An official website of the United States government
Investigational Scans (Multiparametric MRI and pHLIP ICG NIRF) for Breast Cancer Imaging in Patients Undergoing Surgery
Trial Status: active
This phase I/IIa trial tests the safety, side effects, and best dose of an imaging agent called pHLIP ICG when given with near infrared fluorescent imaging (NIRF) during surgery to remove the cancer, and investigates how well a type of magnetic resonance imaging (MRI) called multiparametric MRI works in imaging breast cancer before surgery. Tumor acidity plays an important role in the development and growth (progression) of breast cancers, and acidity is a feature of all sizes, grades, and stages of breast cancer. pHLIP ICG targets the acids on the surface of cancer cells, so it is able to “mark” tumors very precisely. NIRF may detect the cancer cells "marked" by pHLIP ICG. Multiparametric MRI may help researchers determine the extent of the cancer and find out new information about the acidity of the tumor before surgery. Pre-surgical multiparametric MRI and pHLIP ICG NIRF during surgery may allow the surgeon to see the tissues that contain cancer cells more clearly and remove them completely.
Inclusion Criteria
Age 18 years or greater
Biopsy proven primary breast malignancy (Breast Imaging Reporting and Data System [BI-RADS] 6)
Tumor stage Tis, T1 and T2, lesion size > 1 cm
Primary surgical treatment with breast conservation
No previous treatment
No contraindications for MRI or MRI contrast agents or high-field MRI (3T)
Eastern Cooperative Oncology Group (ECOG) performance of 0–2
Exclusion Criteria
Life expectancy < 3 months
Pregnancy or lactation
Known contrast agent allergies that require premedication before MRI
Patients who cannot undergo multiparametric MRI scanning because of:
* Weight limits. MRI scanners may not be able to function with patients over 450 pounds
* Severe claustrophobia/ examination associated anxiety
* MRI unsafe implant
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
Additional locations may be listed on ClinicalTrials.gov for NCT05130801.
Locations matching your search criteria
United States
New Jersey
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Clarissa Lin
Phone: 646-888-5119
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Clarissa Lin
Phone: 646-888-5119
PRIMARY OBJECTIVES:
I. To determine the feasibility and safety of pH-low insertion peptide-indocyanine green (pHLIP ICG) by evaluating post-injection clinical adverse events and to select the optimal imaging dose of pHLIP ICG for intra-operative near-infrared fluorescence (NIRF) imaging for phase IIa. (Phase Ia)
II. To evaluate the concordance of the optical signal at the selected optimal dose with the histopathological confirmation (gold standard) of breast cancer (BC). (Phase IIa)
SECONDARY OBJECTIVES:
I. To optimize the multiparametric research 3 Tesla (3T) magnetic resonance imaging (MRI) sequence protocol for the non-invasive assessment of the tumor microenvironment (TME) and tissue acidity. (Phase Ia)
II. To establish pharmacokinetic (PK) for pHLIP ICG. (Phase Ia)
III. To optimize the immunohistochemistry protocol for staining of the excised specimens with the following markers: LDHA (lactate dehydrogenase A), CAIX (carbonic anhydrase IX), Ki67 (nuclear protein), MMP9 (metalloproteinases 9), CD68, and CD163 for targeting of tumor-associated macrophages (TAMs). (Phase Ia)
IV. To conduct a preliminary assessment of the accuracy of pHLIP ICG NIRF imaging for the intra-operative prediction of margin positivity. (Phase IIa)
V. To conduct a preliminary assessment of the correlations between pHLIP ICG NIRF imaging and advanced multiparametric 3T MRI assessment of lesion extent, volume, acidity, and TME structure. (Phase IIa)
VI. To continue safety assessment. (Phase IIa)
EXPLORATORY OBJECTIVE:
I. To conduct a preliminary assessment of the correlation of pHLIP ICG and markers of tumor acidity (LDHA and CAIX), tumor proliferation and growth (Ki67 and MMP9), and TAMs identified by immunohistochemistry on histological sections of the excised specimens. (Phase IIa)
OUTLINE: This is a phase I, dose-escalation study of pHLIP ICG followed by a phase II study.
Patients undergo multiparametric MRI imaging 1-6 weeks before surgery. Patients then receive pHLIP ICG intravenously (IV) over 1 minute 12-56 hours before surgery, followed by NIRF imaging during surgery. Patients undergo collection of urine samples (for phase I patients) and blood sample collection throughout the study.
After surgery, patients are followed up within 7-14 days and 30-40 days.
Trial PhasePhase I/II
Trial Typediagnostic
Lead OrganizationMemorial Sloan Kettering Cancer Center
