Breast CancerPhase 1/2NCT02652923
Contrast Ultrasound Detection of Sentinel Lymph Nodes
A Phase 1/2 study testing Sonazoid; Perflubutane for Injection in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Sonazoid; Perflubutane for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 12 Jan 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part 1:
- Be female.
- Be at least 21 years of age.
- Must have a body mass index (BMI) greater or equal to 19 and less than or equal to 33.
- Be able to comprehend the full nature, purpose and risks of the study.
- Part 2:
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- Be female.
- Be diagnosed with breast cancer.
- Be scheduled for a surgical excision with SLN evaluation.
- Be at least 21 years of age.
- Be medically stable.
- If of child-bearing potential, must have a negative pregnancy test.
- Be able to comply with study procedures.
- Have read and signed the IRB-approved Informed Consent form for participating in the study.
Who cannot join
- Part 1:
- A history of chest wall trauma or surgery, or dermatologic disorders, which could be expected to disrupt lymphatic drainage of the chest wall.
- A history of surgical breast augmentation, reduction, or biopsy.
- Lymphedema or chronic edema.
- Females who are pregnant or nursing or are actively lactating.
- Exposure to ultrasound contrast agents in the 1 month prior to study initiation.
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- Known hypersensitivity to ultrasound contrast agents.
- Patients with a history of anaphylactic allergy to eggs or egg products, manifested by one or more of the following symptoms: generalized urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock.
- Significant axillary, supraclavicular, or other chest wall palpable adenopathy.
- Evidence of current ongoing illicit drug use or average alcohol use of greater than 2 drinks a day.
- Use of more than 5 cigarettes/day.
- Participation in an investigational drug study within the period starting 1 month before study drug administration.
- Subject is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder within the last 5 years. Subjects who have had situational depression may be enrolled in the study at the discretion of the Investigator.
- Subject has a history of any illness that, in the opinion of the study Investigator, might confound the results of the study or poses an additional risk to the subject by his participation in the study.
- An estimated creatinine clearance of ≤80 ml/min based on the Cockcroft-Gault equation. An actual creatinine clearance, as determined by a 24 hour urine collection, may be used in place of the Cockcroft-Gault equation. Subjects who have an actual or estimated creatinine clearance 70 ml/min may be enrolled at the discretion of the investigator.
- A history of neoplastic disease, with the exception of non-melanoma skin cancer.
- Any other condition precluding subject participation as per investigator judgment.
- Part 2:
- Females who are pregnant or nursing.
- Patients who have had prior breast reduction.
- Patients with a prior axillary procedure on the side scheduled for SLN evaluation.
- Patients with other primary cancers requiring systemic treatment.
- Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
- Patients on life support or in a critical care unit.
- Patients with unstable occlusive disease (e.g., crescendo angina)
- Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia.
- Patients with uncontrolled congestive heart failure (NYHA Class IV)
- Patients with recent cerebral hemorrhage.
- Patients who have undergone surgery within 24 hours prior to the study sonographic examination.
- Patients with a history of anaphylactic allergy to eggs or egg products, manifested by one or more of the following symptoms: generalized urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock. (Subjects with nonanaphylactic allergies to eggs or egg products may be enrolled in the study, but must be watched carefully for 1 h following the administration of Sonazoid).
- Patients with cardiac shunts or unstable cardiopulmonary conditions.
- Patients with congenital heart defects.
- Patients with severe emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli.
- Patients who have received any contrast medium (X-ray, MRI, CT or US) in the 24 hours prior to the research US exam
- Patients with respiratory distress syndrome.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Contrast Ultrasound Detection of Sentinel Lymph Nodes in Breast Cancer Patients
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.
Read the detailed description
This is a two part, open-label, non-randomized trial that will be conducted at Thomas Jefferson University (TJU). Initially in Part 1, a two-period, crossover, dose-finding study 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. Each volunteer will receive an injection of a low or a high dose in a blinded, sequence-randomized allocation schedule. Screening and baseline assessments/procedures will be obtained. Each volunteer will receive their subdermal, low or high dose of Sonazoid divided into four individual aliquots at four locations (12, 3, 6, and 9 o'clock) around a 2 cm in diameter region in the mid-upper outer quadrant of the left breast.
