Sentinel node detection with technetium-99m albumin nanocolloid and ICG for early 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
NA · Fundacion Clinic per a la Recerca Biomédica · NCT05937620
This study will test whether combining a radioactive tracer (technetium-99m albumin nanocolloid) and a fluorescent dye (ICG) helps surgeons find sentinel lymph nodes in people with early epithelial ovarian cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fundacion Clinic per a la Recerca Biomédica (other) |
| Locations | 1 site (Barcelona, Catalonia) |
| Trial ID | NCT05937620 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: People with a high-suspicion adnexal mass or confirmed early-stage epithelial ovarian cancer who have no imaging evidence of retroperitoneal or distant metastases and who can consent to intraoperative injection and sentinel node biopsy are ideal candidates.
Not a fit: Patients with advanced disease (FIGO III/IV), pregnancy or breastfeeding, prior pelvic/para‑aortic vascular surgery or radiotherapy, inability to obtain tumor biopsy, or those under 18 are unlikely to benefit from this procedure.
Why it matters
Potential benefit: If successful, the approach could allow more accurate sentinel node identification and potentially reduce the need for extensive lymph node dissection and its associated complications.
How similar studies have performed: Small series and preliminary studies have demonstrated feasibility of sentinel node mapping in ovarian cancer using ICG or radiocolloid, but larger confirmatory data are still limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Barcelona, Catalonia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ovarian Epithelial Cancer