Clinical trial · Interventional
Gynecological Sentinel Lymph Nodes CEUS
Detection of Sentinel Lymph Nodes in Female Lower Genital Tract Cancer Patients With Contrast-Enhanced Ultrasound Imaging
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Carcinoma | Cervical Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Female Reproductive System Neoplasm | Malignant Female Reproductive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Vaginal Carcinoma | Vaginal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Vulvar Carcinoma | Vulvar Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast-Enhanced Ultrasound | Procedure | — | UNRESOLVED |
| Perflubutane Microbubble | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (perflubutane microbubble, ultrasound)
- description
- Patients receive perflubutane microbubble injections subdermally and then undergo ultrasound over 30 minutes before standard of care cancer treatment.
- interventionNames
- Drug: Perflubutane Microbubble
- Procedure: Contrast-Enhanced Ultrasound
Primary outcomes (1)
- measure
- Number of Sentinel Lymph Nodes (SLNs) Identified by Lymphosonography as Well as Blue Dye or Positron Emission Tomography (PET)-Computed Tomography (CT)
- timeFrame
- up to 30 minutes during CEUS procedure
- description
- 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).
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 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 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 * 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)
References
Publications (0)
Data not yet available