Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT04577950
Eligibility Criteria:
Inclusion Criteria:
* Informed Consent as documented by signature
* Early endometrial cancers (of International Federation of Gynecology and Obstetrics stage IA-IB), whatever histological grade and type
* Primary surgical treatment with hysterectomy
* No metastasis, no other cancers, no recurrency of cancers
* No signs of lymph nodes metastasis on the preoperative workup (MRI +/- positron emission computed tomography)
* No contraindication to laparoscopic procedures.
* Women of \> 18 years
Exclusion Criteria:
* Known severe allergies (antecedents of Quincke oedema, anaphylactic shock,…) and a history of allergy to iodides
* Contraindications to the injected products because of known hypersensitivity or allergy to ICG of blue dye
* Antecedent of pelvic lymph nodes surgery
* Previous lymphadenectomy or surgery that could change the uterine lymphatic drainage (conisation or myomectomy)
* Other diagnosed cancer during treatment or care
* Stage II and above (tumor invading cervix stroma) including those after a neo-adjuvant treatment
* Suspicion of lymph nodes metastasis at preoperative workup
* Medical or uterine conservative treatment
* Patient, who does not understand, speak or write in French
* Drugs that can interfere with ICG : anti convulsants - bisulphite compounds - haloperidol - heroin - pethidine \[meperidine\] - methamizole - methadone - morphine - nitrofurantoin - opium alkaloids - phenobarbitone- phenylbutazone - cyclopropane - probenecid - rifamycin - sodium bisulphite (mostly combined with heparin)
* Radioactive iodine uptake performed less than one week following the use of ICG.
* Hypersensitivity to Nanocoll, to any of the excipients (Stannous chloride, dihydrate Glucose, anhydrous Poloxamer 238 Sodium phosphate, dibasic, anhydrous Sodium phytate, anhydrous) or to any of the components of the labelled radiopharmaceutical.
* A history of hypersensitivity to products containing human albumin
* Hypersensitivity to dyes made of triphenylmethane
* Lymphostasis
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04577950
Study Brief:
Protocol Section:
NCT04577950