Early stage ovarian cancer
Conditions
Interventions
None listed
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Feasibility of Magtrace® as a tracer in SLN sampling in early stage EOC. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Comparison of detection rate between MagTrace® and 99mTc o In the general cohort o In primary staging laparotomy o In secondary staging laparotomy • Detection of potential adverse effects of MagTrace® and 99mTc • Relationship between the observed SLN and the actual number of pathological lymph nodes | — |
Countries
Netherlands
Outcome results
None listed