- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03680833
Sentinel Node Detection in Cervical Cancer (SLNcxca)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Consecutive women with stage 1a2-2a1 cervical cancer scheduled for surgery will be approached for eligibility by defined criteria.
Sentinel nodes will be detected by a combined use of Indocyanine green and Tc99 radiocolloid ( first 75 patients) and for the continuation with either the combined use or the best performing of those tracers.
Technical success rates, adverse events (related study intervention and overall) sensitivity and negative predictive values will be estimated.
An interim analyse will be performed after 34 node positive patients based on the Fleming two stage analyse. The null hypothesis of sensitivity of 85% will be tested against an estimated sensitivity of 95%. At this stage the study may be closed for futility, closed as hull hypothesis is rejected or continued to reach another 28 node positive patients.
As a full pelvic lymphadenectomy will be performed after detection of sentinel nodes patient will act ast their own controls.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jan Persson, ass professor
- Phone Number: +46733522080
- Email: jan.persson@med.lu.se
Study Contact Backup
- Name: Linnea Ekdahl, MD
- Phone Number: 0739292631
- Email: linnea.ekdahl@med.lu.se
Study Locations
-
-
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Lund, Sweden, 22185
- Recruiting
- Department of Gynecology and Obstetrics
-
Contact:
- Jan Persson, ass professor
- Phone Number: +46733522080
- Email: jan.persson@med.lu.se
-
Contact:
- Linnea Ekdahl, MD
- Phone Number: +46739292631
- Email: linnea.ekdahl@med.lu.se
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women of age 18 years and older at the time of informed consent.
- Women with a pathologically proven cervical carcinoma of any histologic subtype, clinically stage 1a2- 2a1 planned for primary surgery
- Absence of any exclusion criteria
Exclusion Criteria:
- Non consenting patients
- Ongoing pregnancy
- Inability to understand written and/or oral study information
- Who performance status III or more
- Previous lower limb lymphedema
- Surgical contraindication to a laparoscopic approach or lymphadenectomy at surgeons discretion.
- Anesthesiologic contraindication to a laparoscopic approach at the anesthetist's discretion
- Locally advanced disease or intraabdominal/distant metastases at preoperative CT, MRI or ultrasonography
- Radiologically suspect pelvic nodal metastatic disease according to the RECIST criteria (>= 1 node with >=16 mm short axis diameter)
- Allergy to Iodine
- Patients with a known liver disease
- Patients with a significant bleeding disorder or mandatory antithrombotic treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: prospective cohort study
Prospective cohort study with detection of sentinel lymph nodes followed by a full pelvic lymphadenectomy. Patients will act as their own controls. The intervention is the detection and removal of sentinel lymph nodes |
The study intervention is the injection of tracer followed by detection and removal of sentinel lymph nodes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sentinel node detection in cervical cancer; Sensitivity and negative predictive values for identifying pelvic nodal disease, See detailed study protocol
Time Frame: 4-5 years
|
Detection of Sentinel nodes followed by full pelvic lymphadenectomy
|
4-5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jan Persson, ass professor, Region Skane
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RegionSkaneKKLund2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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