Sentinel Node Detection in Ovarian Cancer

NCT02540551 | Terminated Phase 1

• 1 other identifier: METC152028
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of patients (%) in which sentinel node(s) are detected after injection of blue dye and tracer in the ovarian ligaments.

  During the surgical procedure

Secondary Outcomes (1)

• Number of blue colorized sentinel nodes (%) 15, 30, 45, and 60 minutes after injection.

  During the surgical procedure

Study Arms (1)

Sentinel node procedure.

EXPERIMENTAL

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

Interventions

Injection of radioactive tracer combined with Patent Blue PROCEDURE

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.

Also known as: Nanocoll, Patent Blue

Sentinel node procedure.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• The Netherlands Cancer Institute: collaborator
• Radboud University Medical Center: collaborator

Study Sites (1)

Maastricht UMC, Dept. Obst&Gyn

Maastricht, Netherlands

Location

Related Publications (2)

• Kleppe M, Brans B, Van Gorp T, Slangen BF, Kruse AJ, Pooters IN, Lotz MG, Van de Vijver KK, Kruitwagen RF. The detection of sentinel nodes in ovarian cancer: a feasibility study. J Nucl Med. 2014 Nov;55(11):1799-804. doi: 10.2967/jnumed.114.144329. Epub 2014 Oct 20.

  PMID: 25332439 RESULT

• Laven P, Kruitwagen R, Zusterzeel P, Slangen B, van Gorp T, van der Pol J, Lambrechts S. Sentinel lymph node identification in early stage ovarian cancer: is it still possible after prior tumor resection? J Ovarian Res. 2021 Oct 13;14(1):132. doi: 10.1186/s13048-021-00887-w.

  PMID: 34645514 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

technetium Tc 99m nanocolloid; sulfan blue

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

Study Officials

• Roy Kruitwagen, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: September 4, 2015
• Study Start: January 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: March 24, 2020

Record last verified: 2020-03

Locations

NL (1)