RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase I/IIa Study of Pre-operative Multiparametric MRI and pHLIP® ICG Intra-operative Fluorescence Imaging of Primary Breast Cancer

Quick Facts

Study Start:2021-11-19
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05130801

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or greater
  2. * Biopsy proven primary breast malignancy (BI-RADS 6)
  3. * Tumor stage Tis, T1 and T2, lesion size \> 1 cm
  4. * Primary surgical treatment with breast conservation
  5. * No previous treatment
  6. * No contraindications for MRI or MRI contrast agents or high-field MRI (3T)
  7. * ECOG performance of 0-2
  1. * Life expectancy \< 3 months
  2. * Pregnancy or lactation
  3. * Known contrast agent allergies that require premedication before MRI.
  4. * Patients who cannot undergo multiparametric MRI scanning because of:
  5. * Weight limits. MRI scanners may not be able to function with patients over 450 pounds.
  6. * Severe claustrophobia/ examination associated anxiety.
  7. * MRI unsafe implant
  8. * Known metastatic liver disease, hepatic neoplasms (benign and malignant), biliary atresia, chronic liver disease (CLD) and cirrhosis.
  9. * Known moderate hepatic impairment (in phase I, and in phase IIa dependent on safety profile established in phase I)
  10. * Known hypersensitivity to indocyanine green.
  11. * Individuals with impaired-decision making capacity

Contacts and Locations

Study Contact

Clarissa Lin, MD
CONTACT
646-888-5119
linc5@mskcc.org
Monica Morrow, MD
CONTACT
646-888-5350

Principal Investigator

Clarissa Lin, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Clarissa Lin, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-19
Study Completion Date2026-11

Study Record Updates

Study Start Date2021-11-19
Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

  • MRI
  • pHLIP® ICG
  • Imaging
  • Tumor stage T1-T2
  • 21-225
  • SPY-PHI Systems

Additional Relevant MeSH Terms

  • Breast Cancer