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2023-505667-37-00CompletedPhase 2

Sentinel node detection with 99Tc albumin nanocolloid and indocianine green (ICG) in patients with epithelial ovarian cancer in early stages. Pilot study.

Source: EU CTIS (euclinicaltrials.eu) · Last updated 24 Jun 2024

Next steps

Brief summary (registry, in English)

To evaluate the diagnostic efficiency of both tracers in sentinel lymph node detection

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
62 (actual)
First submitted
19 Jun 2023
Start date
6 Oct 2023
Lead sponsor
Fundacio De Recerca Clinic Barcelona-Institut D’investigacions Biomediques August Pi I Sunyer
EU CT number
2023-505667-37-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 62
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Lab values

  • 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

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hospital Clinic de BarcelonaBarcelonaSpainCompleted

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