Contrast enhanced ultrasound imaging (CEUS) will be performed immediately after Sonazoid administration (i.e., lymphosonography) to identify the number, location and course of the lymphatic channels (LCs) and SLNs using a S3000 scanner (Siemens Medical Solutions, Mountain View, CA) with a high frequency, broad bandwidth linear array. CEUS evaluations will be repeated at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours and 24 hours post Sonazoid administration. The safety and tolerability of Sonazoid will be closely monitored throughout this safety and tolerability, dose-finding study.
Following at least a one week of washout, the upper outer quadrant of the right breast will be injected with the alternate dose of Sonazoid and lymphosonography will again be used to identify the number, location and course of the LCs and SLNs. Volunteers who received the low dose during their first visit will receive the high dose the next time around and vice versa in a 1:1 ratio. All procedures from the initial visit will be repeated (see above), except that the left breast (injected initially) will be assessed sonographically for the presence of contrast-enhanced tissues (injection site as well as lymphatic structures) prior to contrast administration in the right breast.
In Part 2 lymphosonography will compare SLN identification to that of isotope mapping during surgery on 90 female, breast cancer patients. A state-of-the-art S3000 scanner with contrast-specific imaging capabilities will be used to localize lymphatic drainage from breast cancers after subdermal administration of Sonazoid. The number and locations of the SLNs identified by the two imaging modalities (CEUS and isotope mapping) will be compared with dye-guided surgery as the reference standard for SLN detection. Moreover, as each SLN is resected it will be assessed ex vivo for the presence of radioactivity (using a gamma probe), Sonazoid (using CEUS) and blue dye (via visual inspection by the surgeon). All SLNs that are surgically removed will be documented and sent for histopathologic evaluation.
Trial Population: Part 1 will consist of 12 healthy, adult female volunteers in the initial safety, tolerability and dosing study.
In Part 2, 90 adult women, who have breast cancer and are scheduled for a surgical excision and SLN evaluation, will be enrolled in a clinical trial at TJU.
Statistical Methodology: Our statistical analysis will address four major questions:
- Is subdermal administration of Sonazoid in humans safe and tolerable?
- Can an optimal and efficacious dose of Sonazoid for lymphosonography be established?
- Does lymphosonography identify more SLNs in patients with breast cancer than isotope mapping (with Tc-99m sulfur colloids)?
- Does lymphosonography identify more SLNs with metastatic deposits in patients with breast cancer compared to isotope mapping?
- Conditions
- Breast Cancer
- Being tested
- Sonazoid; Perflubutane for Injection
- Keywords
- ultrasound contrast agent, lymphosonography, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonazoid; Perflubutane for InjectionDrug
Also called ultrasound microbubble contrast agent
subdermal injection into the breast of Sonazoid (1 or 2 ml) divided into four individual aliquots at four locations (12, 3, 6, and 9 o'clock)
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - volunteers | Experimental | Subdermal low (1.0 ml) or high (2.0 ml) dose injection of the ultrasound contrast agent Sonazoid divided into four individual aliquots at four locations (12, 3, 6, and 9 o'clock) around a 2 cm in diameter region in the mid-upper outer quadrant of the left breast, followed a week later by the other dose injected in the same fashion into the right breast. Receives: Drug: Sonazoid; Perflubutane for Injection |
| Part 2 - patients | Experimental | Subdermal injection of the ultrasound contrast agent of Sonazoid divided into four individual aliquots at four locations (12, 3, 6, and 9 o'clock) around the breast cancer. Subjects will receive an injection of either a low (1.0 ml) or a high (2.0 ml) dose of Sonazoid depending on the outcome of the Part 1 safety and tolerability study. Receives: Drug: Sonazoid; Perflubutane for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose optimization (1.0 vs 2.0 ml) based on the degree and duration of Sonazoid contrast-enhancement of the visualized LCs and SLNs
To establish, in healthy, female volunteers, the optimal dose of subdermaly administrated Sonazoid (an ultrasound contrast agent) employed for contrast enhanced ultrasound imaging (CEUS)
Measured: Up to 4 months
Number of subdermal Sonazoid volunteers with AEs, clinical assessments, and safety laboratory tests outside normal ranges (established by historical controls)
To assess the safety and tolerability of subdermal administration of Sonazoid in 12 female, healthy volunteers.
