Cervical CarcinomaEarly Phase 1NCT05105087
Gynecological Sentinel Lymph Nodes CEUS
A Early Phase 1 study testing Perflubutane Microbubble and Contrast-Enhanced Ultrasound in people with Cervical Carcinoma and Malignant Female Reproductive System Neoplasm, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This clinical trial compares the use of ultrasound for the detection of sentinel lymph nodes (SLNs) to the standard of care (which varies depending on cancer treatment). The ultrasound contrast agent is called Sonazoid and it consists of tiny gas-filled bubbles about the side of red blood cells. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Carcinoma, Malignant Female Reproductive System Neoplasm, Vaginal Carcinoma
- What is being tested?
- Perflubutane Microbubble and Contrast-Enhanced Ultrasound
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2022to 29 Jan 2025
- Phase
- Early Phase 1
- 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
- Be female
- Be diagnosed with cervical, vaginal or vulvar cancer
- Be at least 18 years of age
- If of child-bearing potential, must have a negative pregnancy test
- Be able to comply with study procedures
- Have read and signed the Institutional Review Board (IRB)-approved informed consent form for participating in the study
Who cannot join
- Females who are pregnant or nursing
- Patients who have received an investigational drug in the 30 days before study drug administration, or will receive one within 72 hours afterwards
- 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 clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia
- Patients with recent cerebral hemorrhage
Show all 9Show fewer
- Patients who have undergone surgery within 24 hours prior to the study sonographic examination
- Patients with congenital heart defects
- Patient with a known allergy to Sonazoid (including an anaphylactic allergy to eggs or egg products)
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
Official title: Detection of Sentinel Lymph Nodes in Female Lower Genital Tract Cancer Patients With Contrast-Enhanced Ultrasound Imaging
This clinical trial compares the use of ultrasound for the detection of sentinel lymph nodes (SLNs) to the standard of care (which varies depending on cancer treatment). The ultrasound contrast agent is called Sonazoid and it consists of tiny gas-filled bubbles about the side of red blood cells. Diagnostic procedures, such as ultrasound with Sonazoid, may help identify more SLNs than standard of care in patients with cervical, vaginal, or vulvar cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the concordance between lymphosonography and the standard of care in the identification sentinel lymph nodes (SLNs) in patients with cervical, vaginal or vulvar cancer.
II. To determine if lymphosonography can identify more SLNs with metastatic deposits in patients with cervical, vaginal or vulvar cancer when compared to the standard of care.
OUTLINE:
Patients receive perflubutane microbubble (Sonazoid) injections subdermally and then undergo ultrasound over 30 minutes before standard of care cancer treatment.
After completion of study intervention, patients are followed up for 30 days.
- Conditions
- Cervical Carcinoma, Malignant Female Reproductive System Neoplasm, Vaginal Carcinoma, Vulvar Carcinoma
- Being tested
- Perflubutane Microbubble, Contrast-Enhanced Ultrasound
- Medical subject headings
- Uterine Cervical Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perflubutane MicrobubbleDrug
Also called Sonazoid, gas-filled microbubbles
Given subdermally
Contrast-Enhanced UltrasoundProcedure or surgery
Also called CEUS
Undergo ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (perflubutane microbubble, ultrasound) | Experimental | Patients receive perflubutane microbubble injections subdermally and then undergo ultrasound over 30 minutes before standard of care cancer treatment. Receives: Drug: Perflubutane Microbubble; Procedure: Contrast-Enhanced Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Sentinel Lymph Nodes (SLNs) Identified by Lymphosonography as Well as Blue Dye or Positron Emission Tomography (PET)-Computed Tomography (CT)
The number of SLN detected by contrast enhanced ultrasound will be compared to the number of SLN detected by the standard of care (i.e., by blue dye or by PET-CT).
Measured: up to 30 minutes during CEUS procedure
Secondary outcomes (4)
Location of Sentinel Lymph Nodes (SLNs) Identified by Contrast-enhanced Ultrasound (CEUS)
Measured: up to 30 minutes during CEUS procedure
Size of Sentinel Lymph Nodes (SLNs) Identified
The locations, depth beneath the skin surface and size (measured in three orthogonal dimensions) of each SLN will be recorded.
Measured: up to 30 minutes during CEUS procedure
Depth Beneath the Skin Surface of Each SLN
The locations, depth beneath the skin surface and size (measured in three orthogonal dimensions) of each SLN will be recorded - [this verbiage comes directly from the protocol]
Measured: up to 30 minutes during CEUS procedure
Presence of Metastatic Deposits in the Sentinel Lymph Node (SLNs)
The presence or absence of metastatic deposits in SLNs will be obtained by pathology (when available).
Measured: Within 7 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start28 Apr 2022
- Primary completion15 Nov 2023
- Study completion29 Jan 2025
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 Cervical CarcinomaStudies 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ji-Bin Liu, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105087
- Sponsor's protocol ID
- 21F.624
- Other IDs
- R21CA249870, JT 16886
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2021
- Last updated
- 22 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Sentinel Lymph Nodes in Female Lower Genital Tract Cancer Patients With Contrast-Enhanced Ultrasound Imaging
- ClinicalTrials.gov ID
- NCT05105087
- Acronym / sponsor ID
- 21F.624
- Conditions
- Cervical Carcinoma, Malignant Female Reproductive System Neoplasm, Vaginal Carcinoma, Vulvar Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 29 Jan 2025 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Posted 22 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial compares the use of ultrasound for the detection of sentinel lymph nodes (SLNs) to the standard of care (which varies depending on cancer treatment). The ultrasound contrast agent is called Sonazoid and it consists of tiny gas-filled bubbles about the side of red blood cells. Diagnostic procedures, such as ultrasound with Sonazoid, may help identify more SLNs than standard of care in patients with cervical, vaginal, or vulvar cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine the concordance between lymphosonography and the standard of care in the identification sentinel lymph nodes (SLNs) in patients with cervical, vaginal or vulvar cancer.
II. To determine if lymphosonography can identify more SLNs with metastatic deposits in patients with cervical, vaginal or vulvar cancer when compared to the standard of care.
OUTLINE:
Patients receive perflubutane microbubble (Sonazoid) injections subdermally and then undergo ultrasound over 30 minutes before standard of care cancer treatment.
After completion of study intervention, patients are followed up for 30 days.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (perflubutane microbubble, ultrasound) | Experimental | Drug: Perflubutane Microbubble, Procedure: Contrast-Enhanced UltrasoundPatients receive perflubutane microbubble injections subdermally and then undergo ultrasound over 30 minutes before standard of care cancer treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be female
- Be diagnosed with cervical, vaginal or vulvar cancer
- Be at least 18 years of age
- If of child-bearing potential, must have a negative pregnancy test
- Be able to comply with study procedures
Key exclusion criteria (9 listed)
- Females who are pregnant or nursing
- Patients who have received an investigational drug in the 30 days before study drug administration, or will receive one within 72 hours afterwards
- Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
- Patients with congenital heart defects
- Patient with a known allergy to Sonazoid (including an anaphylactic allergy to eggs or egg products)
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 |
|---|---|---|
| Perflubutane MicrobubbleAlso: Sonazoid, gas-filled microbubblesGiven subdermally | Drug | Diagnostic (perflubutane microbubble, ultrasound) |
| Contrast-Enhanced UltrasoundAlso: CEUSUndergo ultrasound | Procedure or surgery | Diagnostic (perflubutane microbubble, ultrasound) |
Primary outcome
Number of Sentinel Lymph Nodes (SLNs) Identified by Lymphosonography as Well as Blue Dye or Positron Emission Tomography (PET)-Computed Tomography (CT)
Time frame: up to 30 minutes during CEUS procedure
The number of SLN detected by contrast enhanced ultrasound will be compared to the number of SLN detected by the standard of care (i.e., by blue dye or by PET-CT).
4 secondary outcomes
Location of Sentinel Lymph Nodes (SLNs) Identified by Contrast-enhanced Ultrasound (CEUS)
Time frame: up to 30 minutes during CEUS procedure
Size of Sentinel Lymph Nodes (SLNs) Identified
Time frame: up to 30 minutes during CEUS procedure
Depth Beneath the Skin Surface of Each SLN
Time frame: up to 30 minutes during CEUS procedure
Presence of Metastatic Deposits in the Sentinel Lymph Node (SLNs)
Time frame: Within 7 days post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
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 Perflubutane Microbubble and Contrast-Enhanced Ultrasound in people with Cervical Carcinoma and Malignant Female Reproductive System Neoplasm, run by 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 9 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 22 Aug 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?
Yes. Results are posted in the registry (first posted 22 Aug 2025). 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 Sentinel Lymph Nodes (SLNs) Identified by Lymphosonography as Well as Blue Dye or Positron Emission Tomography (PET)-Computed Tomography (CT) (time frame: up to 30 minutes during CEUS procedure). 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 22 Aug 2025.