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Sentinel node detection with 99Tc albumin nanocolloid and indocianine green (ICG) in patients with epithelial ovarian cancer in early stages. Pilot study.
EU CTIS ID: 2023-505667-37-00
What this study is testing
To evaluate the diagnostic efficiency of both tracers in sentinel lymph node detection
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. 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 stadification indicated. 2. Absence of retroperitoneal ganglionary affectation and metastatic disease evaluated by preoperative imaging techniques. 3. Signing of informed consent by the patient or relative in charge. 4. 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).
You likely can't join if
- 1. Patients <18 years 2. Pregnancy or breastfeeding 3. Epithelial ovarian tumors stage FIGO III or IV. 4. Impossibility to obtain a biopsy from the tumor. 5. History of previous vascular surgery (cava vein, aorta, iliac blood vessels) or radiotherapy in pelvic or para-aortic area. 6. 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. 7. Patient not able to undergo surgery 8. Hypersensitivity to active principle, to sodium iodide or iodine allergy. 9. Patients with clinic hyperthyroidism, thyroid autonomous adenomas or focal and diffused autonomous alteration of thyroid gland
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.