RecruitingNot ApplicableNCT05937620
Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and ICG in Patients With Epithelial Ovarian Cancer
Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and Indocyanine Green (ICG) in Patients With Epithelial Ovarian Cancer in Early Stages: Pilot Study
Sponsor
Fundacion Clinic per a la Recerca Biomédica
Enrollment
62 participants
Start Date
Sep 1, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
Study to evaluate the diagnostic precision of ICG and 99mTc nanocolloid albumin in sentinel lymph node detection in early ovarian epithelial cancer.
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria4
- 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 Criteria9
- 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
Interventions
DIAGNOSTIC_TEST99mTC nanocolloid albumin injection
All patients will receive an injection of both tracers in order to detect the sentinel lymph node
DIAGNOSTIC_TESTICG injection
All patients will receive an injection of both tracers in order to detect the sentinel lymph node
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05937620