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

18 Years
Not Enrolling
Cervical Cancer

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Trial Information

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

Background of the study: The sentinel procedure (SN) for surgically treated cervical cancer
is promising. Unfortunately, efficient and direct intra-operative SN localisation, without
an extensive retroperitoneal exploration, remains a challenge even with combined use of
patent blue dye en 99mTc. The draining lymph nodes are positioned around the retroperitoneal
pelvic vasculature, in close relation to the ureters and nerves innervating bladder, rectum
and sexual functionality (inferior hypogastric plexus, genitofemoral nerve, etc), which
makes exploration hazardous and time consuming. Furthermore, complete retroperitoneal
exploration often necessitates dissection of lymph vessels (to find the SN) which would have
been spared in a selective SN excision. The use of technetium-99m(99mTc) enables
preoperative SN mapping with SPECT(-CT) to localise SN and partly alleviate this issue. Some
clinics perform preoperative SPECT(-CT), despite its disadvantages of prolonged hospital
admission, radiation exposure, limited spatial resolution (SPECT) and the limited soft
tissue differentiation in the female pelvis (CT). The investigators postulate that Magnetic
Resonance (MR) Lymphangiography is a better technique for preoperative SN mapping in
cervical cancer. It allows for integration with regular work-up pelvic MRI and could make
SPECT-CT unnecessary.

Objective of the study: To study the concordance of sentinel node localization between
preoperative MR Lymphangiography and SPECT-CT SN mapping and the intra-operative sentinel
node procedure (patent blue and 99mTc) for low stage cervical cancer.

Study design: Prospective, feasibility type diagnostic study with the experimental test (MR
Lymphangiography) added to standard clinical care (SPECT-CT, intra-operative SN procedure).

Methods: 40 subjects targeted. Via a vaginal speculum exam 1ml of MR contrastmedium will be
intracervically injected peripheral of the cervical tumor at 3, 6, 9 and 12 o'clock (suspine
position). On a wide bore digital 1.5T MRI multiplanar T1w imaging is performed, followed by
a blinded review (experienced radiologist) for bilateral SN localization with a standardized
anatomical system. Standard procedure with a preoperative 220 MBq 99mTc SPECT-CT, a blinded
nuclear medicine specialist will localize the SN. Standard peri-operative care; under
general anesthesia 1ml injection of patent blue V in each of the four quadrants. Open or
(robot-assisted) laparoscopy performed for visual localization of the blue SN's.
Introduction of a gamma-probe and localization 'hot and blue' SN. For both methods
anatomical locations of the SN are registered. Excision SN for freeze sectioning and
histological review. Statistical analysis with intrapatient testing for concordance of
SPECT-CT and MR Lympangiography based SN localization against the reference standard: the
intra-operative sentinel node procedure (Patent blue and 99mTc).

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).

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Level of concordance in sentinel node (SN) localization between Magnetic Resonance Lymphangiography and SPECT-CT SN mapping with the intra-operative SN detection (based on blue dye and Tc-99m-nanocolloid).

Outcome Time Frame:

within 1 week

Safety Issue:


Principal Investigator

Ronald Zweemer, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UMC Utrecht


Netherlands: Dutch Health Care Inspectorate

Study ID:




Start Date:

April 2013

Completion Date:

April 2016

Related Keywords:

  • Cervical Cancer
  • Uterine Cervical Neoplasms