Improving breast cancer surgery with advanced MRI and fluorescent imaging
Phase I/IIa Study of Pre-operative Multiparametric MRI and pHLIP® ICG Intra-operative Fluorescence Imaging of Primary Breast Cancer
This study is testing a new way to use advanced MRI and a special dye to help breast cancer patients have better surgery by making tumors easier to see and remove.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 2 sites (Montvale, New Jersey and 1 other locations) |
| Trial ID | NCT05130801 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of multiparametric MRI and the fluorescent imaging agent pHLIP® ICG to enhance surgical outcomes for breast cancer patients. The study aims to provide more accurate information about tumor extent and acidity, potentially allowing for more complete tumor removal during surgery. In the first phase, patients will undergo advanced MRI scans to assess tumor characteristics, followed by the administration of pHLIP® ICG before surgery to improve visualization of cancerous tissues. This is the first study to evaluate the safety and efficacy of this combined imaging approach in humans.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with biopsy-proven primary breast cancer at stages Tis, T1, or T2, who are scheduled for breast-conserving surgery.
Not a fit: Patients with life expectancy less than three months, known metastatic liver disease, or those who cannot undergo MRI due to various contraindications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical precision and outcomes for breast cancer patients.
How similar studies have performed: This approach is novel and has not been previously tested in humans, making it a pioneering effort in breast cancer imaging.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Montvale, New Jersey and 1 other locations
- Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Clarissa Lin, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Clarissa Lin, MD
- Email: linc5@mskcc.org
- Phone: 646-888-5119
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.