Measured: Up to 4 months
Number SLNs in patients with breast cancer identified by lymphosonography and by isotope mapping with Tc-99m sulfur colloids.
To determine if CEUS of subdermally administrated Sonazoid (i.e., lymphosonography) identify more sentinel lymph nodes (SLNs) in patients with breast cancer compared to isotope mapping (with Tc-99m sulfur colloids) using blue dye and surgical dissection as the reference standard. The fundamental hypothesis is that on average lymphosonography will detect 3.2 SLNs compared to 2.7 with isotope mapping.
Measured: Up to 34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study start1 Jan 2016
- Primary completion12 Jan 2022
- Study completion12 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), GE Healthcare, Siemens Medical Solutions
- Responsible party
- Sponsor
- Investigators
- Flemming Forsberg, PhD, Principal investigator, Radiology; Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652923
- Sponsor's protocol ID
- 15P.487
- Other IDs
- R01CA172336
- Status last verified
- Jan 2023
- First submitted
- 4 Jan 2016
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified data will be made available to the research community upon request after the completion of the study in accordance with NIH rules and regulations.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Ultrasound Detection of Sentinel Lymph Nodes in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02652923
- Acronym / sponsor ID
- 15P.487
- Conditions
- Breast Cancer
- Keywords
- ultrasound contrast agent, lymphosonography, breast cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), GE Healthcare, Siemens Medical Solutions
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 12 Jan 2022 (actual)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a two part, open-label, non-randomized trial that will be conducted at Thomas Jefferson University (TJU). Initially in Part 1, a two-period, crossover, dose-finding study 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. Each volunteer will receive an injection of a low or a high dose in a blinded, sequence-randomized allocation schedule. Screening and baseline assessments/procedures will be obtained. Each volunteer will receive their subdermal, low or high dose of Sonazoid divided into four individual aliquots at four locations (12, 3, 6, and 9 o'clock) around a 2 cm in diameter region in the mid-upper outer quadrant of the left breast.
Contrast enhanced ultrasound imaging (CEUS) will be performed immediately after Sonazoid administration (i.e., lymphosonography) to identify the number, location and course of the lymphatic channels (LCs) and SLNs using a S3000 scanner (Siemens Medical Solutions, Mountain View, CA) with a high frequency, broad bandwidth linear array. CEUS evaluations will be repeated at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours and 24 hours post Sonazoid administration. The safety and tolerability of Sonazoid will be closely monitored throughout this safety and tolerability, dose-finding study.
Following at least a one week of washout, the upper outer quadrant of the right breast will be injected with the alternate dose of Sonazoid and lymphosonography will again be used to identify the number, location and course of the LCs and SLNs. Volunteers who received the low dose during their first visit will receive the high dose the next time around and vice versa in a 1:1 ratio. All procedures from the initial visit will be repeated (see above), except that the left breast (injected initially) will be assessed sonographically for the presence of contrast-enhanced tissues (injection site as well as lymphatic structures) prior to contrast administration in the right breast.
In Part 2 lymphosonography will compare SLN identification to that of isotope mapping during surgery on 90 female, breast cancer patients. A state-of-the-art S3000 scanner with contrast-specific imaging capabilities will be used to localize lymphatic drainage from breast cancers after subdermal administration of Sonazoid. The number and locations of the SLNs identified by the two imaging modalities (CEUS and isotope mapping) will be compared with dye-guided surgery as the reference standard for SLN detection. Moreover, as each SLN is resected it will be assessed ex vivo for the presence of radioactivity (using a gamma probe), Sonazoid (using CEUS) and blue dye (via visual inspection by the surgeon). All SLNs that are surgically removed will be documented and sent for histopathologic evaluation.
