RightFit
RecruitingPhase 1 / Phase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults with breast cancer who will have surgery that keeps the breast. It tests whether extra MRI scans before surgery can better show the cancer’s size, spread, and acidity. It also tests whether pHLIP ICG, a dye being tested in people for the first time, is safe and helps surgeons see and fully remove cancer using special light imaging.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Breast cancer confirmed by a biopsy, a test of a tissue sample.
  • Tumor stage Tis, T1, or T2, with a tumor larger than 1 cm.
  • Plan to have surgery that removes the cancer but keeps the breast.
  • No previous treatment.
  • Able to care for yourself and be up and about for at least half the day (ECOG score 0–2).

Who can't join

  • Expected to live less than 3 months.
  • Pregnant or breastfeeding.
  • Known cancer that has spread to the liver, or any liver tumor, even one that is not cancer.
  • Known long-term liver disease, liver scarring, or blocked or missing bile ducts (biliary atresia).
  • Known moderately reduced liver function in Phase I; this may also rule you out in Phase IIa, based on Phase I safety results.
  • Known allergy to indocyanine green, the dye called ICG.
  • Reduced ability to make decisions.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (2)

NJ

NY