Clinical trial · Interventional
A Study of Multiparametric MRI and pHLIP® ICG in Breast Cancer Imaging During Surgery
Phase I/IIa Study of Pre-operative Multiparametric MRI and pHLIP® ICG Intra-operative Fluorescence Imaging of Primary Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pHLIP® ICG NIRF imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRI and pHLIP® ICG
- description
- All study participants in Phase I will receive pre-operative MRI and mpMRI scans, a pre-operative injection of pHLIP ICG, and NIRF imaging during surgery (intra-operatively). During phase IIa of the study, if pHLIP® ICG NIRF imaging indicates tumor in areas outside of the planned resection area, biopsy samples will be taken from these areas and submitted for pathological analysis.
- interventionNames
- Diagnostic Test: pHLIP® ICG NIRF imaging
Primary outcomes (3)
- measure
- Dose-limiting toxicity (DLT)
- timeFrame
- 15 days post pHLIP® ICG injection
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or greater * Biopsy proven primary breast malignancy (BI-RADS 6) * Tumor stage Tis, T1 and T2, lesion size \> 1 cm * Primary surgical treatment with breast conservation * No previous treatment * ECOG performance of 0-2 Exclusion Criteria: * Life expectancy \< 3 months * Pregnancy or lactation * Known metastatic liver disease, hepatic neoplasms (benign and malignant), biliary atresia, chronic liver disease (CLD) and cirrhosis. * Known moderate hepatic impairment (in phase I, and in phase IIa dependent on safety profile established in phase I) * Known hypersensitivity to indocyanine green. * Individuals with impaired-decision making capacity
References
Publications (0)
Data not yet available