled thyrotoxicosis
• A history of severe allergy
• Subjects unable to read, understand and execute written informed consent
• Any medical aspect that, according to the investigator, could jeopardize the health of the participant

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Country	Name	City	State
Sweden	Bröstcentrum, Södersjukhuset	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm South General Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of Contrast Enhanced Mammography	Evaluating sensitivity of Contrast Enhanced Mammography in detecting multifocality and/or contralateral breast cancer, compared to standard breast radiology work-up methods.	1 day
Secondary	Specificity of Contrast Enhanced Mammography	Estimate the specificity of Contrast Enhanced Mammography in detecting absence of breast cancer, compared to standard breast radiology work-up methods.	1 day
Secondary	Safety of Contrast Enhanced Mammography	Evaluate the safety of using Contrast Enhanced Mammography, based on adverse event reporting. Potential adverse event will be collected, reported and, if necessary, intervened, on the day for the Contrast Enhanced Mammography and up to 30 days after. All adverse events will be put in to the eCRF.	30 days
Secondary	Patient acceptance of Contrast Enhanced Mammography	Evaluate the acceptance in patients, based on a questionnaire at the end of the study visit and structured telephone interviews 1-2 weeks after. The answers to the questionnaire is on a 5-grade scale. The interviews will go deeper and summaries of the answers will be put in to the eCRF.	30 days
Secondary	Tumor size assessment	Comparing Contrast Enhanced Mammography with each standard breast radiology work-up method for tumor size assessment.	1 day
Secondary	Mammographic density influence on the performance of Contrast Enhanced Mammography	Evaluate if mammographic density influences the performance of Contrast Enhanced Mammography compared to standard breast radiology work-up methods.	1 day
Secondary	Contrast Enhanced Mammography costs	Calculate the costs for using Contrast Enhanced Mammography	1 day

External Links

•   Research group web page