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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
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Contrast Enhanced Mammography

Eligibility Criteria

40 Years - 63 Years (Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    October 1, 2020
    Last Updated
    October 9, 2020
    Sponsor
    Karolinska Institutet
    Collaborators
    Stockholm South General Hospital
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    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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