Precise Local Injection of Anti-cancer Drugs Using Presage's CIVO Device in Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT03056599|
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : September 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma Adult||Drug: Multiple drug microinjection Device: CIVO device||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||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.|
|Actual Study Start Date :||December 15, 2016|
|Actual Primary Completion Date :||July 22, 2021|
|Actual Study Completion Date :||September 22, 2021|
Experimental: Multiple drug microinjection
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 enlarged solid tumor.
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.
- Quantification of fraction of cells positive for apoptosis and drug target engagement biomarkers around injected drugs [ Time Frame: 4-72 hours after microinjection ]Analysis will be performed to determine if there is a difference in responses caused by each drug versus the vehicle control
- Number of patients with adverse events related to pain [ Time Frame: up to 28 days after microinjection ]Relationship of AE to study device or study procedure will be determined using an AE Relatedness Grading System.
- Coefficient of variation and intra-class correlation coefficient of fraction of cells around injected drug in multiple tumor planes [ Time Frame: 4-72 hours after microinjection ]Analysis will be performed for fraction of cells positive for apoptosis and drug target engagement biomarkers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056599
|United States, New York|
|Monter Cancer Center (Northwell Health)|
|Lake Success, New York, United States, 11042|
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239|
|United States, Washington|
|Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance (SCCA)/University of Washington|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Gary Deutsch, MD||Northwell Health|
|Principal Investigator:||Kenneth Gundle, MD||Oregon Health & Science University (OHSU)|
|Principal Investigator:||Seth Pollack, MD||Fred Hutchinson Cancer Research Center/SCCA|