Liver MetastasesNCT07871253
Therapeutic Efficacy and Safety of Ultrasound-Guided Microwave Ablation for Hepatic Metastatic Nodules
A study testing Ultrasound-Guided Microwave Ablation in people with Liver Metastases and Hepatic Metastases, run by Assiut University.
Trial summary
The liver is one of the most common organs where cancer cells spread (metastasize) from other parts of the body, especially from gastrointestinal cancers such as colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastases, Hepatic Metastases, Secondary Malignant Neoplasm of Liver
- What is being tested?
- Ultrasound-Guided Microwave Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 years or older.
- Proven clinical and imaging diagnosis of hepatic metastatic nodules referred for percutaneous microwave ablation.
- Single hepatic nodule with a maximum diameter of ≤4 cm, or up to 3 nodules with the maximum diameter of the largest target nodule ≤3 cm.
- Target hepatic metastatic nodules clearly visible and acoustically accessible via conventional transabdominal ultrasound.
- Voluntary provision of written informed consent prior to study enrollment.
Who cannot join
- Extensive, diffuse, or multifocal bilobar hepatic metastases (>3 nodules) or massive extrahepatic disease burden.
- Severe uncorrected coagulopathy or bleeding diathesis (INR > 1.5 or baseline platelet count < 50,000/µL).
- General contraindications for percutaneous microwave ablation.
- Poor acoustic window preventing adequate real-time ultrasound visualization and needle guidance.
- Pregnant or lactating women.
About this study
Official title: Evaluation of Therapeutic Efficacy and Safety of Ultrasound-Guided Microwave Ablation for Hepatic Metastatic Nodules
The liver is one of the most common organs where cancer cells spread (metastasize) from other parts of the body, especially from gastrointestinal cancers such as colorectal cancer. While surgical removal of liver tumors has traditionally been the standard treatment, most patients are not candidates for surgery due to tumor location, number of lesions, or underlying liver function. For these individuals, minimally invasive local therapies such as microwave ablation (MWA) provide an alternative approach to eradicate tumor tissue while preserving healthy liver parenchyma.
Microwave ablation delivers localized high-frequency electromagnetic energy through a thin needle antenna placed percutaneously into the liver tumor. The generated heat induces rapid coagulative necrosis, destroying cancer cells within the target area. In this study, real-time ultrasound combined with CT image-fusion navigation is used to precisely position the ablation antenna within each nodule.
The primary purpose of this study is to assess the therapeutic efficacy and safety of ultrasound-guided percutaneous microwave ablation for patients with liver metastases. Participants receive microwave ablation for their target liver tumors and are evaluated with contrast-enhanced CT or MRI at 1 month post-procedure to determine the rate of complete tumor ablation. Patients are then monitored longitudinally at 3, 6, 9, and 12 months to evaluate safety and check for local tumor recurrence.
- Conditions
- Liver Metastases, Hepatic Metastases, Secondary Malignant Neoplasm of Liver, Colorectal Cancer Metastatic
- Being tested
- Ultrasound-Guided Microwave Ablation
- Keywords
- Microwave ablation, MWA, Ultrasound-guided ablation, Percutaneous ablation, Thermal ablation, Interventional radiology, Image fusion guidance, Local tumor progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Microwave AblationProcedure or surgery
Percutaneous thermal ablation targeting hepatic metastatic nodules using the MaxBlate® Microwave Ablation System operating at a generator frequency of 2450 MHz with internally water-cooled antennas (15G or 16G, shaft length 100-300 mm). Puncture and antenna placement are guided by real-time transabdominal ultrasound paired with pre-acquired contrast-enhanced CT image-fusion software. Thermal energy is delivered at 50 W to 100 W for 5 to 10 minutes per ablation cycle to produce coagulative necrosis encompassing the lesion and an ablative margin.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided Microwave Ablation | Experimental | Participants undergo percutaneous microwave ablation (MWA) targeting hepatic metastatic nodules using the MaxBlate® Microwave Ablation System (2450 MHz) with internally water-cooled antennas (15G or 16G, shaft length 100-300 mm). Needle targeting is conducted under real-time ultrasound guidance integrated with pre-acquired contrast-enhanced CT image-fusion navigation. Ablation power is calibrated between 50 W and 100 W for cycle run-times of 5 to 10 minutes based on nodule dimensions and anatomical location to achieve complete coagulative thermal necrosis. Receives: Procedure: Ultrasound-Guided Microwave Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Ablation Rate
Assessed via contrast-enhanced computed tomography (CECT) or gadoxetic acid-enhanced magnetic resonance imaging (EOB-MRI). Complete ablation is defined as multi-phase imaging demonstrating a distinct, non-enhancing zone of thermal necrosis that completely encompasses the margins of the target metastatic lesion. Incomplete ablation is defined as the presence of nodular, irregular, or focal contrast enhancement along the ablation margin during the arterial or portal venous phases. The outcome is reported as the percentage of targeted nodules achieving complete necrosis.
Measured: 1 month post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver MetastasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Mohamed Adel Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871253
- Sponsor's protocol ID
- MWA for Hepatic Metastases
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No