EsophagusEarly Phase 1NCT03578224
Contrast-Enhanced Ultrasound Identification of Sentinel Nodes in Esophageal Cancer
A Early Phase 1 study testing Endoscopic Ultrasound-Guided Fine-Needle Aspiration (EUS-FNA), Contrast-Enhanced Ultrasound and Fine-Needle Aspiration in people with Esophagus, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
This pilot trial studies how well an ultrasound with a contrast agent (perflubutane microbubble [Sonazoid]) works in identifying sentinel lymph nodes in participants with esophageal cancer. Sentinel lymph nodes are lymph nodes to which the cancer is likely to spread from the primary tumor. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Esophagus
- What is being tested?
- Endoscopic Ultrasound-Guided Fine-Needle Aspiration (EUS-FNA), Contrast-Enhanced Ultrasound and Fine-Needle Aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2018to 25 Aug 2022
- Phase
- Early 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed with esophageal cancer.
- Be scheduled for staging endoscopic ultrasound with the intent for lymph node evaluation.
- Provide signed and dated informed consent form.
- Willing to comply with all study procedures and be available for the duration of the study.
- Be medically stable.
- If a female and pre-menopausal, must have a negative pregnancy test.
Who cannot join
- Females who are pregnant or nursing.
- 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.
- Patients with known hypersensitivity or allergy to any component of Sonazoid.
- Patients with cardiac shunts or unstable cardiopulmonary conditions.
- Patients with congenital heart defects.
- Patients with severe emphysema, pulmonary vasculitis, pulmonary hypertension, respiratory distress syndrome, or a history of pulmonary embolism.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
This pilot trial studies how well an ultrasound with a contrast agent (perflubutane microbubble [Sonazoid]) works in identifying sentinel lymph nodes in participants with esophageal cancer. Sentinel lymph nodes are lymph nodes to which the cancer is likely to spread from the primary tumor. Diagnostic procedures, such as contrast-enhanced ultrasound, may work better in identifying sentinel lymph nodes and finding out how far the disease has spread.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the accuracy of contrast-enhanced endoscopic lymphosonography guided fine-needle aspiration (FNA) of sentinel lymph nodes compared with unenhanced endoscopic ultrasonography (EUS) guided FNA in the characterization of esophageal cancer-associated lymph nodes using pathology as the reference standard.
SECONDARY OBJECTIVES:
- To assess the ability of contrast-enhanced endoscopic lymphosonography guided FNA compared with unenhanced EUS guided FNA in the overall detection of biopsy proven cancer-involved sentinel lymph nodes.
II. To assess the impact of overall tumor staging by contrast-enhanced endoscopic lymphosonography compared with unenhanced EUS.
- Conditions
- Esophagus
- Being tested
- Endoscopic Ultrasound-Guided Fine-Needle Aspiration (EUS-FNA), Contrast-Enhanced Ultrasound, Fine-Needle Aspiration, Sonazoid (Perflubutane)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Ultrasound-Guided Fine-Needle Aspiration (EUS-FNA)Procedure or surgery
Undergo EUS-FNA
Contrast-Enhanced UltrasoundProcedure or surgery
Undergo CEUS
Fine-Needle AspirationProcedure or surgery
Undergo FNA
Sonazoid (Perflubutane)Drug
Sonazoid (ultrasound contrast agent) will be injected in 0.25 mL increments at 12, 3, 6, and 9 o'clock positions around the tumor using a 19 - 22 gauge needle system under EUS guidance
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (EUS, FNA, perflubutane microbubble) | Experimental | Participants undergo standard of care unenhanced endoscopic ultrasound (EUS) and fine needle aspiration (FNA) of identified lymph nodes. Participants then receive perflubutane microbubble peri- or intratumorally and undergo contrast-enhanced EUS followed by FNA of identified lymph nodes. Receives: Procedure: Endoscopic Ultrasound-Guided Fine-Needle Aspiration (EUS-FNA); Procedure: Contrast-Enhanced Ultrasound; Procedure: Fine-Needle Aspiration; Drug: Sonazoid (Perflubutane) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy rate of traditional endoscopic ultrasonography (EUS) with suspicious node biopsy and lymphosonography for sentinel node identification
The number and locations of the nodes identified by the two imaging approaches (contrast-enhanced ultrasound [CEUS] and unenhanced EUS) will be compared using McNemar's test for correlated proportions as well as using a one-sided t-test with a Wilcoxon non-parametric adjustment (normal distribution will be tested) with pathology as the reference standard for sentinel lymph node detection and considering exact binomial p-values less than 0.05 to be significant. The findings of lymphosonography will be correlated to pathological findings (including degree of metastatic involvement) to determine sensitivity and specificity and the rate of cancerous nodes identified by CEUS relative to those of unenhanced EUS using a clustered conditional logistic regression analysis of correlated proportions (equivalent to a clustered McNemar's test).
Measured: Up to 2 years
Secondary outcomes (1)
Number of nodes identified
The number and locations of the nodes identified by the two imaging approaches (CEUS and unenhanced EUS) will be compared using McNemar's test for correlated proportions as well as using a one-sided t-test with a Wilcoxon non-parametric adjustment (normal distribution will be tested) with pathology as the reference standard for sentinel lymph node detection and considering exact binomial p-values less than 0.05 to be significant. The findings of lymphosonography will be correlated to pathological findings (including degree of metastatic involvement) to determine sensitivity and specificity and the rate of cancerous nodes identified by CEUS relative to those of unenhanced EUS using a clustered conditional logistic regression analysis of correlated proportions (equivalent to a clustered McNemar's test).
