Feasibility of Ultrasound Microbubble Contrast-Enhanced (CEUS) Sentinel Lymph Node Imaging With Guided Biopsy in Breast Cancer Patients
2 other identifiers
interventional
21
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Jul 2015
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2014
CompletedFirst Posted
Study publicly available on registry
December 22, 2014
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedResults Posted
Study results publicly available
June 20, 2017
CompletedJune 20, 2017
May 1, 2017
10 months
December 17, 2014
May 24, 2017
May 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Breast Cancer Participants With Sentinel Lymph Nodes (SLN) Identification Using the CEUS Technique
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.
1 day
Study Arms (1)
Perflutren Protein-Type A Microspheres Injectable Suspension
EXPERIMENTALParticipants receive a subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension (OPTISON™). Ultrasound images and videos of tumor and lymph nodes in underarm area taken. 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. Participant called by phone 30 days after seed is removed to check for any side effects. This phone call should take about 10 minutes.
Interventions
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.
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 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.
Participant called by phone 30 days after seed is removed to check for any side effects. This phone call should take about 10 minutes.
Eligibility Criteria
You may qualify if:
- years or older.
- Ipsilateral biopsy-proven invasive breast cancer \<5 cm in maximal dimension by Ultrasound or Mammography.
- No abnormal axillary nodes identified on grayscale AUS, or abnormal nodes with benign subsequent FNA biopsy.
You may not qualify if:
- Pregnant or nursing women
- Prior SLN dissection
- Neoadjuvant chemotherapy.
- Prior axillary lymph node surgery.
- Prior history of ipsilateral breast cancer.
- Known or suspected: Cardiac shunts
- Known or suspected: hypersensitivity to perflutren, blood, blood products or albumin
- Known or suspected: hypersensitivity to a prior OPTISON administration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- GE Healthcarecollaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Basak Dogan/Diagnostic Radiology
- Organization
- The University of Texas (UT) MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Basak Dogan, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2014
First Posted
December 22, 2014
Study Start
July 1, 2015
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
June 20, 2017
Results First Posted
June 20, 2017
Record last verified: 2017-05