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Sentinel Node Detection in Ovarian Cancer

NCT02540551 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2020-03-24

No results posted yet for this study

Summary

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).

Conditions

  • Ovarian Neoplasms
  • Sentinel Node

Interventions

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.

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    collaborator OTHER

  • Radboud University Medical Center

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Roy Kruitwagen, MD, PhD · Maastricht University Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2019-07-01
Completion
2019-07-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02540551 on ClinicalTrials.gov