Clinical trial · Interventional
Evaluation of Viatar™ Oncopheresis System in Removing CTC From Whole Blood
Evaluation of the Saftey and Efficacy of the Viatar™ Oncopheresis System in Removing Circulating Tumor Cells From Whole Blood
NCT03058809CI-TRIAL-00033147unknownPhase 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)
This study will access the safety and efficacy of the Viatar™ Oncopheresis System to remove a meaningful quantity of circulating tumor cells from the blood of subjects' with breast, colon or prostate solid tumor cancers in a single treatment. CTC reduction will be measured as the change in circulating tumor cells as determined before and after treatment.
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 |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oncopheresis | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Metastatic Breast, Colon and Prostate Cancer
- description
- Metastatic breast, colon or prostate cancer patients will have their CTC levels determined on 3 days before treatment with the Viatar Oncopheresis System to establish a baseline value, a pretreatment value, a post treatment value and on 4 additional instances over a period of 7 days post treatment to establish a CTC rebound profile using a validated CTC enumeration system.
- interventionNames
- Device: Oncopheresis
Primary outcomes (1)
- measure
- Change in Circulating Tumor Cells
- timeFrame
- % change will be determined on the day of treatment
- description
- % change in enumerated circulating tumor cells after treatment with Viatar Oncopheresis System
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of breast, colon or prostate cancer * No prior cancer therapy or failed first line therapy * \>= 25 CTC per 7.5 mL of blood within 1 week prior to oncopheresis treatment * \> 1 month life expectancy * Adequate baseline hematological function as assessed by the following laboratory values: * Hemoglobin \> 9 g/dl * Platelets \> 100,000/mm3 * WBC \> 3,000/mm3 * Absolute Neutrophil Count \> 1,500/mm3 Exclusion Criteria: * Coagulation disorders and/or a history of thromboembolic complications, including known hypersensitivity to citrate: e.g., abnormal platelet count, prothrombin time and partial activated thromboplastin time and with a history of deep vein thrombus or pulmonary embolism * Patients with known immunodeficiency virus (HIV)
References
Publications (0)
Data not yet available
No reference posted for this study.