Sentinel Lymph Node Detection in Early Cervical Cancer
Sentinel Lymph Node Detection in Early Cervical Cancer
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.
Cancers of the cervix that are small and appear to be contained in the cervix (early stage)
 have up to 20 percent chance of having pelvic lymph nodes involved. The standard therapy is
 removal of the uterus and cervix (radical hysterectomy) and removal of all pelvic lymph nodes
 for all women with early stage cervical cancer. This procedure can be associated with
 significant intraoperative and postoperative complications including increased risk of damage
 to blood vessels and nerves in the pelvic region (leading to bladder, bowel and sexual
 dysfunction) as well as lymphedema (swelling, particularly in the legs) associated with
 significant pelvic lymph tissue removal.

 The objective of this study is to find a way to accurately identify the first lymph node that
 drains the tumour/cervix (SLN). If this SLN is correctly identified, and it's status
 (positive or negative for malignancy) is representative of the entire lymph node basin, a
 complete node dissection could be avoided. This could benefit many women with early stage
 cervical cancer, as a minority actually have evidence of disease in the nodes after surgery
 (between 5-20%) and limited lymph node sampling could prevent the associated complications of
 a full pelvic lymph node dissection.

 This is a prospective cohort study. The population to be studied is patients with newly
 diagnosed early stage cervical cancer undergoing primary surgical intervention including
 radical hysterectomy and bilateral pelvic lymphadenectomy. On the morning of surgery,
 preoperative injection of a radiolabeled colloid will be performed in the Nuclear Medicine
 Department followed by SPECT/CT to visualize the radiolabelled dye. Patients will then be
 taken to the operating room for their planned procedure. After initiation of general
 anesthesia, blue dye will be injected into the patient's cervix. The surgery will proceed and
 all lymph nodes that are "blue" and/or "hot" will be removed surgically, their anatomic
 location and laterality documented and sent for frozen section intraoperatively. The radical
 hysterectomy or radical trachelectomy and complete systematic bilateral pelvic
 lymphadenectomy will then be performed. The SLN status reported by the pathologist based on
 the frozen section will be compared to the status of the other nodes removed after complete
 lymphadenectomy and reported in the final pathology report (after formalin fixation and
 paraffin embedding). All data on these patients will be prospectively collected.

 This protocol will determine the feasibility of SLN mapping in women with early stage
 cervical cancer. The primary outcomes will be to measure the rate of detection of SLN using
 the combination of radiolabelled and blue dye (unilateral and bilateral detection rates will
 be reported) as well as the sensitivity and specificity of this technique, based on assessing
 how well the intraoperative reading of SLN frozen section corresponds with the final
 pathology lymph node status after examining all lymph nodes removed by complete pelvic
 lymphadenectomy.

 In addition, the investigators will assess the usefulness of preoperative SPECT/CT in
 identifying SLN and whether this modality accurately identifies the lymph node basin
 containing SLN compared to conventional lymphoscintigram.
Inclusion Criteria:

 1. Women with invasive adenocarcinoma or squamous cell carcinoma of the cervix

 2. Stages 1A1 (+LVSI), 1A2 and 1B1 (< 4 cm)

 3. If CT, MRI or PET have been performed preoperatively there must be no clear evidence
 of metastatic disease and/or parametrial involvement.

 4. Patients who have signed an approved informed consent.

 5. Patients who will undergo surgery that includes a radical hysterectomy and/or radical
 trachelectomy and bilateral lymphadenectomy via laparotomy, laparoscopy or
 robotic-assisted.

 Exclusion Criteria:

 1. Patients with known allergy to triphenylmethane compounds

 2. Pregnant patient

 3. Patients with previous retroperitoneal surgery

 4. Patients with previous history of pelvic/abdominal radiation

 5. Patients with recurrent cervical cancer

 6. Any patient treated with neoadjuvant chemotherapy and/or radiation