Cutaneous MelanomaPhase 1NCT02968680
Sonazoid-Enhanced Ultrasound in Detecting Sentinel Lymph Node in Patients With Cutaneous Melanoma
A Phase 1 study testing Sentinel Lymph Node Biopsy, Ultrasonography and Sonazoid in people with Cutaneous Melanoma and Melanoma, run by University of Southern California at 1 site in United States.
Trial summary
This pilot phase I trial studies how well sonazoid-enhanced ultrasound works in detecting sentinel lymph node in patients with cutaneous melanoma. Sonazoid is a contrast agent that may make it easier to see if the tumor cells have spread to the sentinel lymph node using an ultrasound. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cutaneous Melanoma, Melanoma
- What is being tested?
- Sentinel Lymph Node Biopsy, Ultrasonography and Sonazoid
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2017to 9 Jan 2020
- Phase
- Phase 1
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cutaneous melanoma with Breslow depth > 1 mm or melanoma Breslow depth of 0.76 - 1.00 mm in setting of ulceration, extensive regression
- Mitotic rate >= 1/mm^2
- Presence of angiolymphatic invasion
- Deep positive margin
- No known allergies to contrast material
Who cannot join
- Pregnant or nursing
- Patients with known cardiac shunt
- Patients with class II heart failure or worse, per New York Heart Association (NYHA) classification
- Patients who have experienced an acute coronary syndrome or angina in the past 6 months
- Patients who have undergone coronary artery bypass grafting (CABG) or coronary stenting in the past 3 years
- Patients with evidence of moderate or severe cardiac valvular disease on echocardiogram
Show all 11Show fewer
- Patients with evidence of moderate or severe pulmonary hypertension on echocardiogram
- Patients with stage II chronic obstructive pulmonary disease (COPD) or worse, per Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification
- Patients with hypersensitivity to sonazoid or one of its components
- Patients with hypersensitivity to egg or egg products, because sonazoid contains a chicken egg-derived surfactant (hydrogenated egg phosphatidylserine sodium)
- Patients who cannot consent for themselves
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Pilot Translational Study of Sonazoid-Enhanced Ultrasonography for Sentinel Lymph Node Mapping in Cutaneous Melanoma
This pilot phase I trial studies how well sonazoid-enhanced ultrasound works in detecting sentinel lymph node in patients with cutaneous melanoma. Sonazoid is a contrast agent that may make it easier to see if the tumor cells have spread to the sentinel lymph node using an ultrasound.
Read the detailed description
PRIMARY OBJECTIVES:
- To study the imaging feasibility of peri-tumoral administration of sonazoid ultrasound contrast agent for assessment of sentinel lymph node (SLN) detection in melanoma.
II. To compare SLN detection between sonazoid ultrasound and standard of care (SOC) technique.
SECONDARY OBJECTIVES:
- To assess the sonazoid ultrasound (US) imaging appearance of lymph nodes which are shown to be involved with metastatic disease.
OUTLINE:
Patients receive sonazoid intradermally (ID) and undergo ultrasound imaging. Patients also undergo standard of care sentinel lymph node biopsy (SLNB).
After completion of study treatment, patients are followed up at 24 and 48 hours.
