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

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT04143516
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Liver Metastases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [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
    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.

Study Details

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.

Key Dates

Start date
Oct 25, 2019
Status verified
Mar 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Patients with Liver Metastases
    The standard of care tumor ablation procedure, post-ablation biopsies and pre- and post-ablation PET scans. If the PET scan is positive (shows areas of cancer in the treated metastases), study participants will undergo additional needle biopsies of the positive areas on the scan. If the biopsies show areas of cancer cells that are still alive, the participants will be immediately retreated with a second ablation procedure.

Primary Outcome Measure

Tumor response [ Time Frame: 2 years ]

Central Contacts

  • Constantinos Sofocleous, MD, PhD
    212-639-3379
    [email protected]
  • Efsevia Vakiani, MD,PhD
    646-888-3060

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Constantinos Sofocleous, MD, PhD
212-639-3379
Efsevia Vakiani, MD,PhD
646-888-3060
Constantinos Sofocleous, MD,PhD (PRINCIPAL_INVESTIGATOR)

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