Sentinel Lymph Node Detection in Early Cervical Cancer

NCT02543775 | Completed DMC

• 1 other identifier: 09-1003-CE
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to determine the feasibility of detecting the sentinel lymph node (SLN) in patients with early invasive cervical cancer using a combined radioisotope and blue dye technique. The investigators hypothesize that the sentinel lymph node (first node draining the tumour/cervix) for early stage cervical cancer represents the status of the regional lymph node basin (pelvic lymph nodes) and identification of a negative SLN would negate the need for complete pelvic lymphadenectomy.

Conditions

Cervical Cancer

Keywords

Cervical Cancer; Sentinel Lymph Node; Lymphadenectomy

Outcome Measures

Primary Outcomes (1)

• Sensitivity of sentinel lymph node (SLN) detection in patients with early invasive cervical cancer using a combined radioisotope and blue dye technique.

  Three years

Secondary Outcomes (1)

• SLN status correspondence with the overall pelvic lymph node positivity (specificity) as determined by lymphadenectomy (gold standard).

  Three years

Study Arms (1)

Sentinel lymph node mapping

EXPERIMENTAL

Patients who consent to the study will have preoperative and intraoperative SLN mapping performed. This will include injection of a radioisotope (Technetium 99) into the cervix and imaging (SPECT/CT) at Nuclear Medicine in the morning prior to surgery in an effort to identify the lymph node basin containing the sentinel nodes. Intraoperatively, blue dye will also be injected into the cervix to aid in location of the sentinel nodes.

Procedure: Preoperative and intraoperative SLN Mapping

Interventions

Preoperative and intraoperative SLN Mapping PROCEDURE

Patients will undergo preoperative SLN mapping, which includes an injection of a radiocolloid and lymphosinctogram and SPECT/CT. Patients will also receive an intraoperative injection of blue dye. A handheld probe will be utilized to detect radiolabelled or "hot" nodes and direct visualization will identify blue nodes which will be labelled "Sentinel Nodes" and sent to pathology for intraoperative frozen section.

Sentinel lymph node mapping

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with invasive adenocarcinoma or squamous cell carcinoma of the cervix
• Stages 1A1 (+LVSI), 1A2 and 1B1 (\< 4 cm)
• If CT, MRI or PET have been performed preoperatively there must be no clear evidence of metastatic disease and/or parametrial involvement.
• Patients who have signed an approved informed consent.
• Patients who will undergo surgery that includes a radical hysterectomy and/or radical trachelectomy and bilateral lymphadenectomy via laparotomy, laparoscopy or robotic-assisted.

You may not qualify if:

• Patients with known allergy to triphenylmethane compounds
• Pregnant patient
• Patients with previous retroperitoneal surgery
• Patients with previous history of pelvic/abdominal radiation
• Patients with recurrent cervical cancer
• Any patient treated with neoadjuvant chemotherapy and/or radiation

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Princess Margaret Hospital, Canada: collaborator

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G2M9, Canada

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Sarah Ferguson, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

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: June 2, 2015
• First Posted: September 7, 2015
• Study Start: July 1, 2010
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: June 18, 2019

Record last verified: 2019-06

Locations

CA (1)