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

NCT03056599 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2021-09-24

No results posted yet for this study

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.

Conditions

  • Soft Tissue Sarcoma Adult

Interventions

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.

Sponsors & Collaborators

  • Fred Hutchinson Cancer Center

    collaborator OTHER

  • University of Washington

    collaborator OTHER

  • Northwell Health

    collaborator OTHER

  • Oregon Health and Science University

    collaborator OTHER

  • Presage Biosciences

    lead INDUSTRY

Principal Investigators

  • Gary Deutsch, MD · Northwell Health

  • Kenneth Gundle, MD · Oregon Health & Science University (OHSU)

  • Seth Pollack, MD · Fred Hutchinson Cancer Research Center/SCCA

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-15
Primary Completion
2021-07-22
Completion
2021-09-22
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03056599 on ClinicalTrials.gov