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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.
Primary Outcome
is defined as a clinically significant adverse event recorded within 3 hours after pHLIP® ICG administration or an abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, surgery, or concomitant medications, and meets the NCI common terminology criteria that are CTCAE Grade 3 or 4.
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 |
What NCT05130801 shows while recruiting
NCT05130801 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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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 NCT05130801's enrollment target sits among peer trials
55 767th of 1224 higher than 452 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.
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