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The Value of Preoperative Sentinel Lymph Node Mapping by Pelvic MR Lymphangiography and SPECT-CT in Cervical Cancer
1 other identifier
observational
N/A
1 country
1
Brief Summary
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.
Trial Health
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Started Apr 2013
Typical duration for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2013
CompletedFirst Posted
Study publicly available on registry
January 28, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedDecember 18, 2014
December 1, 2014
3 years
January 17, 2013
December 17, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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).
within 1 week
Secondary Outcomes (3)
The absolute number of SN detected and uni/bilateral SN detection rates by MR lymphangiography, SPECT-CT, intra-operative SN procedure with patent blue only and combined patent blue / 99mTc.
within 1 week
The false negative rates in SN localization by MR lymphangiography, SPECT-CT, intra-operative SN procedure with patent blue only and combined patent blue / 99mTc.
within 1 week
Disagreement between the; concordance SN localization SPECT-CT and intra-operative SN procedure (blue + 99mTc) with the concordance MR lymphangiography and intra-operative blue dye only SN procedure (strategy without 99mTc).
within 1 week
Study Arms (1)
All patients
Alle subjects included retain in one cohort.
Interventions
sentinel node localisation using the nuclear medicine technique SPECT-CT
Sentinel node localisation using Magnetic Resonance Lymphangiography
Open or (robot-assisted) laparoscopic sentinel node detection and resection.
Eligibility Criteria
Adult patients with histologically proven cervical cancer which are a candidate for surgery, which includes an intra-operative SN procedure and pelvic lymph node dissection. Subjects are derived form a tertiary referral center.
You may qualify if:
- Histologically proven primary malignancy of the cervix uteri;
- Primary therapy is surgery with minimally an intra-operative SN procedure and pelvic lymph node dissection;
- ≥18 years of age and written inform consent provided.
You may not qualify if:
- 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;
- History of an allergic reaction to patent blue V dye;
- Any type of neo-adjuvant chemo and/or radiotherapy for cervical cancer;
- Altered anatomy of pelvic lymph nodal drainage system (e.g. history of retroperitoneal pelvic surgery or trauma).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
Study Sites (1)
UMC Utrecht
Utrecht, Utrecht, 3508 GA, Netherlands
Biospecimen
no biospecimens are to be retained.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald Zweemer, MD PhD
UMC Utrecht
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Gynaecological oncologist
Study Record Dates
First Submitted
January 17, 2013
First Posted
January 28, 2013
Study Start
April 1, 2013
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
December 18, 2014
Record last verified: 2014-12