CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
Perflutren Protein-Type A Microspheres Injectable Suspension +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02321527
NCT02321527N/ACompleted

Feasibility of Ultrasound Microbubble Contrast-Enhanced (CEUS) Ultrasound Sentinel Lymph Node Imaging With Guided Biopsy in Breast Cancer Patients

M.D. Anderson Cancer Center·interventional·Posted Dec 22, 2014·Updated Jun 20, 2017

In Brief

A clinical study evaluating Perflutren Protein-Type A Microspheres Injectable Suspension, Contrast-Enhanced Ultrasound (CEUS), and 2 other interventions for Breast Cancer. Completed, enrolled 21 participants across 1 site.

Detailed Summary

The goal of this clinical research is to learn if an ultrasound contrast agent called OPTISON (perflutren protein type A) is effective in finding sentinel lymph nodes before surgery. Contrast agents can help make ultrasound images more accurate. The sentinel lymph node is the first node that may be the target of cancer cells that spread from the tumor.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsGE Healthcare

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 22, 2014
Enrollment StartJul 1, 2015
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 11.5 years ago

Interventions

Perflutren Protein-Type A Microspheres Injectable Suspensiondrug

Participants receive a subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension (OPTISON™) before breast ultrasound.

Contrast-Enhanced Ultrasound (CEUS)device

Ultrasound images of breast and videos of tumor and lymph nodes in underarm area taken after Perflutren Protein-Type A Microspheres Injectable Suspension injection.

Biopsy + Radioactive Seed Placementprocedure

Biopsy of sentinel lymph node that was identified in ultrasound performed, and a titanium clip marker inserted into the node. After biopsy, a radioactive seed may be inserted into the node to allow surgeon to find and remove it during surgery.

Phone Callbehavioral

Participant called by phone 30 days after seed is removed to check for any side effects. This phone call should take about 10 minutes.