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

18 Years
Not Enrolling
Cervical Cancer, Vulvar Cancer

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Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Time Frame:

6 months -1 year

Safety Issue:


Principal Investigator

Irina Rachinsky, MD, MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Western Ontario - Nuclear Medicine


Canada: Ethics Review Committee

Study ID:




Start Date:

April 2008

Completion Date:

February 2012

Related Keywords:

  • Cervical Cancer
  • Vulvar Cancer
  • Cervical cancer, vulvar cancer, LM/SL, SPECT/CT
  • Uterine Cervical Neoplasms
  • Vulvar Neoplasms