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NCT02652923 · ClinicalTrials.gov registry record · Phase 1

Contrast Ultrasound Detection of Sentinel Lymph Nodes

A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.

Completed
Registry status
Phase 1
Development phase
98
Enrollment target

NCT02652923 is a Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 98 participants.

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The verdict

NCT02652923, a Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.

COMPLETED
Registry status
Phase 1
Development phase
98 participants
Enrollment target

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.

Interventions

  • DRUG Sonazoid; Perflubutane for Injection

Trial Details

FieldValue
Enrollment Target 98 participants
Start Date 2016-01-01
Est. Completion 2022-01-12
Phase Phase 1

What the Registry Record Tells You About NCT02652923

The ClinicalTrials.gov registry entry for NCT02652923 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Sonazoid; Perflubutane for Injection is the first listed.

NCT02652923 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02652923 about?

NCT02652923 is a clinical study titled "Contrast Ultrasound Detection of Sentinel Lymph Nodes". 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 opt...

What is the current status of trial NCT02652923?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 98 participants. The study started on 2016-01-01. Estimated completion is 2022-01-12.

What interventions are being tested in trial NCT02652923?

The interventions under investigation include: Sonazoid; Perflubutane for Injection (DRUG).

Who is sponsoring clinical trial NCT02652923?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.