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New treatment option for Breast Cancer
Official title A Study of Multiparametric MRI and pHLIP® ICG in Breast Cancer Imaging During Surgery
ClinicalTrials.gov ID: NCT05130801
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Montvale, New Jersey, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montvale, New Jersey, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.