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MRI + Fluorescent Imaging for Breast Cancer

Phase 1 & 2

Recruiting

Led By Katja Pinker-Domenig, MD, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Tumor stage Tis, T1 and T2, lesion size > 1 cm

ECOG performance of 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Study Summary

This trial is testing whether adding extra MRI sequences before surgery can improve outcomes by providing more accurate information about the tumor. It is also testing whether using a fluorescent imaging agent during surgery is a safe and effective way to help surgeons see and remove all of the cancer cells.

Who is the study for?

This trial is for adults over 18 with a confirmed primary breast cancer diagnosis, who haven't had previous treatments and are planning to have surgery to conserve the breast. The tumor must be stage Tis, T1 or T2 and larger than 1 cm. Participants need to be able to undergo MRI scans without any contraindications.Check my eligibility

What is being tested?

The study tests if pre-operative multiparametric MRI (mpMRI) can improve surgical outcomes by better defining the tumor's extent and acidity compared to standard MRI. It also examines whether pHLIP ICG fluorescent imaging agent used during surgery helps surgeons remove cancer more effectively.See study design

What are the potential side effects?

Since this is the first time pHLIP ICG is being tested in humans, potential side effects aren't fully known but may include reactions related to contrast agents such as allergic responses or issues due to fluorescence during surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor is in an early stage and larger than 1 cm.

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I can take care of myself and perform daily activities.

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I have not received any previous treatments.

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My breast cancer diagnosis is confirmed by a biopsy.

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I am 18 years old or older.

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I had surgery to remove cancer but kept most of my breast.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose-limiting toxicity (DLT)

Visualization of a lesion with pHLIP® ICG (Phase II)

Trial Design

1Treatment groups

Experimental Treatment

Group I: MRI and pHLIP® ICGExperimental Treatment1 Intervention

All study participants in Phase I will receive pre-operative MRI and mpMRI scans, a pre-operative injection of pHLIP ICG, and NIRF imaging during surgery (intra-operatively). 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.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

pHLIP Inc.UNKNOWN

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,934 Previous Clinical Trials

588,755 Total Patients Enrolled

202 Trials studying Breast Cancer

81,082 Patients Enrolled for Breast Cancer

Stryker InstrumentsIndustry Sponsor

14 Previous Clinical Trials

1,339 Total Patients Enrolled

Media Library

pHLIP® ICG NIRF imaging Clinical Trial Eligibility Overview. Trial Name: NCT05130801 — Phase 1 & 2

Breast Cancer Research Study Groups: MRI and pHLIP® ICG

Breast Cancer Clinical Trial 2023: pHLIP® ICG NIRF imaging Highlights & Side Effects. Trial Name: NCT05130801 — Phase 1 & 2

pHLIP® ICG NIRF imaging 2023 Treatment Timeline for Medical Study. Trial Name: NCT05130801 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many patients have been recruited for this trial thus far?

"Correct. Clinicaltrials.gov reveals that this clinical trial, first published on November 19th 2021, is actively seeking participants. 43 individuals are needed for the study from 2 different medical sites."

Answered by AI

Are there vacancies for participants in this study?

"Clinicaltrials.gov states that this medical research has begun actively seeking participants. The trial was initially uploaded on November 19th 2021 and recently saw an update to its information on the 28th of November 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Multiparametric MRI and pHLIP® ICG in Breast Cancer Imaging During Surgery

2021. "A Study of Multiparametric MRI and pHLIP® ICG in Breast Cancer Imaging During Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05130801.