Health TrialsbyHealthPanel

Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM)

ConditionColorectal Liver Metastases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSociety of Interventional Oncology

About this trial

To demonstrate that microwave ablation (MWA) of up to 3 hepatic metastases, each with a maximum diameter of ≤ 2.5 cm will result in a 2-year local progression free survival of at least 90%. This is a standard of care (SOC) study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient must be at least 18 years old.

Patient has signed a written informed consent for the MWA and participation in the study.

Patient with pathologically confirmed CRC with hepatic metastases confirmed on imaging (e.g., CT or MRI).

Patient has up to 3 hepatic metastases, each up to 2.5 cm in largest diameter.

Disqualifiers

Patient is unable to lie flat or has respiratory distress at rest.

Patient has uncontrolled and uncorrectable coagulopathy or bleeding disorders.

Patient has a history of an allergic reaction to intravenous iodine that cannot be pre-medicated or prevents performance of a CT with IV contrast.

Patient has evidence of active systemic infection.

Trial design

Design model

Single group

Treatments tested in this trial

  • Microwave ablation

    Device

    Microwave ablation of colorectal liver metastases (CLM)

Treatment groups

275 Participants
are divided into 1 treatment group
Group A: Microwave ablation with margin confirmationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Local tumor progression free survival at 24 months

See Above

Time frame
24 Months

Secondary outcomes

1

Hepatic progression free survival by Kaplan-Meier estimate

See Above

Time frame
24 Months
2

Local tumor progression free survival between sufficient (5.0-9.9 mm) and ideal (≥10 mm) ablation margin categories using Kaplan-Meier methodology and the log-rank test

See Above

Time frame
24 Months
3

Progression free survival using Kaplan-Meier methodology and the log-rank test

See Above

Time frame
24 Months
4

Overall and disease specific survival following MWA using Kaplan-Meier methodology

See Above

Time frame
24 Months

Other outcomes

Sponsors and contacts

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

Society of Interventional Oncology

Lead sponsor

Source ClinicalTrials.gov
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