Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and ICG in Patients With Epitheli⦠(NCT05937620) | Clinical Trial Compass
RecruitingNot Applicable
Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and ICG in Patients With Epithelial Ovarian Cancer
Spain62 participantsStarted 2023-09-01
Plain-language summary
Study to evaluate the diagnostic precision of ICG and 99mTc nanocolloid albumin in sentinel lymph node detection in early ovarian epithelial cancer.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with adnexal mass diagnosed with high suspicion of malignancy that will undergo intraoperative biopsy or patients with already diagnosed epithelial cancer in early stages in a previous surgery and confirmed by pathology with complete staging indicated.
* Absence of retroperitoneal ganglionary affectation and metastatic disease evaluated by preoperative imaging techniques.
* Signing of informed consent by the patient or relative in charge.
* Women with childbearing potential must compromise to use highly effective contraceptive methods (partner vasectomized, sexual abstinence) until the end of the study (last study visit).
Exclusion Criteria:
* Patients \<18 years
* Pregnancy or breastfeeding
* Epithelial ovarian tumors stage FIGO III or IV.
* Impossibility to obtain a biopsy from the tumor.
* History of previous vascular surgery (cava vein, aorta, iliac blood vessels) or radiotherapy in pelvic or para-aortic area.
* Sentinel lymph node biopsy will not be performed if intraoperative histologic study shows a benign ovarian tumor, low malignancy potential tumor or expansive mucinous histology.
* Patient not able to undergo surgery.
* Hypersensitivity to active principle, to sodium iodide or iodine allergy.
* Patients with clinic hyperthyroidism, thyroid autonomous adenomas or focal and diffused autonomous alteration of thyroid gland
What they're measuring
1
Evaluation of the diagnostic efficiency of both tracers in sentinel lymph node detection
Timeframe: Through study completion (an average of 36 months)