2024-511966-36-00CompletedPhase 4
The bilateral sentinel node detection rate of fluorescent indocyanine green compared to 99mTc and blue dye inthe sentinel node procedure in stage I-IIA cervical cancer
The bilateral sentinel node detection rate of fluorescent indocyanine green compared to 99mTc and blue dye in the sentinel node procedure in stage I-IIA cervical cancer
Source: EU CTIS (euclinicaltrials.eu) · Last updated 10 May 2024
Brief summary (registry, in English)
To evaluate the bilateral SLN detection rate of intraoperative ICG with NIR fluorescence imaging compared to the current standard of care of 99mTc (with preoperative SPECT/CT) and blue dye.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 101 (actual)
- First submitted
- 25 Apr 2024
- Start date
- 26 Apr 2021
- Lead sponsor
- Universitair Medisch Centrum Utrecht
- Diseases
- Cervical cancer
- EU CT number
- 2024-511966-36-00
- EudraCT number
- 2020-005134-15
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 101
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pregnancy or current breastfeeding (confirmation by a pregnancy test is the current standard of care) - Renal insufficiency stage 3 or 4. - Prior allergic reaction to ICG, 99mTc or patent blue. - Prior severe allergic reaction to iodine
Who the study is looking for
- 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 guidelines39); - Radical surgery is planned including a SLN procedure.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Medisch Centrum Utrecht | Utrecht | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.