Using contrast enhanced spectral mammography to evaluate nipple discharge
Contrast Enhanced Spectral Mammography (CESM) for the Evaluation of Pathologic Nipple Discharge: A Pilot Study
This study is testing if a special type of mammogram using contrast dye can better find the causes of nipple discharge and detect breast cancer compared to regular mammograms and other imaging methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 25 Years to 85 Years |
| Sex | Female |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05056844 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of contrast enhanced spectral mammography (CESM) in evaluating pathologic nipple discharge. CESM involves an intravenous injection of iodine-based contrast to improve the visibility of tissues and blood vessels during mammography. The study aims to determine if CESM is more effective than standard mammography in identifying the underlying causes of nipple discharge and detecting breast cancer. It will compare CESM's performance against digital breast tomosynthesis and ultrasound in terms of sensitivity and specificity for detecting malignancies.
Who should consider this trial
Good fit: Ideal candidates are women aged 25-85 presenting with pathologic nipple discharge.
Not a fit: Patients with a history of allergic reactions to iodinated contrast or those with renal insufficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection of breast cancers and reduce unnecessary biopsies for patients with nipple discharge.
How similar studies have performed: Other studies have shown promise with similar imaging techniques, but the specific application of CESM for this condition is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women presenting to MDACC for the evaluation of PND as the main or accompanying symptom * Age 25-85 years * Willing to participate in the study and undergo an IV placement, able to undergo iodinated contrast injection, and able to provide informed consent Exclusion Criteria: * Reported history of an allergic reaction to iodinated contrast * History of anaphylactic reaction to any substance in the absence of a prior history of uneventful administration of iodine-based IV contrast. * Renal insufficiency * Pregnancy or lactation within 6 months * Breast surgery affecting the symptomatic breast within prior 6 months, if it was located within 5 cm from the nipple * Breast biopsy of the symptomatic breast within the last 2 months, if it was located within 5 cm from the nipple * Breast MRI performed within 24 months before the patient presented with qualifying symptoms (MRI performed contemporarily with CEM for the evaluation of new symptoms is not an exclusion criterion). * Known breast cancer or active inflammatory process (such as abscess or mastitis) in the breast of concern
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Olena Weaver, MD — M.D. Anderson Cancer Center
- Study coordinator: Olena Weaver, MD
- Email: ooweaver@mdanderson.org
- Phone: 713-471-3613
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.