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NCT06220214 · ClinicalTrials.gov registry record · Early Phase 1
Neoadjuvant Therapy and Contrast-enhanced Mammography for Early Stage Breast Cancer
A Early Phase 1 study of Breast Cancer and Triple Negative Breast Cancer, sponsored by Alison Stopeck.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06220214: Recruiting Early Phase 1 study of Breast Cancer and Triple Negative Breast Cancer, sponsored by Alison Stopeck.
NCT06220214 is a Early Phase 1 study of Breast Cancer and Triple Negative Breast Cancer that is actively recruiting participants, run by Alison Stopeck. The registered enrollment target is 30 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06220214, a Early Phase 1 study of Breast Cancer and Triple Negative Breast Cancer, is actively recruiting participants, sponsored by Alison Stopeck.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The ability of CEDM + CEDBT to predict pathologic complete response to neoadjuvant chemotherapy, determined by histopathology evaluation of the resected breast
Conditions Studied
Interventions
- DIAGNOSTIC_TEST CEDM
- DIAGNOSTIC_TEST CEDBT
- DRUG Omnipaque 350mgI/mL Solution for Injection
Study Locations (1)
New York
- Stony Brook Breast Center - Stony Brook
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-03-06 |
| Est. Completion | 2026-08-31 |
| Phase | Early Phase 1 |
What NCT06220214 shows while recruiting
NCT06220214 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 6 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which CEDM is the first listed.
NCT06220214 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06220214 about?
NCT06220214 is a clinical study titled "Neoadjuvant Therapy and Contrast-enhanced Mammography for Early Stage Breast Cancer". 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 ...
What is the current status of trial NCT06220214?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2024-03-06. Estimated completion is 2026-08-31.
What conditions does trial NCT06220214 study?
This clinical trial studies the following conditions: Breast Cancer, Triple Negative Breast Cancer, HER2-positive Breast Cancer, TNBC - Triple-Negative Breast Cancer, Locally Advanced Breast Cancer.
What interventions are being tested in trial NCT06220214?
The interventions under investigation include: CEDM (DIAGNOSTIC_TEST), CEDBT (DIAGNOSTIC_TEST), Omnipaque 350mgI/mL Solution for Injection (DRUG).
Who is sponsoring clinical trial NCT06220214?
This trial is sponsored by Alison Stopeck, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06220214 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06220214's enrollment target sits among peer trials
30 955th of 1224 higher than 227 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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