Clinical trial · Interventional
Imaging of Peritoneal Carcinomatosis From Ovarian Carcinoma Patients
Feasibility Study of the (Intravenously Injected) Indocyanine Green (ICG) Imaging of Tumoral Implants in Patients With Peritoneal Carcinomatosis From Ovarian Carcinoma
NCT01834469CI-TRIAL-00015838OV-AP-ICG-IVcompletedPhase 1 / Phase 2ClinicalTrials.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)
The purpose of this study is to determine if NIF fluorescent imaging is an effective approach to detect the gross ovarian tumoral tissues and peritoneal implants in Ovarian cancer patients.
Conditions
Conditions (2)
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 Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| iv injection of ICG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- ICG NIR imaging
- description
- see Summary and description iv injection of ICG
- interventionNames
- Drug: iv injection of ICG
Primary outcomes (1)
- measure
- Feasibility study of the (intravenously injected) ICG imaging of tumoral implants in patients with peritoneal carcinomatosis from ovarian carcinoma
- timeFrame
- 1 year
- description
- Evaluation of the feasibility of NIF imaging to detect tumoral implants in patients with peritoneal carcinomatosis from ovarian carcinoma, the efficacy of this approach will be confirmed by histological test of the dissected tissue.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients (either newly diagnosed, or relapsing) with histo-pathological diagnosis of ovarian carcinoma and peritoneal carcinomatosis who are candidate for "open" surgery, either after neo-adjuvant chemotherapy (80-90% of the cases), or in "first intent". * Informed consent form signed. Exclusion Criteria: * Age less than18 years old. * Inability to give informed consent. * History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish. * Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland. * Documented coronary disease. * Advanced renal impairment (creatinine \> 1,5mg/dl).
References
Publications (0)
Data not yet available
No reference posted for this study.