Sentinel node detection with technetium-99m albumin nanocolloid and ICG for early epithelial ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with a suspicious adnexal mass or confirmed early-stage epithelial ovarian cancer and no radiologic evidence of nodal or distant spread will receive intraoperative injections of technetium-99m albumin nanocolloid and indocyanine green (ICG). Surgeons will use the radioactive signal and fluorescence to locate and remove sentinel lymph nodes for pathological analysis. The procedure is performed during planned surgical staging or tumor resection to compare detection rates and diagnostic precision of the two tracers. Patients with prior pelvic or para-aortic vascular surgery or radiotherapy, advanced FIGO stage, pregnancy, or inability to obtain tumor biopsy are excluded.

Why it matters

Who can join: the full rules

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

Where it's running

• Laura Burunat
  Barcelona, Catalonia, Spain Recruiting

Study contacts

• Principal investigator: Berta Diaz-Feijoo, Physician — Hospital Clinic of Barcelona
• Study coordinator: Laura Burunat, Graduate
• Email: burunat@recerca.clinic.cat
• Phone: 0034 932275400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.