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

RECRUITINGN/ASponsored by Fundacion Clinic per a la Recerca Biomédica
Actively Recruiting
PhaseN/A
SponsorFundacion Clinic per a la Recerca Biomédica
Started2023-09-01
Est. completion2026-10
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted

Summary

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

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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

Conditions2

CancerOvarian Epithelial Cancer

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