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

NCT05375526 | Unknown DMC

• 1 other identifier: NL75863.068.21
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Ovarian Cancer; Lymph Node Metastasis

Keywords

Sentinel lymph node

Outcome Measures

Primary Outcomes (1)

• To assess the use of Magtrace® as a tracer in SLN sampling in early stage EOC

  Can sentinel lymph nodes be found using magtrace this means a positive signal. The patient will have a interpatient control using radio active technetium. Outcome will be reported as: Magtrace found sentinel lymph node: yes or no

  2 years

Secondary Outcomes (3)

• Comparison of detection rate between MagTrace® and 99mTc

  2 years

• Detection of potential adverse effects of MagTrace® and 99mTc

  2 years

• Relationship between the observed SLN and the actual number of pathological lymphnodes

  2 years

Study Arms (2)

Primary staging laparotomy for suspicion of early stage EOC

EXPERIMENTAL

In case of a primary staging laparotomy the diagnosis of malignancy is based on a frozen section of the resected adnexa, followed by the sentinel node technique during the same procedure.

Device: Magtrace

Secondary staging laparotomy for EOC

EXPERIMENTAL

On the other hand, in some cases early stage EOC is only diagnosed after the primary surgery, when the surgeon resects the ovary with the suspicion of benign disease. If the adnexa are already removed before the diagnosis of malignancy, a secondary staging laparotomy is required and, in this case, a single step approach for SLN is not feasible.

Device: Magtrace

Interventions

Magtrace DEVICE

In the proper ovarian ligament (or its remnants), close to the ovary and just below the peritoneum Magtrace® will be injected via a 12 Gauge (2mm) needle. This injection will be followed by an injection of 20 MBq 99mTc via the same 12 Gauge (2mm) needle. If a hysterectomy has been conducted, this step can be omitted. In the infundibulopelvic ligament (suspensory ligament of the ovary), close to the ovary and just below the peritoneum Magtrace® will be injected via a 12 Gauge (2mm) needle. This injection will be followed by an injection of 20 MBq 99mTc via the same 12 Gauge (2mm) needle.

Primary staging laparotomy for suspicion of early stage EOC; Secondary staging laparotomy for EOC

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Ovarian cancer is a female only disease
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (1)

Maastricht UMC

Maastricht, Limburg, 6229 HX, Netherlands

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot trial

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 16, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

NL (1)