NCT03900104

Brief Summary

The investigators think that trans-cervical endometrial tracer injection will cause more paraaortic sentinel lymph node detection. Also, this application is easy, cost-effective and safer than hysteroscopic method. Transtubal tumor spearing will not occur with this method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

March 31, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
29 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

8 months

First QC Date

March 31, 2019

Last Update Submit

February 18, 2020

Conditions

Endometrial CancerSentinel Lymph Node

Keywords

Endometrial CancerSentinel Lymph NodeParaaortic nodes involvement

Outcome Measures

Primary Outcomes (1)

  • Detected pelvic and paraaortic sentinel lymph node numbers

    Detected pelvic and paraaortic sentinel lymph node numbers in pathological examination (Ultrastaging)

    Postoperative 30 days

Secondary Outcomes (1)

  • Numbers adverse events

    Postoperative 90 days

Study Arms (2)

Transcervical endometrial injection arm

EXPERIMENTAL

Tracer injection performed by a transcervical catheter in endometrial cancer patients.

Procedure: Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles

Cervical injection arm

ACTIVE COMPARATOR

Tracer injection was administered via the cervical route in endometrial cancer patients.

Procedure: Cervical injection of technetium 99 m-labeled human albumin colloid particles

Interventions

Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particlesPROCEDURE

Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles, in 5 mL saline, 2 hours before surgery. Injection performed with a trans-cervical catheter

Transcervical endometrial injection arm
Cervical injection of technetium 99 m-labeled human albumin colloid particlesPROCEDURE

Cervical injection of technetium 99 m-labeled human albumin colloid particles, in 5 mL saline, 2 hours before surgery.

Cervical injection arm

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Endometrial Cancer Patients
  • Suitable patients for surgical staging

You may not qualify if:

  • Patients who cannot undergo cervical or transcervical endometrial injection
  • Pathology did not confirm endometrial cancer
  • Sarcoma of the uterine corpus
  • If a 90-day follow-up was not feasible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, 41380, Turkey (Türkiye)

Location

Related Publications (2)

  • Solima E, Martinelli F, Ditto A, Maccauro M, Carcangiu M, Mariani L, Kusamura S, Fontanelli R, Grijuela B, Raspagliesi F. Diagnostic accuracy of sentinel node in endometrial cancer by using hysteroscopic injection of radiolabeled tracer. Gynecol Oncol. 2012 Sep;126(3):419-23. doi: 10.1016/j.ygyno.2012.05.025. Epub 2012 May 30.

    PMID: 22659192BACKGROUND

  • Niikura H, Kaiho-Sakuma M, Tokunaga H, Toyoshima M, Utsunomiya H, Nagase S, Takano T, Watanabe M, Ito K, Yaegashi N. Tracer injection sites and combinations for sentinel lymph node detection in patients with endometrial cancer. Gynecol Oncol. 2013 Nov;131(2):299-303. doi: 10.1016/j.ygyno.2013.08.018. Epub 2013 Aug 27.

    PMID: 23988415BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Şener Gezer, M.D

    Kocaeli University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 31, 2019

First Posted

April 2, 2019

Study Start

May 1, 2019

Primary Completion

January 1, 2020

Study Completion

January 15, 2020

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)