KARMA Kontrast - a Controlled Trial Evaluating Contrast Enhanced Mammography in Early Detection of Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Contrast Enhanced Mammography
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring Contrast Enhanced Mammography
Eligibility Criteria
Inclusion Criteria:
- Female
- Age: >40 - <64 years
- Recalled after Mx screening based on abnormal mammographic findings
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Contrast Enhanced Mammography
Arm Description
All included women go through a Contrast Enhanced Mammography added to the standard of care examinations.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Tumor size assessment
Comparing Contrast Enhanced Mammography with each standard breast radiology work-up method for tumor size assessment.
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.
Contrast Enhanced Mammography costs
Calculate the costs for using Contrast Enhanced Mammography
Full Information
NCT ID
NCT04579107
First Posted
October 1, 2020
Last Updated
October 9, 2020
Sponsor
Karolinska Institutet
Collaborators
Stockholm South General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04579107
Brief Title
KARMA Kontrast - a Controlled Trial Evaluating Contrast Enhanced Mammography in Early Detection of Breast Cancer
Official Title
KARMA Kontrast - a Controlled Trial Evaluating Contrast Enhanced Mammography in Early Detection of Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 9, 2020 (Anticipated)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Stockholm South General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Contrast Enhanced Mammography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
The added Contrast Enhanced Mammography will be evaluated by a radiologist blinded from the radiologists evaluating the standard of care examinations.
Allocation
N/A
Enrollment
420 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Contrast Enhanced Mammography
Arm Type
Other
Arm Description
All included women go through a Contrast Enhanced Mammography added to the standard of care examinations.
Intervention Type
Combination Product
Intervention Name(s)
Contrast Enhanced Mammography
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity of Contrast Enhanced Mammography
Description
Evaluating sensitivity of Contrast Enhanced Mammography in detecting multifocality and/or contralateral breast cancer, compared to standard breast radiology work-up methods.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Specificity of Contrast Enhanced Mammography
Description
Estimate the specificity of Contrast Enhanced Mammography in detecting absence of breast cancer, compared to standard breast radiology work-up methods.
Time Frame
1 day
Title
Safety of Contrast Enhanced Mammography
Description
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.
Time Frame
30 days
Title
Patient acceptance of Contrast Enhanced Mammography
Description
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.
Time Frame
30 days
Title
Tumor size assessment
Description
Comparing Contrast Enhanced Mammography with each standard breast radiology work-up method for tumor size assessment.
Time Frame
1 day
Title
Mammographic density influence on the performance of Contrast Enhanced Mammography
Description
Evaluate if mammographic density influences the performance of Contrast Enhanced Mammography compared to standard breast radiology work-up methods.
Time Frame
1 day
Title
Contrast Enhanced Mammography costs
Description
Calculate the costs for using Contrast Enhanced Mammography
Time Frame
1 day
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
63 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female
Age: >40 - <64 years
Recalled after Mx screening based on abnormal mammographic findings
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magnus Bäcklund, MD PhD
Phone
+46704663164
Email
magnus.backlund@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Per Hall, MD PhD
Phone
+46852480000
Ext
+46852486152
Email
per.hall@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Hall, MD PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
https://karmastudy.org/
Description
Research group web page
Learn more about this trial
KARMA Kontrast - a Controlled Trial Evaluating Contrast Enhanced Mammography in Early Detection of Breast Cancer
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