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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04579107
Recruitment Status : Not yet recruiting
First Posted : October 8, 2020
Last Update Posted : October 14, 2020
Sponsor:
Collaborator:
Stockholm South General Hospital
Information provided by (Responsible Party):
Per Hall, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Combination Product: Contrast Enhanced Mammography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: N/A
Intervention 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.
Primary Purpose: Diagnostic
Official Title: KARMA Kontrast - a Controlled Trial Evaluating Contrast Enhanced Mammography in Early Detection of Breast Cancer
Estimated Study Start Date : November 9, 2020
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Sensitivity of Contrast Enhanced Mammography [ Time Frame: 1 day ]
    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 :
  1. Specificity of Contrast Enhanced Mammography [ Time Frame: 1 day ]
    Estimate the specificity of Contrast Enhanced Mammography in detecting absence of breast cancer, compared to standard breast radiology work-up methods.

  2. Safety of Contrast Enhanced Mammography [ Time Frame: 30 days ]
    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.

  3. Patient acceptance of Contrast Enhanced Mammography [ Time Frame: 30 days ]
    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.

  4. Tumor size assessment [ Time Frame: 1 day ]
    Comparing Contrast Enhanced Mammography with each standard breast radiology work-up method for tumor size assessment.

  5. Mammographic density influence on the performance of Contrast Enhanced Mammography [ Time Frame: 1 day ]
    Evaluate if mammographic density influences the performance of Contrast Enhanced Mammography compared to standard breast radiology work-up methods.

  6. Contrast Enhanced Mammography costs [ Time Frame: 1 day ]
    Calculate the costs for using Contrast Enhanced Mammography



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 63 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04579107


Contacts
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Contact: Magnus Bäcklund, MD PhD +46704663164 magnus.backlund@ki.se
Contact: Per Hall, MD PhD +46852480000 ext +46852486152 per.hall@ki.se

Sponsors and Collaborators
Karolinska Institutet
Stockholm South General Hospital
Investigators
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Principal Investigator: Per Hall, MD PhD Karolinska Institutet
Additional Information:
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Responsible Party: Per Hall, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04579107    
Other Study ID Numbers: KARMA Kontrast
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Per Hall, Karolinska Institutet:
Contrast Enhanced Mammography
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases