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| ID | Type | Description | Link |
|---|---|---|---|
| R21CA249870 | U.S. NIH Grant/Contract | View source | |
| JT 16886 | Other Identifier | JeffTrial Number |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
PRIMARY OBJECTIVES:
I. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (perflubutane microbubble, ultrasound) | Experimental | Patients receive perflubutane microbubble injections subdermally and then undergo ultrasound over 30 minutes before standard of care cancer treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perflubutane Microbubble | Drug | Given subdermally |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | up to 30 minutes during CEUS procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Location of Sentinel Lymph Nodes (SLNs) Identified by Contrast-enhanced Ultrasound (CEUS) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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)
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| Name | Affiliation | Role |
|---|---|---|
| Ji-Bin Liu, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
Screening assessments were performed within 4 weeks prior to the administration of Sonazoid. A full demographic profile, known drug allergies or intolerances, and a review of the subject's medical/surgical history were recorded.
9 participants received CEUS. 5 completed both CEUS and surgery with pathology and were analyzed. 2 were ineligible for surgery (advanced disease), and 2 withdrew consent prior to surgery; thus no outcome data were available for these 4 participants.
This was a single-site, open-label, non-randomized pilot study conducted at Thomas Jefferson University (TJU), Sidney Kimmel Cancer Center, Philadelphia, PA. Subject recruitment was expected to last 24 months, beginning in April 2022 and ending in November 2023. Recruitment was conducted from the patient population of the Department of Gynecology Oncology at TJU. Eligible participants were identified by surgical co-investigators from their existing patient population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (Perflubutane Microbubble, Ultrasound) | Patients receive perflubutane microbubble injections subdermally and then undergo ultrasound over 30 minutes before standard of care cancer treatment. Perflubutane Microbubble: Given subdermally Contrast-Enhanced Ultrasound: Undergo ultrasound |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (Perflubutane Microbubble, Ultrasound) | Patients receive perflubutane microbubble injections subdermally and then undergo ultrasound over 30 minutes before standard of care cancer treatment. Perflubutane Microbubble: Given subdermally Contrast-Enhanced Ultrasound: Undergo ultrasound |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Only patients who completed both CEUS and surgery with SLN excision and pathology evaluation (N=5) were included for analysis. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Only participants who completed CEUS and surgery (N=5) were analyzed. | Posted | Number | sentinel lymph nodes (SLNs) | up to 30 minutes during CEUS procedure | sentinel lymph nodes (SLNs) | sentinel lymph nodes (SLNs) |
|
The PI will follow AEs with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Events will be followed for outcome information until resolution or stabilization.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diagnostic (Perflubutane Microbubble, Ultrasound) | Patients receive perflubutane microbubble injections subdermally and then undergo ultrasound over 30 minutes before standard of care cancer treatment. Perflubutane Microbubble: Given subdermally Contrast-Enhanced Ultrasound: Undergo ultrasound |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ji-Bin Liu, MD | Thomas Jefferson University | 215-955-4862 | jxl120@jefferson.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 29, 2023 | Jun 19, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D014625 | Vaginal Neoplasms |
| D014846 | Vulvar Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C069727 | Sonazoid |
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| Contrast-Enhanced Ultrasound | Procedure | Undergo ultrasound |
|
|
| 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] | 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). | Within 7 days post-surgery |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Only patients who completed both CEUS and surgery with SLN excision and pathology evaluation (N=5) were included for analysis. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Only patients who completed both CEUS and surgery with SLN excision and pathology evaluation (N=5) were included for analysis. | Count of Participants | Participants |
|
|
|
| Secondary | Location of Sentinel Lymph Nodes (SLNs) Identified by Contrast-enhanced Ultrasound (CEUS) | Only participants who completed CEUS and surgery (N=5) were analyzed. | Posted | Number | sentinel lymph nodes (SLNs) | up to 30 minutes during CEUS procedure | sentinel lymph nodes (SLNs) | sentinel lymph nodes (SLNs) |
|
|
|
| Secondary | 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. | Only participants who completed CEUS and surgery (N=5) were analyzed. | Posted | Mean | Full Range | centimeters (cm) | up to 30 minutes during CEUS procedure | sentinel lymph nodes (SLNs) | sentinel lymph nodes (SLNs) |
|
|
|
| Secondary | 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] | Only participants who completed CEUS and surgery (N=5) were analyzed. | Posted | Mean | Full Range | centimeters (cm) | up to 30 minutes during CEUS procedure | sentinel lymph nodes (SLNs) | sentinel lymph nodes (SLNs) |
|
|
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| Secondary | 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). | Only participants who completed CEUS and surgery (N=5) were analyzed. | Posted | Number | Metastatic sentinel lymph nodes (SLNs) | Within 7 days post-surgery | sentinel lymph nodes (SLNs) | sentinel lymph nodes (SLNs) |
|
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| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014623 | Vaginal Diseases |
| D014845 | Vulvar Diseases |
| Title | Measurements |
|---|---|
|