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start6 Sep 2018
- Primary completion25 Aug 2022
- Study completion25 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsophagusStudies 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 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)
- Responsible party
- Sponsor
- Investigators
- Ji-Bin Liu, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578224
- Sponsor's protocol ID
- 18F.235
- Other IDs
- R21CA218946, JT 12449
- Status last verified
- May 2025
- First submitted
- 25 Jun 2018
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-Enhanced Ultrasound Identification of Sentinel Nodes in Esophageal Cancer
- ClinicalTrials.gov ID
- NCT03578224
- Acronym / sponsor ID
- 18F.235
- Conditions
- Esophagus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Sep 2018 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 6 Jul 2018 (actual)
- 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 trial studies how well an ultrasound with a contrast agent (perflubutane microbubble [Sonazoid]) works in identifying sentinel lymph nodes in participants with esophageal cancer. Sentinel lymph nodes are lymph nodes to which the cancer is likely to spread from the primary tumor. Diagnostic procedures, such as contrast-enhanced ultrasound, may work better in identifying sentinel lymph nodes and finding out how far the disease has spread.
Detailed description
PRIMARY OBJECTIVES:
- To assess the accuracy of contrast-enhanced endoscopic lymphosonography guided fine-needle aspiration (FNA) of sentinel lymph nodes compared with unenhanced endoscopic ultrasonography (EUS) guided FNA in the characterization of esophageal cancer-associated lymph nodes using pathology as the reference standard.
SECONDARY OBJECTIVES:
- To assess the ability of contrast-enhanced endoscopic lymphosonography guided FNA compared with unenhanced EUS guided FNA in the overall detection of biopsy proven cancer-involved sentinel lymph nodes.
II. To assess the impact of overall tumor staging by contrast-enhanced endoscopic lymphosonography compared with unenhanced EUS.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (EUS, FNA, perflubutane microbubble) | Experimental | Procedure: Endoscopic Ultrasound-Guided Fine-Needle Aspiration (EUS-FNA), Procedure: Contrast-Enhanced Ultrasound, Procedure: Fine-Needle Aspiration, Drug: Sonazoid (Perflubutane)Participants undergo standard of care unenhanced endoscopic ultrasound (EUS) and fine needle aspiration (FNA) of identified lymph nodes. Participants then receive perflubutane microbubble peri- or intratumorally and undergo contrast-enhanced EUS followed by FNA of identified lymph nodes. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Newly diagnosed with esophageal cancer.
- Be scheduled for staging endoscopic ultrasound with the intent for lymph node evaluation.
- Provide signed and dated informed consent form.
- Willing to comply with all study procedures and be available for the duration of the study.
- Be medically stable.
Key exclusion criteria (7 listed)
- Females who are pregnant or nursing.
- 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.
- Patients with known hypersensitivity or allergy to any component of Sonazoid.
- Patients with cardiac shunts or unstable cardiopulmonary conditions.
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 |
|---|---|---|
| Endoscopic Ultrasound-Guided Fine-Needle Aspiration (EUS-FNA)Undergo EUS-FNA | Procedure or surgery | Diagnostic (EUS, FNA, perflubutane microbubble) |
| Contrast-Enhanced UltrasoundUndergo CEUS | Procedure or surgery | Diagnostic (EUS, FNA, perflubutane microbubble) |
| Fine-Needle AspirationUndergo FNA | Procedure or surgery | Diagnostic (EUS, FNA, perflubutane microbubble) |
| Sonazoid (Perflubutane)Sonazoid (ultrasound contrast agent) will be injected in 0.25 mL increments at 12, 3, 6, and 9 o'clock positions around the tumor using a 19 - 22 gauge needle system under EUS guidance | Drug | Diagnostic (EUS, FNA, perflubutane microbubble) |
Primary outcome
Accuracy rate of traditional endoscopic ultrasonography (EUS) with suspicious node biopsy and lymphosonography for sentinel node identification
Time frame: Up to 2 years
The number and locations of the nodes identified by the two imaging approaches (contrast-enhanced ultrasound [CEUS] and unenhanced EUS) will be compared using McNemar's test for correlated proportions as well as using a one-sided t-test with a Wilcoxon non-parametric adjustment (normal distribution will be tested) with pathology as the reference standard for sentinel lymph node detection and considering exact binomial p-values less than 0.05 to be significant. The findings of lymphosonography will be correlated to pathological findings (including degree of metastatic involvement) to determine sensitivity and specificity and the rate of cancerous nodes identified by CEUS relative to those of unenhanced EUS using a clustered conditional logistic regression analysis of correlated proportions (equivalent to a clustered McNemar's test).
1 secondary outcome
Number of nodes identified
Time frame: Up to 2 years
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 18 May 2025.
- Thomas Jefferson University HospitalLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ji-Bin Liu, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at 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 Early Phase 1 study testing Endoscopic Ultrasound-Guided Fine-Needle Aspiration (EUS-FNA), Contrast-Enhanced Ultrasound and Fine-Needle Aspiration in people with Esophagus, 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 6 inclusion and 7 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 18 May 2025. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Accuracy rate of traditional endoscopic ultrasonography (EUS) with suspicious node biopsy and lymphosonography for sentinel node identification (time frame: Up to 2 years). 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 18 May 2025.