Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and ICG in Patients With Epithelial Ovarian Cancer

Recruiting now · Not applicable

Conditions studied: Ovarian Epithelial Cancer

In brief

Study to evaluate the diagnostic precision of ICG and 99mTc nanocolloid albumin in sentinel lymph node detection in early ovarian epithelial cancer.

Key facts

Study ID

NCT05937620

Run by

Fundacion Clinic per a la Recerca Biomédica

People needed

62

Starts

2023-09-01

Expected to finish

2026-10-01

Last updated by the study team

2026-02-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Laura Burunat — Barcelona, Catalonia, Spain (enrolling)

Full record on ClinicalTrials.gov

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