Microbubbles groin ultrasound study

Conditions: Early stage vulvar cancer with no clinial or radiological evidence of lymph node metastases
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-000988-25-GB

Lead Sponsor: Gateshead Health NHS Trust Research & Development

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 15

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

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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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