The Value of Preoperative Sentinel Lymph Node Mapping by Pelvic MR Lymphangiography and SPECT-CT in Cervical Cancer

Objective of the study: To study the concordance of sentinel node (SN) localization between preoperative Magnetic Resonance Lymphangiography and SPECT-CT SN mapping and the intra-operative SN procedure for low stage cervical cancer. Background: The SN procedure for surgically treated cervical cancer is promising. Unfortunately, efficient and direct intra-operative SN localisation, without an extensive surgical exploration, remains a challenge even with combined use of patent blue dye en technetium-99m (99mTc). Preoperative imaging (= mapping) with 99mTc based SPECT-CT, which is increasingly adopted, has partly alleviated this problem. The investigators aim to investigate the feasibility of a new SN mapping modality, which visualises the (sentinel) lymph nodes using a Magnetic Resonance Imaging (MRI) technique (so called; Magnetic Resonance Lymphangiography), and compare it to SPECT-CT. Design: Prospective, feasibility type diagnostic study. 40 subjects targeted. Via vaginal speculum exam, a specific MRI contrast-agent will be intracervically injected. Subsequently, on a wide bore 1.5T MRI system multiplanar imaging is performed, followed by a blinded review (experienced radiologist) for bilateral SN localization. Standard care with a preoperative SPECT-CT (after intracervical 99mTc administration). A blinded nuclear medicine specialist will localize the SN on the SPECT-CT images. Open or (robot-assisted) laparoscopy performed for localization of the blue stained and/or 99mTc-hot SN. Excision of the SN with freeze sectioning and histological review. Statistical analysis with intrapatient testing for concordance of MR Lympangiography and SPECT-CT based SN localization against the reference standard: the intra-operative sentinel node procedure.

Sex

Female

Minimum age

18 Years

Inclusion Criteria:

1. Histologically proven primary malignancy of the cervix uteri;
2. Primary therapy is surgery with minimally an intra-operative SN procedure and pelvic lymph node dissection;
3. ≥18 years of age and written inform consent provided.

Exclusion Criteria:

1. Contra-indications to MR lymphangiography, defined as:

   * All MRI incompatible electronic and/or ferromagnetic objects;
   * Presence of any object in the pelvic area prohibiting good image quality;
   * Severe claustrophobia;
   * Pregnancy or breastfeeding;
   * Unable to lie still and in complete supine position for 45 minutes;
   * Body weight \>150kg;
   * History of an allergic reaction to any gadolinium based contrast agent;
   * Renal disease with a glomerular filtration rate (GFR) ≤ 30 mL/min/1.73m2;
2. History of an allergic reaction to patent blue V dye;
3. Any type of neo-adjuvant chemo and/or radiotherapy for cervical cancer;
4. Altered anatomy of pelvic lymph nodal drainage system (e.g. history of retroperitoneal pelvic surgery or trauma).