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New treatment option for Breast Carcinoma
Official title Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge
ClinicalTrials.gov ID: NCT05056844
What this study is testing
What is Iodinated Contrast Agent?
Iodinated Contrast Agent is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast carcinoma.
Also referred to as Iodinated Contrast Dye, Iodine-containing Contrast Media.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical trial studies contrast enhanced spectral mammography (CESM) for the evaluation of pathologic nipple discharge. CESM is similar to standard mammography, but it includes an intravenous (by vein) injection of an iodine-based contrast, which makes tissue and blood vessels more visible in scans.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 85, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 25 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.