Health TrialsbyHealthPanel

Needle-based Percutaneous Ablation of Liver Tumors.

ConditionsLiver TumorsHCC - Hepatocellular CarcinomaMetastatic Liver Tumor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorinTumo Therapeutics, Inc.

About this trial

The goal of this clinical trial is to learn if INT001 can ablate liver tumors in adults in an outpatient setting. It will also help us learn about the safety of INT001. The main questions it aims to answer are:

1. Using a needle under image guidance, the liver tumor is accessed and INT001 is injected. Upon injection into tumor, does INT001 ablate/kill the tumor entirely? 2. What medical problems do participants experience when receiving INT001?

Participants will:

Receive INT001 on day 1. Visit the clinic day 7, 30 and 90. Receive lab tests during each visit and MRI on day 30 and 90.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of primary or secondary liver cancer.

ECOG Performance Status score of 0 - 2

Age ≥18 years, <100 years

Life expectancy of ≥3 months

Disqualifiers

Decompensated liver function, specifically Child-Pugh C, moderate to severe ascites, coagulopathy, or severe cirrhosis.

Signs of liver dysfunction: AST or ALT >5 times the upper limit of normal (ULN), Serum bilirubin level >2.0 mg/dL

Individuals with bleeding disorders.

History of allergy or intolerance to contrast agents to be used during imaging for assessing treatment efficacy after INT001 application.

Trial design

Design model

Single group

Treatments tested in this trial

  • Needle based delivery of INT001 into liver tumors under real-time image guidance

    Device

    Using ultrasound or CT imaging, the liver tumor is located. Under local anesthesia or, if necessary, intravenous sedation, the needle is inserted through the skin and the needle tip is brought to the center of the liver tumor using image guidance. 1-2 ml of the INT-001 is injected. The needle is removed and a bandaid is applied to the skin entry site. Right after, or as soon as MRI becomes available, MRI is performed to show that the entire tumor has been treated.

Treatment groups

31 Participants
are divided into 1 treatment group
Group A: INT001 TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Ablation

Ablation of the tumor will be assessed using imaging criteria such as RECIST.

Time frame
MRI will be performed the day of the intervention, at 30 days and at 90 days.
2

Adverse events

Procedure-Related and Post-Procedure Complications Complications related to the procedure and the postoperative period

Time frame
From day 1 to day 90

Secondary outcomes

1

Biomarkers

Biomarkers such as AFP will be monitored

Time frame
Day 30 and Day 90

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

inTumo Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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