Magtrial: Magtrace® as Tracer for Sentinel Lymph Node Detection in Early Stage Epithelial Ovarian Cancer

Launched by MAASTRICHT UNIVERSITY MEDICAL CENTER · May 10, 2022

Keywords

ClinConnect Summary

Background EOC can metastasize through three different pathways: intraperitoneal (in the abdominal cavity), lymphogenous or haematogenous \[5,6\]. Concerning the lymphogenous spread, it is clear that lymphatic spread of EOC occurs mainly to the para-aortic lymph nodes. It is theorized that the tumour cells follow the lymph vessels that accompany the ovarian vessels in the infundibulopelvic ligament up to the upper para-aortic region and renal vein. Additionally, pelvic lymph node metastases are also frequently found. These tumour cells probably follow a different route, migrating via the pa...

Gender

FEMALE

Eligibility 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:
• • 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 para-aortal 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.
• • Patients have had preoperative radiation therapy to the pelvis.
• • Patients with an iron overload disease.
• • Patients with intolerance or hypersensitivity to iron or dextran compounds or to Magtrace®.
• • Patients with a metal implant close to the expected sentinel lymph node location.
• • Patients who are deprived of liberty or under guardianship.
• • Patients not able to follow and understand the procedures of the study due to mental state or other reasons.