Trial Outcomes & Findings for Feasibility of Ultrasound Microbubble Contrast-Enhanced (CEUS) Sentinel Lymph Node Imaging With Guided Biopsy in Breast Cancer Patients (NCT NCT02321527)

Last Updated: 2017-06-20

Results Overview

Following the Microbubble CEUS of ipsilateral axillary nodes, needle biopsy and I-125 seed placement, a single node/participant (biopsied node) will be included in the statistical evaluation. The technique determined as technically feasible if an enhancing node is visualized in at least 90% of the subjects and 80% concordance is achieved between imaging-guided biopsy and final surgical histopathology. If no enhancement is identified, the overlying skin will be massaged, and re-injection of contrast will be employed up to three times. If no contrast enhancement in lymphatics is observed, the case will be reported as a failure of the CEUS technique.

Recruitment status

COMPLETED

Study phase

Target enrollment

21 participants

Primary outcome timeframe

1 day

Results posted on

2017-06-20

Participant Flow

Recruitment Period: July 09, 2015 to February 22, 2016. All recruitment done at The University of Texas MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	CEUS SNL Imaging + Guided Biopsy Subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension before Contrast-Enhanced Ultrasound (CEUS), sentinel lymph node (SNL) biopsy and radioactive seed placement.
Overall Study STARTED	21
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CEUS Sentinel Lymph Node Imaging + Guided Biopsy n=21 Participants Subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension before Contrast-Enhanced Ultrasound (CEUS), sentinel lymph node biopsy and radioactive seed placement.
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Outcome measures

Outcome measures
Measure	CEUS Sentinel Lymph Node Imaging + Guided Biopsy n=21 Participants Subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension before Contrast-Enhanced Ultrasound (CEUS), sentinel lymph node biopsy and radioactive seed placement.
Number of Breast Cancer Participants With Sentinel Lymph Nodes (SLN) Identification Using the CEUS Technique	20 Participants

Adverse Events

CEUS Sentinel Lymph Node Imaging + Guided Biopsy

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	CEUS Sentinel Lymph Node Imaging + Guided Biopsy n=21 participants at risk Subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension before Contrast-Enhanced Ultrasound (CEUS), sentinel lymph node biopsy and radioactive seed placement.
Skin and subcutaneous tissue disorders Pain of skin	9.5% 2/21 • Number of events 2 • Adverse events were collected during the course of the CEUS SLN imaging and biopsy expected to all performed in a single interaction one day.
Gastrointestinal disorders Nausea	4.8% 1/21 • Number of events 1 • Adverse events were collected during the course of the CEUS SLN imaging and biopsy expected to all performed in a single interaction one day.

Additional Information

Dr. Basak Dogan/Diagnostic Radiology

The University of Texas (UT) MD Anderson Cancer Center

Phone: 713-792-7734

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place