NCT06220214 Neoadjuvant Therapy and Contrast-enhanced Mammography for Early Stage Breast Cancer
| NCT ID | NCT06220214 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Alison Stopeck |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-03-06 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2024-03-06 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to compare a special type of mammogram that uses a contrast agent called contrast-enhanced digital mammography with contrast-enhanced digital breast tomosynthesis (CEDM+CEDBT), with breast magnetic resonance imaging imaging (MRI) for predicting the effect of neoadjuvant chemotherapy on pathologic complete response rates. The device used to obtain CEDM+CEDBT images is called Siemens MAMMOMAT. This device produces two-dimensional (2D) images, as in a normal mammogram, but also collects additional images for digital breast tomosynthesis (DBT), which produces a three-dimensional (3D) image of the breast in the form of image slices. DBT allows the radiologist to "see through" the breast tissue for better detection and localization of breast cancer. By looking at both the CEDM images and the CEDBT images, a radiologist may be able to better detect residual breast cancer in a more cost-effective manner. Participation may last up to 18 weeks. Study procedures for this research are: * Undergoing 1-2 mammograms during and/or after your chemotherapy, but before primary breast surgery. * Before each mammogram, have a radiology technician inject a liquid contrast agent by inserting a needle into a vein. The chemotherapy port cannot be used to receive the contrast agent * Let the research team record information from your medical record related to your condition and the treatment you receive. * Give permission to collect leftover tissue from your diagnostic biopsy and breast surgery.
Eligibility Criteria
Inclusion Criteria: * Diagnosis with either type of invasive locally advanced breast cancer regardless of hormone receptor or Her2 status * Plan to receive at least 4 cycles of neoadjuvant chemotherapy ahead of definitive surgery Exclusion Criteria: * Pregnancy * Allergy/sensitivity to contrast agent * Decreased kidney function * Diabetes
Contact & Investigator
Alison Stopeck, MD
PRINCIPAL INVESTIGATOR
Stony Brook Cancer Center
Frequently Asked Questions
Who can join the NCT06220214 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06220214 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06220214 currently recruiting?
Yes, NCT06220214 is actively recruiting participants. Contact the research team at alison.stopeck@stonybrookmedicine.edu for enrollment information.
Where is the NCT06220214 trial being conducted?
This trial is being conducted at Stony Brook, United States.
Who is sponsoring the NCT06220214 clinical trial?
NCT06220214 is sponsored by Alison Stopeck. The principal investigator is Alison Stopeck, MD at Stony Brook Cancer Center. The trial plans to enroll 30 participants.
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