A Study of Multiparametric MRI and pHLIP® ICG in Breast Cancer Imaging During Surgery
Public ClinicalTrials.gov record NCT05130801. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase I/IIa Study of Pre-operative Multiparametric MRI and pHLIP® ICG Intra-operative Fluorescence Imaging of Primary Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to find out whether pre-operative mpMRI using additional MRI sequences may improve surgical outcomes by providing more accurate information about the extent and acidity of the tumor than standard MRI, and to see whether the use of the fluorescent imaging agent pHLIP ICG and NIRF imaging during surgery is a safe approach that may allow the surgeon to see the tumor and nearby tissues that contain cancer cells more clearly and remove them completely. During the Phase IIa part of this study, the safe dose of pHLIP ICG will be used that makes it easy for the surgeon to see the tumor and the nearby tissues and structures that may contain cancer cells. This study is the first to test pHLIP ICG in people, and the first to test the use of pHLIP ICG with mpMRI and NIRF imaging in surgery for breast cancer.
Study identification
- NCT ID
- NCT05130801
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 55 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 18, 2021
- Primary completion
- Oct 31, 2027
- Completion
- Oct 31, 2027
- Last update posted
- Apr 21, 2026
2021 – 2027
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Memorial Sloan Kettering Bergen (All Protocol Activities) | Montvale | New Jersey | 07645 | Recruiting |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York | 10065 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05130801, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 21, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05130801 live on ClinicalTrials.gov.