Tissue Analysis After Tumor Ablation for Liver Metastases Leading to Immediate Retreatment

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

This study will see whether collecting and analyzing needle biopsy samples from cancer liver metastases after a tumor ablation procedure will be able to identify cancer cells that are still alive. The results of these biopsies could help determine the next treatment for your cancer, but the biopsies could cause side effects.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of liver metastases from various primary tumors

Confined liver disease or limited extrahepatic disease stable/controlled for at least 4 months (extrahepatic disease amenable to treatment is allowed)

Lesions of ≤3 cm in maximum diameter

At least one FDG-avid lesion to be treated***

Disqualifiers

Age < 18

Less than 5 mm distance to a structure (GI or biliary tract), that cannot be protected from ablation injury with technical modifications such as hydro or air dissection

INR > 1.5 that cannot be corrected with fresh frozen plasma **

Platelet count of <50,000 that cannot be corrected with transfusion

Trial design

Design model

Single group

Treatments tested in this trial

  • [18-F]- FDG - PET

    Diagnostic test

    Patients will undergo a limited non-contrast CT and first injection PET to localize the lesion

  • Tumor ablation (TA)

    Procedure/Surgery

    Standard ablation with the intent to create a radius of ablation at least 10 mm larger than the largest lesion diameter in order to achieve a minimum of 5 mm ablation margin around the tumor. Any radiographically-identified and biopsy-confirmed residual tumor will be treated on site with immediate ablation. This repeat ablation is not standard of care but will be performed as described for the initial ablation (in the same procedure session) and follow up will be resumed.

  • PET/CT Scan

    Diagnostic test

    Eligible patients will undergo PET/CT -guided tumor ablation as per standard IR guidelines. All patients will undergo PET/CT again, within approximately 6 weeks (+/- 2 weeks) of tumor ablation to evaluate for CN in the target tumor(s) or any sign of residual tissue enhancement, representing viable residual tumor and incomplete treatment.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Patients with Liver MetastasesExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Tumor response

will be measured according to RECIST and PERCIST 1.0. The first CT and PET scan taken after ablation will be considered the new baseline for subsequent comparisons and measurements.

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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