NCT05105087CompletedEarly phase 1
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 · Last updated 22 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 13 Aug 2021
- Start date
- 28 Apr 2022
- Primary completion date
- 15 Nov 2023
- Lead sponsor
- Thomas Jefferson University
- Diseases
- Cervical cancer
- NCT number
- NCT05105087
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 9
- From 28 Apr 2022 to the primary completion date, 15 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Patients with congenital heart defects
- Patient with a known allergy to Sonazoid (including an anaphylactic allergy to eggs or egg products)
Other
- Females who are pregnant or nursing
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.