NCT01734746

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable ovarian-cancer

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2012

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 28, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

November 5, 2018

Completed
Last Updated

November 5, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

October 31, 2012

Results QC Date

July 29, 2015

Last Update Submit

April 4, 2018

Conditions

Ovarian CancerSentinel Node

Keywords

ovarian cancersentinel 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 surgery.

Secondary Outcomes (1)

  • Anatomical Location(s) of the Sentinel Nodes.

    During surgery.

Other Outcomes (1)

  • Number of Patients With False Negative Sentinel Nodes.

    During surgery.

Study Arms (1)

Tracerinjection

EXPERIMENTAL

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

Interventions

TracerinjectionPROCEDURE

The intervention concerns the tracerinjection for detection of the sentinel node.

Also known as: 99mTc-nanocolloid or Nanocoll
Tracerinjection

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MaastrichtUMC

Maastricht, Limburg, 6202 AZ, Netherlands

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

technetium Tc 99m nanocolloid

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Results Point of Contact

Title
R.F.P.M. Kruitwagen
Organization
MaastrichtUMC
r.kruitwagen@mumc.nl
+31433874767

Study Officials

  • Roy Kruitwagen, MD, PhD

    Maastricht UMC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2012

First Posted

November 28, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

November 5, 2018

Results First Posted

November 5, 2018

Record last verified: 2018-04

Locations

NL(1)