The CIVOTM device may be used in clinical trials of new oncology agents upon IRB approval of the protocol and FDA IND approval. CIVO may be deployed in trials to gain an improved understanding of complex tumor biology. This type of data can be particularly helpful in understanding drug combinations.
CIVO is currently being evaluated in a clinical study in patients with soft tissue sarcoma in collaboration with the Fred Hutchinson Cancer Research Center, Northwell Health Center for Advanced Medicine, Monter Cancer Center, and the University of Washington. The study evaluates the response to a range of locally injected drugs selected from sixteen approved agents that are either standard of care or are being investigated for use in treating patients with sarcoma. This study is intended to validate the overall coordination of the CIVO system, from the pharmacist loading the device and the investigator performing the injection to the surgeon’s resection of the tumor and subsequent quantitative analysis. No results are reported back to the patients, and no change in the patients’ treatments will result from this initial trial. Patient responses to systemic treatment are being evaluated for concordance with local responses to CIVO device-administered drug microdoses.ClinicalTrials.gov Identifier: NCT03056599