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NCT05130801 · ClinicalTrials.gov registry record · Phase 1
A Study of Multiparametric MRI and pHLIP® ICG in Breast Cancer Imaging During Surgery
A Phase 1 study of Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 2
- Study locations
NCT05130801: Recruiting Phase 1 study of Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT05130801 is a Phase 1 study of Breast Cancer that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 55 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05130801, a Phase 1 study of Breast Cancer, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST pHLIP® ICG NIRF imaging
Study Locations (2)
New Jersey
- Memorial Sloan Kettering Bergen (All Protocol Activities) - Montvale
New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2021-11-19 |
| Est. Completion | 2027-11 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05130801
The ClinicalTrials.gov registry entry for NCT05130801 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which pHLIP® ICG NIRF imaging is the first listed.
NCT05130801 reports 2 study locations spanning 2 distinct geographic areas - top geographies include New Jersey, New York.
Frequently Asked Questions
What is clinical trial NCT05130801 about?
NCT05130801 is a clinical study titled "A Study of Multiparametric MRI and pHLIP® ICG in Breast Cancer Imaging During Surgery". 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 ...
What is the current status of trial NCT05130801?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2021-11-19. Estimated completion is 2027-11.
What conditions does trial NCT05130801 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT05130801?
The interventions under investigation include: pHLIP® ICG NIRF imaging (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05130801?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05130801 being conducted?
This trial has 2 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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