Recruiting

Sentinel Node BiopsySentinel Node Biopsy in Endometrial Cancer

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT01564264

Conditions

Uterine Neoplasms

Sentinel Lymph Node Biopsy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sentinel Lymph Node Biopsy

Study Details

Brief summary:

The purpose of this study is to determine if there is a difference between the lymphatic drainage of the cervix and corpus of the uterus after injecting a radiocolloid in the cervix and blue dye in the corpus of the uterus and to investigate the identification rate of sentinel nodes using this technique in patients with cancer of the uterus.

Conditions

Uterine Neoplasms

Sentinel Lymph Node Biopsy

Study ID

NCT01564264

Start date

Nov, 2012

Status verified date

Aug, 2014

Completion date

Dec, 2014

Anticipated

Primary completion date

Dec, 2014

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Women older than 18 years old
2. Endometrial cancer
3. Histologies: Grade 2 and 3 endometrioid adenocarcinoma, clear cell and papillary serous carcinoma
4. Suitable candidates for surgery
5. Clinically stage 1 or confined to the uterus

Exclusion Criteria:

1. Grade 1 endometrioid adenocarcinoma
2. Metastatic disease

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Sentinel Node Biopsy

Each participant will have both measurements, the new diagnostic test (sentinel node biopsy) and the gold standard (complete lymphadenectomy)

Interventions

Sentinel Lymph Node Biopsy

Sentinel node biopsy after injections of 0.4 mci of Technetium 99 in the cervix and 4 mL of Patent Blue into the myometrium followed by standard retroperitoneal lymph node dissection

Primary outcome measure

Location of Sentinel node [ Time Frame: Measurement for each participant will be performed between 2-4 hours after injecting Technetium 99 in the cervix ]

Central Contacts and Locations

Central contacts

Waldo G Jimenez, MD MSc

(905) 389-5688 Waldo.Jimenez@jcc.hhsc.ca

Laurie Elit, MD MSc

(905) 389-5688 Laurie.Elit@jcc.hhsc.ca

Locations

Juravinski Hospital, Juravinski Cancer Centre, McMaster University

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Contacts

Waldo G Jimenez, MD MSc

(905) 389-5688 Waldo.Jimenez@jcc.hhsc.ca

Laurie Elit, MD MSc

(905) 389-5688 Laurie.Elit@jcc.hhsc.ca

Principal Investigator:

Waldo G Jimenez, MD MSc

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Sep 3, 2014

Last verified

Aug, 2014

Keywords

Uterine Neoplasms
Sentinel Lymph Node Biopsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2014-09-03.