Evaluating Contrast Enhanced Mammography for Early Breast Cancer Detection
KARMA Kontrast - a Controlled Clinical Trial Evaluating Contrast Enhanced Mammography in Early Detection of Breast Cancer
This study is testing a new type of breast imaging called Contrast Enhanced Mammography to see if it can help women who have been called back for suspected breast cancer get better and more accurate results compared to standard methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 420 (estimated) |
| Ages | 25 Years to 85 Years |
| Sex | Female |
| Sponsor | Karolinska Institutet Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT04579107 on ClinicalTrials.gov |
What this trial studies
This study invites women who are part of the National Mammography Screening Program and have been recalled due to suspected breast cancer to participate in an evaluation of Contrast Enhanced Mammography. The study will compare the findings from this advanced imaging technique with standard care procedures, using two blinded radiologists to assess the results independently. Additionally, the study will evaluate potential side effects and the overall patient experience with the new imaging method.
Who should consider this trial
Good fit: Ideal candidates are women aged 25 to 85 who have been recalled for further investigation after abnormal mammographic findings.
Not a fit: Patients with a history of breast cancer, recent breast biopsies, or certain medical conditions such as renal failure or iodine contrast allergies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve early detection rates of breast cancer, leading to better patient outcomes.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for breast cancer detection, suggesting that this approach may yield beneficial results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Stockholm
- Bröstcentrum, Södersjukhuset — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Per Hall, MD PhD — Karolinska Institutet
- Study coordinator: Magnus Bäcklund, MD PhD
- Email: magnus.backlund@ki.se
- Phone: +46704663164
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.