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Contrast Ultrasound Detection of Sentinel Lymph Nodes

NCT02652923 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2023-01-23

No results posted yet for this study

Summary

This is a two part, open label, non-randomized trial of women with a breast cancer diagnosis scheduled for excisional surgery and sentinel lymph node (SLN) evaluation.

Part 1 is a two-period, crossover, dose-finding study, which will be performed in 12 healthy female volunteers to determine the optimal dose as well as the safety and tolerability of the tissue-specific, contrast agent Sonazoid (GE Healthcare, Oslo, Norway) for human lymphatic applications. In Part 2 lymphosonographic SLN identification will be compared to that of isotope mapping during surgery on 90 female, breast cancer patients.

Conditions

Interventions

DRUG

Sonazoid; Perflubutane for Injection

subdermal injection into the breast of Sonazoid (1 or 2 ml) divided into four individual aliquots at four locations (12, 3, 6, and 9 o'clock)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • GE Healthcare

    collaborator INDUSTRY

  • Siemens Medical Solutions

    collaborator INDUSTRY

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Flemming Forsberg, PhD · Radiology; Thomas Jefferson University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2022-01-12
Completion
2022-01-12

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02652923 on ClinicalTrials.gov