Magtrace® as tracer for sentinel lymph node detection in early stage epithelial ovarian cancer: a pilot study
- Conditions
- Early stage ovarian cancer10038594
- Registration Number
- NL-OMON54285
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
Patients with a high suspicion of an early stage malignant EOC planned for
exploratory laparotomy.
Patients with a confirmed early stage malignant EOC where a secondary staging
laparotomy will be performed
Age between 18 and 85 years
Secondary staging laparotomy for stage I expansile type mucinous adenocarcinoma.
Patients with suspicion of positive lymph nodes in the inguinal, pelvic, para
aortal or other
lymph regions (either clinically or radiographically).
Patients with suspicion of metastasis (either clinically or radiographically).
Patients with previous ovarian surgery.
Patients with previous vascular surgery of the aorta,
inferior vena cava, and/or iliac vessels.
Patients with previous lymphadenectomy of lymph node sampling in the iliac or
paraaortal
region.
Patients with history of a malignant lymphoma.
Patients with history of a malignant tumour in the abdominal cavity
other than EOC
Patients who are pregnant or lactating.
Patients with an allergy for human albumin
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Feasibility of Magtrace® as a tracer in SLN sampling in early stage EOC.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Comparison of detection rate between MagTrace® and 99mTc<br /><br>o In the general cohort<br /><br>o In primary staging laparotomy<br /><br>o In secondary staging laparotomy<br /><br>• Detection of potential adverse effects of MagTrace® and 99mTc<br /><br>• Relationship between the observed SLN and the actual number of pathological<br /><br>lymph nodes</p><br>