Added-value of SPECT/CT in Patients Undergoing LM/SL for Gynecological Cancers

June 7, 2012 updated by: Irina Rachinsky, Lawson Health Research Institute

Added-value of SPECT/CT in Patients Undergoing Lymphatic Mapping and Sentinel Lymphadenectomy (LM/SL) for Gynecological Cancers

Nodal staging is a key-step in pre-treatment assessment of gynecological cancers. In recent years, lymphatic mapping and sentinel lymphadenectomy (LM/SL) as a minimally invasive pelvic lymph nodes staging has been successfully evaluated in women with early stage of vulvar cancer, cervical cancer, and endometrial cancer. Such a technique may offer several valuable advantages: a) it is readily applicable in clinical routine using a safe, inexpensive, and reproducible protocol; b) it may help to avoid the cost and the morbidity of unnecessary lymphadenectomy in the majority of cases with uninvolved sentinel lymph nodes; c) it has the potential to guide the surgeon to nodal regions that are not routinely dissected (i.e. pre-sacral, para-aortic nodes) and to identify micro-metastases that would have been ignored otherwise; d) it also offers the basis for sophisticated pathological analysis to detect sub-microscopic nodal metastases using either immunohistochemical or molecular biological techniques.

So far, within the abdomen and the pelvis, the LM/SL technique alone is often blinded to the accurate localization of SLNs. The integration of computed tomography (CT) to single photon emission computed tomography (SPECT) devices in a single gantry (SPECT/CT) has allowed a significant gain in terms of diagnostic accuracy and anatomic precision; clinical examples include malignant melanoma, head and neck cancer, breast cancer, and bladder cancer. In a seminal series of 26 patients with cervical cancer (Zhang et al., 2006), SPECT/CT was recently found superior to conventional planar imaging for detection of SLN and accurate localization. A more recent study (Kushner al., 2007) has also highlighted the technical feasibility and the clinical added-value of a low-dose SPECT/CT in a series of 20 patients with early stage cervical cancer (IA2-IIA) who underwent LM/SL.

In the light of the encouraging data from literature and our own preliminary clinical experience, we hypothesized that the use of LM/SL plus SPECT/CT may be of clinical interest in patients with gynecological cancers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This clinical trial is aimed at assessing the utility of a minimally invasive surgery preoperatively guided by a new nuclear medicine imaging procedure called SPECT/CT. In patients suffering from an early stage of gynecological cancer with no clinical evidence of lymph node involvement, there is theoretically no reason to perform systematically an aggressive lymphadenectomy as demonstrated for other types of lymphophilic cancers such as malignant melanoma, breast cancer, and head and neck cancer.

We plan to follow a well known and safe procedure in Nuclear Medicine called lymphatic mapping and sentinel lymphadenectomy (LM/SL). The patient will be injected by the gynecologist referee in the department of Nuclear Medicine. These injections consist of a radioactive tracer routinely used in Nuclear Medicine, which allows the detection of the first nodes draining the primary tumor. The so-called sentinel lymph node (SLN) may be different from the lymph nodes anatomically predefined. As well demonstrated for other cancers, including those mentioned above, we hypothesized that the histological status of the SLN may accurately reflect the histological status of the entire nodal basin. If this assumption is clinically validated, the minimally invasive procedure may avoid the cost and the morbidity of unnecessary complete lymph node dissections in the majority of patients with uninvolved SLNs.

The originality of this clinical trial also relies upon the use of a new hybrid imaging device called SPECT/CT, which allows the ability to obtain in a single study both functional and anatomical information. This is critical to precisely guide the surgeon in his task. No contrast medium will be injected during this study. The radiation exposure remains within the limits accepted worldwide; for instance, the CT dose index (CTDI) will be 3.0 mGy, which is in the order of the yearly natural background radiation exposure (< 2mSv).

