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

Summary

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.

Conditions

• Cervical Cancer
• Vulvar Cancer

Interventions

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.

Sponsors & Collaborators

• University of Western Ontario, Canada

  collaborator OTHER

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  lead OTHER

Principal Investigators

• Irina Rachinsky, MD, MSc · The University of Western Ontario - Nuclear Medicine

• Jean-Luc Urbain, MD, PhD · The University of Western Ontario - Nuclear Medicine

• Monique Bertrand, MD, PhD · The University of Western ontario - Gynaecology

• Helen Ettler, MD · The University of Western Ontario -Pathology

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-04-30

Primary Completion

2012-02-29

Completion

2012-02-29

Countries

• Canada

Study Locations