Sentinel Node Detection in Ovarian Cancer (SONAR-2)

March 21, 2020 updated by: Maastricht University Medical Center

Sentinel Node in Ovarian Cancer: SONAR-2

Recently the investigators have shown that the SN procedure performed through the injection of tracers into the ovarian ligaments is feasible and promising in patients with clinical early stage ovarian cancer (OC). Injection of radioactive tracers resulted in the identification of SNs in all 21 patients. Before a multicentre prospective trial can be initiated, still some questions have to be answered, especially if a SN procedure still is feasable in patients with OC through injection of the tracers in the ovarian ligaments, when the ovarian tumour has already been resected, either during the same surgical procedure (ovarian tumour resected for frozen section with a malignancy as result) or at a second surgical procedure to complete the staging procedure (by laparotomy or laparoscopy).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Rationale:

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 SN does not contain cancer, then 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 SN technique has been proven to be effective in other cancers such as breast cancer and malignant melanoma. In the gynaecological field it has been shown to be effective in vulvar cancer. Recently the investigators have shown that the SN procedure performed through the injection of tracers into the ovarian ligaments is feasible and promising in patients with clinical early stage ovarian cancer (OC). Injection of radioactive tracers resulted in the identification of SNs in all 21 patients. Before a multicentre prospective trial can be initiated, still some questions have to be answered.

Objectives:

  1. To determine whether or not a SN procedure in patients with OC is feasible through injection of the tracers in the ovarian ligaments, when the ovarian tumour has already been resected

    1. during the same surgical procedure (ovarian tumour resected for frozen section with a malignancy as result)
    2. during a second surgical procedure to complete the staging procedure (by laparotomy or laparoscopy), which becomes actual when a previously resected apparently benign ovarian tumour appears to be malignant at definite pathology.
  2. To determine if blue colorization of the sentinel nodes after injection of blue dye is related to the time-interval between injection and retroperitoneal exploration?
  3. To determine if the technique becomes more accurate by using a mobile gamma-camera guidance during the surgical procedure.

Study design: phase I feasibility study.

Study population: the following patients will be included:

  • Patients with a high suspicion of an ovarian malignancy in whom a median laparotomy and a frozen section analysis is planned.
  • Patients in whom previously an adnexal mass has been removed which appeared to be malignant, in whom a surgical staging procedure is planned.

Intervention (if applicable): Injection of blue dye and the radioactive-colloid in the ligamentum ovarium proprium and the ligamentum infundibulo-pelvicum. This will be done on the side of (suspected) malignancy.

Main study parameter:

Percentage of patients in whom it is feasible to identify SN's in case the malignant ovarian mass has already been resected.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: in case the tracer is injected with the adnexal mass still in situ, the surgery is prolonged at maximum with 20-25 minutes due to the required incubation time after injection of the blue dye and radioactive isotope. A scintigram will be performed 24 hours after the surgery to determine whether residual radioactive lymph nodes can be detected. The scintigram will only be performed if the patient is capable to be transported to the nuclear department. No extra blood samples will be taken, no extra visits, physical examinations or other tests are necessary. There is no risk of tumour dissemination by injecting the tracers in the ovarian ligaments. There is a 0.07 to 2.7% risk of an allergic reaction to the blue dye. The dose of radioactive isotope given does not give adverse side effects, either to the patients or the personnel present in the operating theatre.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 1

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
      • Maastricht, Netherlands
        • Maastricht UMC, Dept. Obst&Gyn

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 to 85 years (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. Only when a malignancy is confirmed by frozen section, the SNs will be removed prior to proceeding with a complete staging procedure.
  • Patients in whom the ovarian malignant tumour has already been resected and a second surgical procedure is planned to complete the staging procedure including lymph nodes.
  • Mentally competent to give informed consent.

Exclusion Criteria:

  • 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: Sentinel node procedure.
Intervention: injection of blue dye and radioactive tracer (99mTc-nanocolloid or Nanocoll) in remains of the ovarian ligaments.
Procedure: Injection of radioactive tracer combined with Patent Blue
Blue dye and the radioactive isotope will be injected in the remains of the ligamentum ovarium proprium (median side) and the ligamentum infundibulo-pelvicum (lateral side), just below the peritoneum. Four syringes containing 0,2 ml patent blue and 0,15 ml (20-MBq) radioactive isotope (99mTc-nanocolloid or Nanocoll®, GE Healthcare, Eindhoven, The Netherlands) will be given. After a 15-minute interval the radioactivity the SN(s) will be identified either by the mobile gamma-camera and /or gamma-probe and / or visually (blue dye) after opening the retroperitoneal space.
Other Names:
  • Nanocoll
  • Patent Blue

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 the surgical procedure
During the surgical procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of blue colorized sentinel nodes (%) 15, 30, 45, and 60 minutes after injection.
Time Frame: During the surgical procedure
In the investigator's initial feasibility study in which the tracers were injected into the ligaments of the ovary, in only 2 out of 6 patients blue-stained SNs were detected after retroperitoneal exploration. The long interval between the injection of Blue Patent and retroperitoneal exploration of at least 50 min in this study may have caused the blue dye to fade before the surgical procedure.
During the surgical procedure

Collaborators and Investigators

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

Sponsor

Maastricht University Medical Center

Collaborators

Radboud University Medical Center
The Netherlands Cancer Institute

Investigators

  • Principal Investigator: Roy Kruitwagen, MD, PhD, Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 1, 2016

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

August 7, 2015

First Submitted That Met QC Criteria

September 1, 2015

First Posted (Estimate)

September 4, 2015

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 21, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METC152028

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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