SENSEI® system for detecting sentinel lymph nodes in cervical cancer

Feasibility of the SENSEI® laparoscopic tethered gamma probe system for 99mTc-nanocolloid sentinel lymph node biopsy in early-stage cervical cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON28547

Enrollment

Registered

2021-03-23

Start date

2021-04-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early-stage cervical cancer

Interventions

None listed

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Sentinel lymph node detection rate (defined as the in vivo detection of at least one sentinel lymph node in each patient).	—

Secondary

Measure	Time frame
- The duration of the sentinel lymph node biopsy (SLNB), defined as the time between the in vivo introduction of the SENSEI® gamma probe and the removal of the SENSEI® gamma probe after checking the surgical site for residual radioactivity (the last step of the SLNB). Track of time is temporarily stopped when the rigid gamma probe is used for validation; - The number of sentinel lymph nodes detected with the SENSEI® system in comparison with the pre-operative Single Photon Emission Computed Tomography (SPECT)-CT and the conventional rigid probe; - The intraoperative adverse events of the SENSEI® system in comparison to the conventional rigid laparoscopic gamma probe; - The ease of use of the SENSEI® laparoscopic tethered gamma probe system; this will be validated with a questionnaire filled in by the surgeons postoperatively. This questionnaire is based on the questionnaire constructed by LightPoint Medical Ltd which used in other clinical trials on the SENSEI® laparoscopic tethered gamma probe system (mainly prostate cancer).	—

Measure

Time frame

- The duration of the sentinel lymph node biopsy (SLNB), defined as the time between the in vivo introduction of the SENSEI® gamma probe and the removal of the SENSEI® gamma probe after checking the surgical site for residual radioactivity (the last step of the SLNB). Track of time is temporarily stopped when the rigid gamma probe is used for validation; - The number of sentinel lymph nodes detected with the SENSEI® system in comparison with the pre-operative Single Photon Emission Computed Tomography (SPECT)-CT and the conventional rigid probe; - The intraoperative adverse events of the SENSEI® system in comparison to the conventional rigid laparoscopic gamma probe; - The ease of use of the SENSEI® laparoscopic tethered gamma probe system; this will be validated with a questionnaire filled in by the surgeons postoperatively. This questionnaire is based on the questionnaire constructed by LightPoint Medical Ltd which used in other clinical trials on the SENSEI® laparoscopic tethered gamma probe system (mainly prostate cancer).

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Contacts

Public ContactIlse Baeten

UMC Utrecht

i.g.t.baeten@umcutrecht.nl+31 88 75 530 68

Outcome results