WOOF for the Cure – Canine Sarcoma Study

Patient Disease:
Canine Soft Tissue Sarcoma (STS)

Study Name:
WOOF for the Cure – STS Study

Purpose of the Study: 
Presage Biosciences is sponsoring the study of a clinical diagnostic device called CIVO™ designed to enable the individual evaluation and prioritization of multiple anti-cancer agents in canine soft tissue sarcoma without exposing the patient to systemic toxicity. During a brief outpatient procedure under sedation, the CIVO device is used to inject microdoses of different anti-cancer drugs or combinations of drugs through the skin and directly into the canine patient’s sarcoma. The mass is then resected by a board-certified veterinary surgeon and transferred to Presage scientists who evaluate each compound’s anti-cancer activity. By developing the clinical capabilities of this technology, Presage hopes to revolutionize personalized medicine and eliminate patient exposure to ineffective therapies. 

Primary Eligibility Criteria:
•    Mass equal to or greater than 3.5 cm (width and length) and accessible for injection through overlying skin
•    Cytology or biopsy report indicating that the mass is a presumptive soft tissue sarcoma
•    No contraindications to anesthesia or surgery
•    Patient is clinically stable enough to delay surgery until 48 hours post-microinjection
    
Study Protocol:

•    Non-randomized trial
•    The mass will be screened via ultrasound for CIVO microinjection. 
•    Micro-doses of several drugs or drug combinations will be administered directly into the mass during a brief outpatient procedure under sedation.
•    48 hours later, surgical resection will be performed by a board-certified veterinary surgeon and the tissue will be analyzed by Presage scientists to determine the anti-cancer activity of each injected compound. 

Study Budget:
The following services are covered by the study when performed by the participating veterinary clinic: 
•    Cytological confirmation of sarcoma, unless recently performed
•    Blood and urine testing, unless recently performed
•    Thoracic radiographs, unless recently performed
•    Costs associated with the injection procedure
•    $1500 towards surgical resection of the sarcoma
•    Histopathological evaluation of sarcoma tissue post-resection

Owner Responsibilities:
•    Follow appointment schedule required by study protocol
•    Cover all costs associated with treatment other than those funded by the study