Sentinel Node Detection in Clinical Early Stage Ovarian Cancer (SONAR)

April 4, 2018 updated by: Maastricht University Medical Center

As most cancers, ovarian cancer also spreads to regional lymph nodes. The concept of sentinel lymph node surgery is to see whether the cancer has spread to the very first lymph node or sentinel node (SN). If the sentinel node does not contain cancer, there is a high likelihood that the cancer has not spread to other lymph nodes. This means that, at least theoretically, a radical lymphadenectomy could be omitted and thus the associated morbidity. The sentinel node technique has been proven to be effective in different cancers such as breast cancer and malignant melanoma. In gynaecological tumors it has been shown to be effective in vulvar cancer. Currently sentinel node studies are done for cervix and uterine cancer.

The present study determines whether or not a sentinel node procedure in patients with ovarian cancer is feasible when the tracers are injected in the ovarian ligaments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

According to the International Federation of Gynecology and Obstetrics (FIGO), Epithelial Ovarian Cancer (EOC) with lymph node metastases is classified as FIGO stage IIIC disease, even in the absence of peritoneal metastases. In contrast to patients with FIGO stage I ovarian cancer after a comprehensive staging procedure, patients with a FIGO stage III ovarian cancer obtain adjuvant chemotherapy. Therefore, the recognition of lymph node metastases is of utmost importance. In general, the incidence of lymph node metastases in clinical early stage EOC is approximately 14%, and depends on subtype histology (i.e. serous 23%, mucinous 3%) and differentiation grade (4% and 20% in grade 1 and 3 tumors respectively).

Surgical staging of EOC and the extent of lymph node dissection differs greatly from centre to centre. In case of a clinical early stage ovarian cancer, the Dutch guideline recommends a staging laparotomy with adequate lymph node sampling, with an absolute minimum of ten lymph nodes removed. In the same guideline, a footnote is made stating that a larger number of removed lymph nodes will increase the chance of finding metastases. These lymph nodes also need to be sampled from different anatomical regions, of which the most important are the para-aortic and paracaval region between the renal vein and inferior mesenteric artery, the common, internal and external iliac vessels and the obturator fossa.

A systematic lymphadenectomy can be seen as the golden standard. However, such a radical procedure gives more late morbidity than lymph node sampling. These include the formation of lymphocyst (up to 13.5%), nerve and vessel injury (up to 4%), and increased blood loss and operating time [26, 27]. Studies done for sentinel node in ovarian cancer are very limited and performed in women with uterine cancer by injecting the tracers in the ovary. In case of ovarian cancer such a procedure gives a possible risk of tumour dissemination. In this feasibility study the tracers are injected in the ligaments of the ovary, not in the cortex itself.

Patients with (suspicion of) ovarian cancer as well as patients with a high-grade uterine carcinoma will be included. The latter group of patients can also be included because these patients undergo the same surgical procedure; Total Abdominal Hysterectomy (TAH) with Bilateral Salpingo-Oophorectomy (BSO) and a pelvic and para-aortic lymphadenectomy or lymph node sampling.

Both blue dye and the radioactive isotope will be injected in the ligamentum ovarii proprium (median side) and the ligamentum infundibulo-pelvicum (lateral side), close to the ovary and just below the peritoneum.

In case of an ovarian tumor: after 15 minutes time-interval the ovarian mass will be removed and presented to the pathologist for a frozen section. If the result is benign, no further actions will be performed in these patients. If the result is malignant, the sentinel node(s) will be identified either by the radioactive tracer and / or visually (blue dye) after opening the retroperitoneal space. After removal of the sentinel node(s) a complete standard staging procedure will be performed including a comprehensive sampling of other lymph nodes at the different locations.

In case of endometrial cancer: after 15 minutes time-interval the surgical staging procedure starts with a TAH and BSO. After approximately 45 minutes the sentinel node(s) will be identified either by the radioactive tracer and / or visually (blue dye) after opening the retroperitoneal space. This 45 minutes time-interval is chosen to mimic the time interval when a frozen section is performed in case of an ovarian tumor. After removal of the sentinel node(s) a complete standard staging procedure will be performed including a comprehensive at random sampling of other lymph nodes at the different locations.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6202 AZ
        • MaastrichtUMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with a high suspicion of a malignant ovarian tumour planned for exploratory laparotomy.
  • Patients with high-risk endometrial cancer in whom a staging laparotomy is planned.
  • Age between 18 and 85 years.

Exclusion Criteria:

  • Previous surgery of both ovaries.
  • Previous vascular surgery of the aorta, caval vein, and/or iliac vessels.
  • Previous lymphadenectomy of lymph node sampling in the iliac or para-aortal region.
  • History of a malignant lymphoma.
  • History of a malignant tumour in the abdominal cavity.
  • Previous allergic reaction to blue dye.
  • Pregnant or lactating patients.
  • An allergy for human albumin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tracerinjection
The intervention concerns tracerinjection (both blue dye and the radioactive isotope beingtechnetium-99-m-labeled albumin nanocolloid) in the ligamentum ovarii proprium (median side) and the ligamentum infundibulo-pelvicum (lateral side), close to the ovary and just below the peritoneum.
Procedure: Tracerinjection
The intervention concerns the tracerinjection for detection of the sentinel node.
Other Names:
  • 99mTc-nanocolloid or Nanocoll

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Patients (%) in Which Sentinel Node(s) Are Detected After Injection of Blue Dye and Tracer in the Ovarian Ligaments.
Time Frame: During surgery.
During surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anatomical Location(s) of the Sentinel Nodes.
Time Frame: During surgery.
The number of patients with only paraaortic/paracaval, only pelvic, and both paraaortic/paracaval and pelvic sentinel node locations.patients.
During surgery.

Other Outcome Measures

Outcome Measure
Time Frame
Number of Patients With False Negative Sentinel Nodes.
Time Frame: During surgery.
During surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Study Director: Roy Kruitwagen, MD, PhD, Maastricht UMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

October 31, 2012

First Submitted That Met QC Criteria

November 21, 2012

First Posted (Estimate)

November 28, 2012

Study Record Updates

Last Update Posted (Actual)

November 5, 2018

Last Update Submitted That Met QC Criteria

April 4, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL40323.068.12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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