Status:
UNKNOWN
Magtrial: Magtrace® as Tracer for Sentinel Lymph Node Detection in Early Stage Epithelial Ovarian Cancer
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Ovarian Cancer
Lymph Node Metastasis
Eligibility:
FEMALE
18-85 years
Phase:
NA
Brief Summary
Epithelial ovarian cancer (EOC) remains the tumour with the most unfavourable prognosis within the field of gynaecological oncology. The incidence of ovarian cancer in the Netherlands in 2008 was 14.5...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05375526
Start Date
June 1 2022
End Date
October 1 2024
Last Update
May 16 2022
Active Locations (1)
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1
Maastricht UMC
Maastricht, Limburg, Netherlands, 6229 HX