NCT05130801 A Study of Multiparametric MRI and pHLIP® ICG in Breast Cancer Imaging During Surgery
| NCT ID | NCT05130801 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2021-11-19 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 55 participants in total. It began in 2021-11-19 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Clarissa Lin, MD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT05130801 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05130801 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05130801 currently recruiting?
Yes, NCT05130801 is actively recruiting participants. Contact the research team at linc5@mskcc.org for enrollment information.
Where is the NCT05130801 trial being conducted?
This trial is being conducted at Montvale, United States, New York, United States.
Who is sponsoring the NCT05130801 clinical trial?
NCT05130801 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Clarissa Lin, MD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 55 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.