Trial Outcomes & Findings for Gynecological Sentinel Lymph Nodes CEUS (NCT NCT05105087)
NCT ID: NCT05105087
Last Updated: 2025-08-22
Results Overview
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).
COMPLETED
EARLY_PHASE1
9 participants
up to 30 minutes during CEUS procedure
2025-08-22
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Ineligible for surgery due to advanced disease
|
2
|
Baseline Characteristics
Only patients who completed both CEUS and surgery with SLN excision and pathology evaluation (N=5) were included for analysis.
Baseline characteristics by cohort
| Measure |
Diagnostic (Perflubutane Microbubble, Ultrasound)
n=5 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants • Only patients who completed both CEUS and surgery with SLN excision and pathology evaluation (N=5) were included for analysis.
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants • Only patients who completed both CEUS and surgery with SLN excision and pathology evaluation (N=5) were included for analysis.
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants • Only patients who completed both CEUS and surgery with SLN excision and pathology evaluation (N=5) were included for analysis.
|
|
Age, Continuous
|
55 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants • Only patients who completed both CEUS and surgery with SLN excision and pathology evaluation (N=5) were included for analysis.
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants • Only patients who completed both CEUS and surgery with SLN excision and pathology evaluation (N=5) were included for analysis.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants • Only patients who completed both CEUS and surgery with SLN excision and pathology evaluation (N=5) were included for analysis.
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants • Only patients who completed both CEUS and surgery with SLN excision and pathology evaluation (N=5) were included for analysis.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants • Only patients who completed both CEUS and surgery with SLN excision and pathology evaluation (N=5) were included for analysis.
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants • Only patients who completed both CEUS and surgery with SLN excision and pathology evaluation (N=5) were included for analysis.
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants • Only patients who completed both CEUS and surgery with SLN excision and pathology evaluation (N=5) were included for analysis.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants • Only patients who completed both CEUS and surgery with SLN excision and pathology evaluation (N=5) were included for analysis.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants • Only patients who completed both CEUS and surgery with SLN excision and pathology evaluation (N=5) were included for analysis.
|
PRIMARY outcome
Timeframe: up to 30 minutes during CEUS procedurePopulation: Only participants who completed CEUS and surgery (N=5) were analyzed.
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).
Outcome measures
| Measure |
Diagnostic (Perflubutane Microbubble, Ultrasound)
n=17 sentinel lymph nodes (SLNs)
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
|
|---|---|
|
Number of Sentinel Lymph Nodes (SLNs) Identified by Lymphosonography as Well as Blue Dye or Positron Emission Tomography (PET)-Computed Tomography (CT)
|
17 sentinel lymph nodes (SLNs)
|
SECONDARY outcome
Timeframe: up to 30 minutes during CEUS procedurePopulation: Only participants who completed CEUS and surgery (N=5) were analyzed.
Outcome measures
| Measure |
Diagnostic (Perflubutane Microbubble, Ultrasound)
n=17 sentinel lymph nodes (SLNs)
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
|
|---|---|
|
Location of Sentinel Lymph Nodes (SLNs) Identified by Contrast-enhanced Ultrasound (CEUS)
Left Inguinal Region
|
9 sentinel lymph nodes (SLNs)
|
|
Location of Sentinel Lymph Nodes (SLNs) Identified by Contrast-enhanced Ultrasound (CEUS)
Left Iliac Region
|
7 sentinel lymph nodes (SLNs)
|
|
Location of Sentinel Lymph Nodes (SLNs) Identified by Contrast-enhanced Ultrasound (CEUS)
Right Iliac Region
|
1 sentinel lymph nodes (SLNs)
|
SECONDARY outcome
Timeframe: up to 30 minutes during CEUS procedurePopulation: Only participants who completed CEUS and surgery (N=5) were analyzed.
The locations, depth beneath the skin surface and size (measured in three orthogonal dimensions) of each SLN will be recorded.
Outcome measures
| Measure |
Diagnostic (Perflubutane Microbubble, Ultrasound)
n=17 sentinel lymph nodes (SLNs)
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
|
|---|---|
|
Size of Sentinel Lymph Nodes (SLNs) Identified
|
1.6 centimeters (cm)
Interval 0.7 to 2.4
|
SECONDARY outcome
Timeframe: up to 30 minutes during CEUS procedurePopulation: Only participants who completed CEUS and surgery (N=5) were analyzed.
The locations, depth beneath the skin surface and size (measured in three orthogonal dimensions) of each SLN will be recorded - \[this verbiage comes directly from the protocol\]
Outcome measures
| Measure |
Diagnostic (Perflubutane Microbubble, Ultrasound)
n=17 sentinel lymph nodes (SLNs)
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
|
|---|---|
|
Depth Beneath the Skin Surface of Each SLN
|
2.71 centimeters (cm)
Interval 0.5 to 6.0
|
SECONDARY outcome
Timeframe: Within 7 days post-surgeryPopulation: Only participants who completed CEUS and surgery (N=5) were analyzed.
The presence or absence of metastatic deposits in SLNs will be obtained by pathology (when available).
Outcome measures
| Measure |
Diagnostic (Perflubutane Microbubble, Ultrasound)
n=11 sentinel lymph nodes (SLNs)
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
|
|---|---|
|
Presence of Metastatic Deposits in the Sentinel Lymph Node (SLNs)
|
3 Metastatic sentinel lymph nodes (SLNs)
|
Adverse Events
Diagnostic (Perflubutane Microbubble, Ultrasound)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place