NCT03056599

Precise Local Injection of Anti-cancer Drugs Using Presage's CIVO Device in Soft Tissue Sarcoma

Feasibility of Assessing Drug Response to Precise Local Injection of Anti-cancer Drugs Using Presage's CIVO Device in Soft Tissue Sarcoma Patients Undergoing Surgery.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Presage Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a feasibility study in patients with localized or metastatic soft tissue sarcoma undergoing surgery to determine how sarcoma in situ responds to injected microdoses of anti-cancer therapeutics.

Detailed description

This is a single arm, pilot study designed to test the feasibility of using the CIVO (Comparative In Vivo Oncology) system in patients with soft tissue sarcoma accessible for percutaneous injection. Patients who are scheduled for surgical biopsy or tumor resection surgery will be injected 4 to 72 hours prior to surgery using the CIVO device. Minute volumes (up to 8.3 microliters) of saline (negative control) or microdoses of anti-cancer agents will be percutaneously injected in a columnar fashion through each of 8 needles into a single solid tumor. Following the patient's biopsy surgery or tumor resection surgery, the injected portion and a small uninjected portion will be used to determine the in situ drug response in the tumor. None of the data from this evaluation will be shared with patients or used to make clinical decisions. Study clinicians will have access to the patient's health record for 1 year after the study to monitor patient treatment responses. Such information will be used to help evaluate the correlation between clinical response and tumor response assessed via CIVO.

Conditions

• Soft Tissue Sarcoma Adult

Interventions

Type	Name	Description
DRUG	Multiple drug microinjection	This is a feasibility study in patients with localized or metastatic soft tissue sarcoma undergoing surgery to determine how sarcoma in situ responds to injected microdoses of anti-cancer therapeutics.
DEVICE	CIVO device	Feasibility of assessing drug response to precise local injection of anti-cancer drugs using Presage's CIVO device in soft tissue sarcoma patients undergoing surgery.

Timeline

• Start date: 2016-12-15
• Primary completion: 2021-07-22
• Completion: 2021-09-22
• First posted: 2017-02-17
• Last updated: 2021-09-24

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study