Cervical CancerNCT01777230
The Value of Preoperative Sentinel Lymph Node Mapping by Pelvic MR Lymphangiography and SPECT-CT in Cervical Cancer
An observational study of Cervical Cancer, run by UMC Utrecht at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- SPECT-CT sentinel node mapping, Magnetic Resonance Lymphangiography sentinel node mapping and Intra-operative sentinel node procedure
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2013to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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).
- Conditions
- Cervical Cancer
- Being tested
- SPECT-CT sentinel node mapping, Magnetic Resonance Lymphangiography sentinel node mapping, Intra-operative sentinel node procedure
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECT-CT sentinel node mappingProcedure or surgery
Also called Single Photon Emission Computed Tomography, Computed Tomography
sentinel node localisation using the nuclear medicine technique SPECT-CT
Magnetic Resonance Lymphangiography sentinel node mappingProcedure or surgery
Sentinel node localisation using Magnetic Resonance Lymphangiography
Intra-operative sentinel node procedureProcedure or surgery
Open or (robot-assisted) laparoscopic sentinel node detection and resection.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Alle subjects included retain in one cohort. Receives: Procedure: SPECT-CT sentinel node mapping; Procedure: Magnetic Resonance Lymphangiography sentinel node mapping; Procedure: Intra-operative sentinel node procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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).
The difference in concordance (imaging to intra-operative results) between two strategies are compared.
- The 1st strategy entails preoperative imaging with SPECT-CT and 'standard' intra-operative SN procedure (= with 99mTc use).
- The 2nd strategy is with preoperative MR lymphangiography and an intra-operative 'blue dye only' SN procedure (= without 99mTc).
Measured: within 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Why it stopped: Unable to get required research materials
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald Zweemer, UMC Utrecht
- Investigators
- Ronald Zweemer, MD PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777230
- Sponsor's protocol ID
- NL43062.041.13
- Status last verified
- Dec 2014
- First submitted
- 17 Jan 2013
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Preoperative Sentinel Lymph Node Mapping by Pelvic MR Lymphangiography and SPECT-CT in Cervical Cancer
- ClinicalTrials.gov ID
- NCT01777230
- Acronym / sponsor ID
- NL43062.041.13
- Conditions
- Cervical Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to get required research materials
- Enrolment
- 0 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 28 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Procedure: SPECT-CT sentinel node mapping, Procedure: Magnetic Resonance Lymphangiography sentinel node mapping, Procedure: Intra-operative sentinel node procedureAlle subjects included retain in one cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- Contra-indications to MR lymphangiography, defined as:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPECT-CT sentinel node mappingAlso: Single Photon Emission Computed Tomography, Computed Tomographysentinel node localisation using the nuclear medicine technique SPECT-CT | Procedure or surgery | All patients |
| Magnetic Resonance Lymphangiography sentinel node mappingSentinel node localisation using Magnetic Resonance Lymphangiography | Procedure or surgery | All patients |
| Intra-operative sentinel node procedureOpen or (robot-assisted) laparoscopic sentinel node detection and resection. | Procedure or surgery | All patients |
Primary outcome
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).
Time frame: within 1 week
3 secondary outcomes
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.
Time frame: 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.
Time frame: 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).
Time frame: within 1 week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Zweemer, MD PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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). (time frame: within 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2014.