Breast CancerNCT02321527
Feasibility of Ultrasound Microbubble Contrast-Enhanced (CEUS) Sentinel Lymph Node Imaging With Guided Biopsy in Breast Cancer Patients
A study testing Perflutren Protein-Type A Microspheres Injectable Suspension, Contrast-Enhanced Ultrasound (CEUS) and Biopsy + Radioactive Seed Placement in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Perflutren Protein-Type A Microspheres Injectable Suspension, Contrast-Enhanced Ultrasound (CEUS) and Biopsy + Radioactive Seed Placement
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Feasibility of Ultrasound Microbubble Contrast-Enhanced (CEUS) Ultrasound Sentinel Lymph Node Imaging With Guided Biopsy in Breast Cancer Patients
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.
Read the detailed description
Study Procedures:
If you agree and are eligible to take part, you will receive perflutren protein type A by injection under the skin near the nipple. After you receive the injection, the radiologist will take more ultrasound images and videos of the tumor and lymph nodes in the underarm area.
You will have a biopsy of the sentinel lymph node that was identified in the ultrasound and a titanium clip marker will be inserted into the node. The clip helps distinguish the biopsied node from other nodes. You will be told the results of biopsy. After the biopsy, a radioactive seed may be inserted into the node to allow the surgeon to find and remove it during your surgery, an extra node may be removed at that time.
You will still have standard of care sentinel lymph node biopsy during your already scheduled surgery. You will sign a separate surgical consent form that explains this procedure and its risks.
You will be called by phone 30 days after the seed is removed to check for any side effects. This phone call should take about 10 minutes.
Length of Study:
Your active participation in this study will be over the follow up phone call.
This is an investigational study. Perflutren protein type A is FDA approved and commercially available for use in contrast-enhanced echocardiograms. Its use in this study is investigational.
Up to 21 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Breast Cancer
- Being tested
- Perflutren Protein-Type A Microspheres Injectable Suspension, Contrast-Enhanced Ultrasound (CEUS), Biopsy + Radioactive Seed Placement, Phone Call
- Keywords
- Breast Cancer, Microbubble contrast-enhanced ultrasound, CEUS, Sentinel lymph nodes, SLN, Perflutren Protein-Type A Microspheres Injectable Suspension, OPTISON™, Ultrasound, Breast biopsy, Radioactive seed, Phone call, Fine needle aspiration, FNA
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perflutren Protein-Type A Microspheres Injectable SuspensionDrug
Also called OPTISON
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 or surgery
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 CallBehavioural
Participant called by phone 30 days after seed is removed to check for any side effects. This phone call should take about 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Perflutren Protein-Type A Microspheres Injectable Suspension | Experimental | Participants 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. Receives: Drug: Perflutren Protein-Type A Microspheres Injectable Suspension; Device: Contrast-Enhanced Ultrasound (CEUS); Procedure: Biopsy + Radioactive Seed Placement; Behavioral: Phone Call |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startJul 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Basak Dogan, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321527
- Sponsor's protocol ID
- 2014-0611
- Other IDs
- NCI-2015-00066
- Status last verified
- May 2017
- First submitted
- 17 Dec 2014
- Last updated
- 20 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Ultrasound Microbubble Contrast-Enhanced (CEUS) Ultrasound Sentinel Lymph Node Imaging With Guided Biopsy in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02321527
- Acronym / sponsor ID
- 2014-0611
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Microbubble contrast-enhanced ultrasound, CEUS, Sentinel lymph nodes, SLN, Perflutren Protein-Type A Microspheres Injectable Suspension, OPTISON™, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- Jul 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 22 Dec 2014 (estimated)
- Results
- Posted 20 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Procedures:
If you agree and are eligible to take part, you will receive perflutren protein type A by injection under the skin near the nipple. After you receive the injection, the radiologist will take more ultrasound images and videos of the tumor and lymph nodes in the underarm area.
You will have a biopsy of the sentinel lymph node that was identified in the ultrasound and a titanium clip marker will be inserted into the node. The clip helps distinguish the biopsied node from other nodes. You will be told the results of biopsy. After the biopsy, a radioactive seed may be inserted into the node to allow the surgeon to find and remove it during your surgery, an extra node may be removed at that time.
You will still have standard of care sentinel lymph node biopsy during your already scheduled surgery. You will sign a separate surgical consent form that explains this procedure and its risks.
You will be called by phone 30 days after the seed is removed to check for any side effects. This phone call should take about 10 minutes.
Length of Study:
Your active participation in this study will be over the follow up phone call.
This is an investigational study. Perflutren protein type A is FDA approved and commercially available for use in contrast-enhanced echocardiograms. Its use in this study is investigational.
Up to 21 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perflutren Protein-Type A Microspheres Injectable Suspension | Experimental | Drug: Perflutren Protein-Type A Microspheres Injectable Suspension, Device: Contrast-Enhanced Ultrasound (CEUS), Procedure: Biopsy + Radioactive Seed Placement, Behavioral: Phone CallParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 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.
Key exclusion criteria (8 listed)
- Pregnant or nursing women
- Prior SLN dissection
- Neoadjuvant chemotherapy.
- Prior axillary lymph node surgery.
- Prior history of ipsilateral breast cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perflutren Protein-Type A Microspheres Injectable SuspensionAlso: OPTISONParticipants 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. | Drug | Perflutren Protein-Type A Microspheres Injectable Suspension |
| Contrast-Enhanced Ultrasound (CEUS)Ultrasound images of breast and videos of tumor and lymph nodes in underarm area taken after Perflutren Protein-Type A Microspheres Injectable Suspension injection. | Device | Perflutren Protein-Type A Microspheres Injectable Suspension |
| Biopsy + Radioactive Seed PlacementBiopsy 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. | Procedure or surgery | Perflutren Protein-Type A Microspheres Injectable Suspension |
| Phone CallParticipant called by phone 30 days after seed is removed to check for any side effects. This phone call should take about 10 minutes. | Behavioural | Perflutren Protein-Type A Microspheres Injectable Suspension |
Primary outcome
Number of Breast Cancer Participants With Sentinel Lymph Nodes (SLN) Identification Using the CEUS Technique
Time frame: 1 day
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Basak Dogan, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perflutren Protein-Type A Microspheres Injectable Suspension, Contrast-Enhanced Ultrasound (CEUS) and Biopsy + Radioactive Seed Placement in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Breast Cancer Participants With Sentinel Lymph Nodes (SLN) Identification Using the CEUS Technique (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017.