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

Launched by FUNDACION CLINIC PER A LA RECERCA BIOMÉDICA · Jul 6, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at new ways to detect sentinel lymph nodes in women with early-stage ovarian epithelial cancer. Sentinel lymph nodes are the first nodes in the lymphatic system that cancer is likely to spread to. The study will use two imaging agents, Technetium-99m Albumin Nanocolloid and ICG, to see how accurately they can identify these nodes during surgery. This is important because knowing whether cancer has spread helps doctors plan the best treatment for patients.

To be eligible for this trial, participants must be women aged 65 to 74 who have an adnexal mass (a growth near the ovaries) that is highly suspected to be cancerous, or those who have already been diagnosed with early-stage ovarian cancer. They should not have any signs of cancer spreading to other parts of the body, and they need to agree to use effective birth control if they are able to become pregnant. If they join the study, participants can expect to undergo surgery where the new imaging techniques will be used to help guide their treatment. It's important to note that this trial is not yet recruiting participants, so it will begin at a later date.

Gender

FEMALE

Eligibility criteria

• 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