Microbubbles groin ultrasound study

To determine the feasibility of using Microbubble technology to detect sentinel nodes in vulvar cancer. - Microbubbles in vulvar cancer

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000988-25-GB

Enrollment

Registered

2012-03-09

Start date

2012-04-27

Completion date

Unknown

Last updated

2013-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early stage vulvar cancer with no clinial or radiological evidence of lymph node metastases

Interventions

Trade Name: SonoVue Product Name: SonoVue Pharmaceutical Form: Powder and solvent for dispersion for injection INN or Proposed INN: sulphur hexafluoride Current Sponsor code: version4 Concentration un

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Confirmed carcinoma of the vulva requiring surgical groin node dissection 2. Patients willing to consent to the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: 1. Patients enrolled in another trial, for example GROINSS-V-II 2. Clinically or radiologically suspicious lymph nodes 3. Previous surgery or radiotherapy to the groin area – risk of lymph vessel damage 4. Patients with known hypersensitivity to sulphur hexafluoride, pregnant or lactating women, and patients in extreme ill health (recent acute coronary syndrome, clinically unstable ischaemic heart disease, acute or class III/IV cardiac failure, right to left cardiac shunts, severe pulmonary hypertension, uncontrolled sysytemic hypertension, adult respiratory distress syndrome)

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the feasibility of using Microbubble technology to detect sentinel nodes in vulvar cancer 1. Identification of one or more inguinofemoral lymph nodes 2. Correct intraoperative identification of the sentinel node as verified by Technetium 99m & patent blue dye ;Secondary Objective: 1. Operative time 2. Cost of procedure ;Primary end point(s): Recruitment of at least 10 patients;Timepoint(s) of evaluation of this end point: 24 months	—

Measure

Time frame

Main Objective: To determine the feasibility of using Microbubble technology to detect sentinel nodes in vulvar cancer 1. Identification of one or more inguinofemoral lymph nodes 2. Correct intraoperative identification of the sentinel node as verified by Technetium 99m & patent blue dye ;Secondary Objective: 1. Operative time 2. Cost of procedure ;Primary end point(s): Recruitment of at least 10 patients;Timepoint(s) of evaluation of this end point: 24 months

—

Secondary

Measure	Time frame
Secondary end point(s): Serious adverse event directly linked to SonoVue administration;Timepoint(s) of evaluation of this end point: At any point during the trial	—

Countries

United Kingdom

Contacts

Public ContactDr Nithya Ratnavelu

Northern Gynaecological Oncology Centre, Gateshead

nithya.ratnavelu@ghnt.nhs.uk4401914456136

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026