Clinical trial · Interventional
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
NCT05937620CI-TRIAL-00102843Melisa-IIrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Study to evaluate the diagnostic precision of ICG and 99mTc nanocolloid albumin in sentinel lymph node detection in early ovarian epithelial cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Epithelial Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 99mTC nanocolloid albumin injection | Diagnostic Test | — | UNRESOLVED |
| ICG injection | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Interventional arm
- description
- All patients will receive an injection of ICG and an injection of 99mTc nanocolloid albumin
- interventionNames
- Diagnostic Test: 99mTC nanocolloid albumin injection
- Diagnostic Test: ICG injection
Primary outcomes (1)
- measure
- Evaluation of the diagnostic efficiency of both tracers in sentinel lymph node detection
- timeFrame
- Through study completion (an average of 36 months)
- description
- Global detection rate of sentinel lymph node in patients having received both tracers.
Secondary outcomes (21)
- measure
- Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to morphological characteristics
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.