SENSEI® system for detecting sentinel lymph nodes in cervical cancer
Completed
- Conditions
- Early-stage cervical cancer
- Registration Number
- NL-OMON28547
- Lead Sponsor
- MC Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Age =18 years and able to provide informed consent;
- A histopathologically proven primary malignancy of the cervix uteri;
- FIGO stage IA1-IB2 or IIA1 (according to the FIGO 2018 guidelines);
- Robot-assisted radical surgery is planned with a SLNB and bilateral pelvic lymph node dissection (current standard of care)
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy or current breastfeeding (confirmation by a pregnancy test is the current standard of care).
- Prior allergic reaction to 99mTc-nanocolloid.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sentinel lymph node detection rate (defined as the in vivo detection of at least one sentinel lymph node in each patient).
- Secondary Outcome Measures
Name Time Method