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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Combination product: Contrast Enhanced Mammography

• Study Type: Interventional
• Enrollment (Estimated): 420
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Magnus Bäcklund, MD PhD; Phone Number: +46704663164; Email: magnus.backlund@ki.se
• Study Contact Backup: Name: Per Hall, MD PhD; Phone Number: +46852486152 +46852480000; Email: per.hall@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Bröstcentrum, Södersjukhuset
    • Contact: Magnus Bäcklund, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 59 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Contrast Enhanced Mammography; All included women go through a Contrast Enhanced Mammography added to the standard of care examinations.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Tumor size assessment	Comparing Contrast Enhanced Mammography with each standard breast radiology work-up method for tumor size assessment.	1 day
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
Contrast Enhanced Mammography costs	Calculate the costs for using Contrast Enhanced Mammography	1 day

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Stockholm South General Hospital
• Investigators: Principal Investigator: Per Hall, MD PhD, Karolinska Institutet

Publications and helpful links

Helpful Links

• Research group web page

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: October 1, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Contrast Enhanced Mammography
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: KARMA Kontrast

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No