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

Fundacion Clinic per a la Recerca Biomédica

Status

Not yet enrolling

Conditions

Ovarian Epithelial Cancer

Treatments

Diagnostic Test: 99mTC nanocolloid albumin injection

Diagnostic Test: ICG injection

Study type

Interventional

Funder types

Other

Identifiers

2023-505667-37-00

Details and patient eligibility

About

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

Enrollment

62 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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