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Phase 0 Master Protocol for CIVO Intratumoral Microdosing of Anti-Cancer Therapies

Testing small doses of cancer treatments directly in tumors.

Recruiting
18 years and older
All
Phase N/A

Study Purpose: This research aims to understand how anti-cancer drugs work in solid tumors using a tool called the CIVO device, which injects tiny amounts directly into the tumor.

CIVO Device: The CIVO device injects very small doses of up to eight different cancer drugs into the tumor. It uses special markers to show where the drugs were injected, helping doctors see how the tumor reacts when it's removed during scheduled surgery.

Key Aspects:

  • Study Duration: Participants will undergo surgery 4 hours to 7 days after the injection.
  • Participation Requirements: Must be 18 or older with a surface-accessible solid tumor and agree to the study's schedule.
  • Safety Measures: Tumors close to critical structures or those causing risks are not eligible.

Eligibility: To join, you need to be willing to follow the study rules, sign a consent form, and have a tumor that can be accessed by the CIVO device. Women must use effective birth control or be unable to have children, and men must use barrier methods or abstain from sexual activity.

Study details
    Solid Tumor

NCT04541108

Presage Biosciences

13 December 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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