In this clinical trial, all patients will be treated according to the standard of care currently applied for gynecological cancers. Therefore, either the hysterectomy or the vulvectomy will be followed by a complete lymph node dissection (CLND).

Overall, the research protocol will be carried out in a 1-day protocol including the SPECT/CT guided LM/SL and the CLND.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A4G5
        • 375, South Street Hospital - Dpt. of Nuclear Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with histologically proven gynecological cancers
  • Patients with FIGO IA2 and IB1 cervical cancers
  • Cervical cancer patients will be scheduled for radical hysterectomy and pelvic lymph node dissection
  • Patients with FIGO IB and II vulvar cancers and those of patients with FIGO III with clinically negative regional lymph nodes
  • Vulvar cancer patients will be scheduled for vulvectomy and inguinal lymph node dissection
  • Informed consent signed by the patient, the gynaecologist, and the nuclear medicine physician referees

Exclusion Criteria:

  • Patients with no histological evidence of gynecological cancer
  • Patient with regionally advanced disease or metastatic disease
  • Patients with clinically and/or radiologically evident regional lymph node metastases
  • Patients who are not scheduled for radical surgery and lymph node dissection
  • Patients with physical and/or psychological contraindications
  • Recent study in Nuclear Medicine with long half-time isotopes (i.e. T ½ >48h; 111In, 67Ga, 201Tl, 131I ) performed within 1 week preceding the LM/SL
  • Pregnant or lactating patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A

Single photon emission computed tomography/computed tomography (SPECT/CT) guided lymphatic mapping and sentinel lymphadenectomy (LM/SL) vs. complete lymph node dissection (CLND)

All cervical cancer and vulvar cancer patients will undergo CLND according to the standard of care in gynecologic cancers as recommended by the International Federation of Gynecology and Obstetrics (FIGO).

Patients with FIGO IA2 and IB1 cervical cancers will be scheduled for radical hysterectomy and pelvic lymph node dissection.

Patients with FIGO IB and II vulvar cancers and those of patients with FIGO III with clinically negative regional lymph nodes will be scheduled for vulvectomy and inguinal lymph node dissection.
Device: SPECT/CT guided LM/SL
Pre-operatively, SLNs will be detected by low-dose SPECT/CT (99mTc-cystein rhenium colloids, 1cc/1mCi). Intra-operatively, a blue-dye (Patent Blue, 2cc) and a gamma-probe guidance will be used to detect the SLN nodes. All blue-stained and/or hot lymph nodes with a radioactivity greater than 10% of the hottest node will be considered as SLNs. Serial sections of SLNs will be analyzed by H-E staining. In cases of negative H-E, the SLNs will be further analyzed by immunochemistry (CKAE1/CKAE3, and high molecular weight Cytokeratin 34BE12). Non-SLNs will be analyzed as usual in routine by H-E.
Other Names:
  • Sentinel lymph node detection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity, predictive value, anatomic localization, and impact on management of SPECT/CT guided LM/SL versus CLND
Time Frame: 6 months -1 year
6 months -1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient tolerability and operating time for SPECT/CT guided LM/SL versus CLND
Time Frame: 6 months - 1 year
6 months - 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

University of Western Ontario, Canada

Investigators

  • Principal Investigator: Irina Rachinsky, MD, MSc, The University of Western Ontario - Nuclear Medicine
  • Study Chair: Jean-Luc Urbain, MD, PhD, The University of Western Ontario - Nuclear Medicine
  • Study Director: Monique Bertrand, MD, PhD, The University of Western ontario - Gynaecology
  • Study Director: Helen Ettler, MD, The University of Western Ontario -Pathology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

July 25, 2008

First Submitted That Met QC Criteria

October 15, 2008

First Posted (Estimate)

October 16, 2008

Study Record Updates

Last Update Posted (Estimate)

June 8, 2012

Last Update Submitted That Met QC Criteria

June 7, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-06-377
  • 12576 (Registry Identifier: UWO Research Ethics Board number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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