Trial Population: Part 1 will consist of 12 healthy, adult female volunteers in the initial safety, tolerability and dosing study.
In Part 2, 90 adult women, who have breast cancer and are scheduled for a surgical excision and SLN evaluation, will be enrolled in a clinical trial at TJU.
Statistical Methodology: Our statistical analysis will address four major questions:
- Is subdermal administration of Sonazoid in humans safe and tolerable?
- Can an optimal and efficacious dose of Sonazoid for lymphosonography be established?
- Does lymphosonography identify more SLNs in patients with breast cancer than isotope mapping (with Tc-99m sulfur colloids)?
- Does lymphosonography identify more SLNs with metastatic deposits in patients with breast cancer compared to isotope mapping?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 - volunteers | Experimental | Drug: Sonazoid; Perflubutane for InjectionSubdermal low (1.0 ml) or high (2.0 ml) dose injection of the ultrasound contrast agent Sonazoid divided into four individual aliquots at four locations (12, 3, 6, and 9 o'clock) around a 2 cm in diameter region in the mid-upper outer quadrant of the left breast, followed a week later by the other dose injected in the same fashion into the right breast. |
| Part 2 - patients | Experimental | Drug: Sonazoid; Perflubutane for InjectionSubdermal injection of the ultrasound contrast agent of Sonazoid divided into four individual aliquots at four locations (12, 3, 6, and 9 o'clock) around the breast cancer. Subjects will receive an injection of either a low (1.0 ml) or a high (2.0 ml) dose of Sonazoid depending on the outcome of the Part 1 safety and tolerability study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Part 1:
- Part 2:
Key exclusion criteria (35 listed)
- Part 1:
- Part 2:
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 |
|---|---|---|
| Sonazoid; Perflubutane for InjectionAlso: ultrasound microbubble contrast agentsubdermal injection into the breast of Sonazoid (1 or 2 ml) divided into four individual aliquots at four locations (12, 3, 6, and 9 o'clock) | Drug | Part 1 - volunteers, Part 2 - patients |
Primary outcome
Dose optimization (1.0 vs 2.0 ml) based on the degree and duration of Sonazoid contrast-enhancement of the visualized LCs and SLNs
Time frame: Up to 4 months
To establish, in healthy, female volunteers, the optimal dose of subdermaly administrated Sonazoid (an ultrasound contrast agent) employed for contrast enhanced ultrasound imaging (CEUS)
Number of subdermal Sonazoid volunteers with AEs, clinical assessments, and safety laboratory tests outside normal ranges (established by historical controls)
Time frame: Up to 4 months
To assess the safety and tolerability of subdermal administration of Sonazoid in 12 female, healthy volunteers.
Number SLNs in patients with breast cancer identified by lymphosonography and by isotope mapping with Tc-99m sulfur colloids.
Time frame: Up to 34 months
To determine if CEUS of subdermally administrated Sonazoid (i.e., lymphosonography) identify more sentinel lymph nodes (SLNs) in patients with breast cancer compared to isotope mapping (with Tc-99m sulfur colloids) using blue dye and surgical dissection as the reference standard. The fundamental hypothesis is that on average lymphosonography will detect 3.2 SLNs compared to 2.7 with isotope mapping.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Individual participant dataSharing planned: Yes. De-identified data will be made available to the research community upon request after the completion of the study in accordance with NIH rules and regulations.
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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.
Flemming Forsberg, PhD principal investigator
Radiology; Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sonazoid; Perflubutane for Injection in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University 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 14 inclusion and 35 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 23 Jan 2023. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dose optimization (1.0 vs 2.0 ml) based on the degree and duration of Sonazoid contrast-enhancement of the visualized LCs and SLNs (time frame: Up to 4 months). The study lists 3 primary outcomes in all. 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 23 Jan 2023.