Magtrial: MagtraceĀ® as Tracer for Sentinel Lymph Node Detection in Early Stage Epithelial Ovarianā¦ (NCT05375526) | Clinical Trial Compass
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Magtrial: MagtraceĀ® as Tracer for Sentinel Lymph Node Detection in Early Stage Epithelial Ovarian Cancer
Netherlands10 participantsStarted 2022-06-01
Plain-language 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 per 100.000, with 12.3 deaths per 100.000. In the US in 2007 the incidence was 13.0 per 100.000 and there were 8.2 deaths per 100.000. The high mortality rate is partially due to the fact that approximately 75% of patients is diagnosed with advanced stage EOC. The remaining 25% of patients are diagnosed in an early stage, which require a complete surgical staging procedure including pelvic and para-aortic lymphadenectomy. Although this lymphadenectomy is standard-of-care, it leads to significant morbidity in these patients. Mainly direct postoperative complications such as infection, repeat surgery and early death have been reported. Also, long-term complications such as lymph cysts or lymphedema have been described.
A potential method to reduce this morbidity and mortality, as already been described in other cancers such as breast cancer and vulvar cancer, is utilizing a sentinel lymph node (SLN) technique. By identifying and resecting the SLN, the patient is potentially spared form lymphadenectomy.
Who can participate
Age range18 Years ā 85 Years
SexFEMALE
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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 MagtraceĀ®.
* 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 proceduresā¦
What they're measuring
1
To assess the use of MagtraceĀ® as a tracer in SLN sampling in early stage EOC