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Befejeződött4. fázis

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

Key facts

Where
Utrecht, HollandiaSee the site
Phase
4. fázis

Where in Hollandia

  • Universitair Medisch Centrum UtrechtUtrecht, HollandiaNo longer taking part

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Trial details

Who runs it
Universitair Medisch Centrum Utrecht
Trial code
EU 2024-511966-36-00
Record updated
2024. május 10.
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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.

Exclusion: 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.

EU CTIS 2024-511966-36-00