- Conditions
- Cutaneous Melanoma, Melanoma
- Being tested
- Sentinel Lymph Node Biopsy, Ultrasonography, Sonazoid
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel Lymph Node BiopsyProcedure or surgery
Also called Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB
Undergo SLNB
UltrasonographyDevice
Also called ULTRASOUND, Ultrasound Imaging, Ultrasound Test, Ultrasound, Medical
Undergo sonazoid-enhanced ultrasonography
SonazoidDrug
Also called Contrast ultrasound microvascular perfusion imaging
Patients receive sonazoid intradermally (ID) and undergo ultrasound imaging.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (sonazoid, ultrasound imaging, SLNB) | Experimental | Patients receive sonazoid ID and undergo ultrasound imaging. Patients also undergo standard of care SLNB. Receives: Procedure: Sentinel Lymph Node Biopsy; Device: Ultrasonography; Drug: Sonazoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients with SLN identified by sonazoid-US alone or both sonazoid-US and conventional methods
Analyzed using descriptive comparison.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study start26 Apr 2017
- Primary completion28 Jun 2019
- Study completion9 Jan 2020
Why it stopped: Insufficient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous MelanomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kevin King, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968680
- Sponsor's protocol ID
- 10M-15-3
- Other IDs
- NCI-2016-01088, 10M-15-3, P30CA014089
- Status last verified
- Mar 2020
- First submitted
- 2 Aug 2016
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Translational Study of Sonazoid-Enhanced Ultrasonography for Sentinel Lymph Node Mapping in Cutaneous Melanoma
- ClinicalTrials.gov ID
- NCT02968680
- Acronym / sponsor ID
- 10M-15-3
- Conditions
- Cutaneous Melanoma, Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 9 Jan 2020 (actual)
- First posted
- 18 Nov 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 pilot phase I trial studies how well sonazoid-enhanced ultrasound works in detecting sentinel lymph node in patients with cutaneous melanoma. Sonazoid is a contrast agent that may make it easier to see if the tumor cells have spread to the sentinel lymph node using an ultrasound.
Detailed description
PRIMARY OBJECTIVES:
- To study the imaging feasibility of peri-tumoral administration of sonazoid ultrasound contrast agent for assessment of sentinel lymph node (SLN) detection in melanoma.
II. To compare SLN detection between sonazoid ultrasound and standard of care (SOC) technique.
SECONDARY OBJECTIVES:
- To assess the sonazoid ultrasound (US) imaging appearance of lymph nodes which are shown to be involved with metastatic disease.
OUTLINE:
Patients receive sonazoid intradermally (ID) and undergo ultrasound imaging. Patients also undergo standard of care sentinel lymph node biopsy (SLNB).
After completion of study treatment, patients are followed up at 24 and 48 hours.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (sonazoid, ultrasound imaging, SLNB) | Experimental | Procedure: Sentinel Lymph Node Biopsy, Device: Ultrasonography, Drug: SonazoidPatients receive sonazoid ID and undergo ultrasound imaging. Patients also undergo standard of care SLNB. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cutaneous melanoma with Breslow depth > 1 mm or melanoma Breslow depth of 0.76 - 1.00 mm in setting of ulceration, extensive regression
- Mitotic rate >= 1/mm^2
- Presence of angiolymphatic invasion
- Deep positive margin
- No known allergies to contrast material
Key exclusion criteria (11 listed)
- Pregnant or nursing
- Patients with known cardiac shunt
- Patients with class II heart failure or worse, per New York Heart Association (NYHA) classification
- Patients who have experienced an acute coronary syndrome or angina in the past 6 months
- Patients who have undergone coronary artery bypass grafting (CABG) or coronary stenting in the past 3 years
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 |
|---|---|---|
| Sentinel Lymph Node BiopsyAlso: Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNBUndergo SLNB | Procedure or surgery | Diagnostic (sonazoid, ultrasound imaging, SLNB) |
| UltrasonographyAlso: ULTRASOUND, Ultrasound Imaging, Ultrasound Test, Ultrasound, MedicalUndergo sonazoid-enhanced ultrasonography | Device | Diagnostic (sonazoid, ultrasound imaging, SLNB) |
| SonazoidAlso: Contrast ultrasound microvascular perfusion imagingPatients receive sonazoid intradermally (ID) and undergo ultrasound imaging. | Drug | Diagnostic (sonazoid, ultrasound imaging, SLNB) |
Primary outcome
Percent of patients with SLN identified by sonazoid-US alone or both sonazoid-US and conventional methods
Time frame: Up to 1 year
Analyzed using descriptive comparison.
Results and safety
The study was stopped early (reason given: Insufficient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
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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.
Kevin King, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sentinel Lymph Node Biopsy, Ultrasonography and Sonazoid in people with Cutaneous Melanoma and Melanoma, run by University of Southern California 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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 30 Mar 2020. 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 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.
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 was stopped early (reason given: Insufficient accrual). Results are not available in the source record.
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?
Percent of patients with SLN identified by sonazoid-US alone or both sonazoid-US and conventional methods (time frame: Up to 1 year). 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 30 Mar 2020.