A preclinical feasibility study evaluating the use of Deep CIVO, a novel intra-tumoral micro-injection device, in canine patients

This is a multi-site prospective 6-9 patient escalation study with 3 canine patients per group, each group having progressively more difficult to access tumors that measure >5cm in diameter. The first group will consist of canine patients with tumors that are superficial, just below the skin; the second group will consist of canine patients with tumors that are submuscularorlocated such that there is > 3.5 cm of intervening normal tissue between the tumor and the skin surface; and the third group will consist of canine patients with tumors that are intra-cavitary (i.e., intra-abdominal). The Deep CIVO injection system consists of (1) five custom-designed 25-gauge stainless steel hypodermic needles multiplexed into a single cylindrical 12-gauge outer cannula and triggered to extend up to 4 cm beyond the end of the cannula into the tumor by the action of a single lever; (2) a cartridge magazine with up to 5 loaded vials containing saline and fluorescent tracking microspheres; and (3) visualization lights and glasses which enable visualization of the fluorescent tracking microspheres during surgical excision of the injected mass. Ultrasound-guidance helps target the CIVO device to the optimal location and depth within the tumor. Following insertion of the needles into the tumor, microliter volumes of saline and/or drug, mixed with the fluorescent tracking microspheres, will be injected in a columnar fashion through each needle into a single solid tumor. Following the injection procedure, the tumor will be excised either immediately following the injection or within 1-3 days according to standard of care surgical oncological principles. Adverse events will be monitored on an ongoing basis throughout the study. When the first group of patients has been enrolled, an interim analysis may be conducted to evaluate safety and feasibility. After the second group of patients has been enrolled, a second interim analysis may be conducted. Patients will be on study for approximately 2 months. Screening: days -28 to 0; Treatment (injection procedure and tumor removal: days 1-7; Follow-up: one visit between day 11 and 21 and one visit on day 29 (2).

https://veterinaryclinicaltrials.org/study/VCT21005341