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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05375526
Recruitment Status : Not yet recruiting
First Posted : May 16, 2022
Last Update Posted : May 16, 2022
Sponsor:
Collaborator:
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Maastricht University Medical Center

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.


Condition or disease Intervention/treatment Phase
Ovarian Cancer Lymph Node Metastasis Device: Magtrace Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pilot trial
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Magtrace® as Tracer for Sentinel Lymph Node Detection in Early Stage Epithelial Ovarian Cancer: a Pilot Study
Estimated Study Start Date : June 1, 2022
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : October 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: Primary staging laparotomy for suspicion of early stage EOC
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

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.


Experimental: Secondary staging laparotomy for EOC
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

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 Outcome Measures :
  1. To assess the use of Magtrace® as a tracer in SLN sampling in early stage EOC [ Time Frame: 2 years ]
    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


Secondary Outcome Measures :
  1. Comparison of detection rate between MagTrace® and 99mTc [ Time Frame: 2 years ]
    Between 1 primary staging laparotomy and 2 in secondary staging laparotomy

  2. Detection of potential adverse effects of MagTrace® and 99mTc [ Time Frame: 2 years ]
  3. Relationship between the observed SLN and the actual number of pathological lymphnodes [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Ovarian cancer is a female only disease
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05375526


Locations
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Netherlands
Maastricht UMC
Maastricht, Limburg, Netherlands, 6229 HX
Contact: Pim Laven, Drs.    0433867087    pim.laven@mumc.nl   
Contact: Sandrina Lambrechts, Dr.       sandrina.lambrechts@mumc.nl   
Sponsors and Collaborators
Maastricht University Medical Center
Universitaire Ziekenhuizen Leuven
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT05375526    
Other Study ID Numbers: NL75863.068.21
First Posted: May 16, 2022    Key Record Dates
Last Update Posted: May 16, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maastricht University Medical Center:
Sentinel lymph node
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Lymphatic Metastasis
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type