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

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Brief Title

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

Official Title

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

Brief 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.
    

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


Primary Outcome

Sensitivity, predictive value, anatomic localization, and impact on management of SPECT/CT guided LM/SL versus CLND

Secondary Outcome

 Patient tolerability and operating time for SPECT/CT guided LM/SL versus CLND

Condition

Cervical Cancer

Intervention

SPECT/CT guided LM/SL

Study Arms / Comparison Groups

 A
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

15

Start Date

April 2008

Completion Date

February 2012

Primary Completion Date

February 2012

Eligibility Criteria

        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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Irina Rachinsky, MD, MSc, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00773071

Organization ID

R-06-377

Secondary IDs

12576

Responsible Party

Principal Investigator

Study Sponsor

Lawson Health Research Institute

Collaborators

 University of Western Ontario, Canada

Study Sponsor

Irina Rachinsky, MD, MSc, Principal Investigator, The University of Western Ontario - Nuclear Medicine


Verification Date

June 2012