Recruiting
Phase 2
Phase 3

Observational Study

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT04143516

Conditions

Liver Metastases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[18-F]- FDG - PET

Tumor ablation (TA)

PET/CT Scan

Study Details

Brief summary:

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.

Conditions

Liver Metastases

Study ID

NCT04143516

Start date

Oct 25, 2019

Status verified date

Mar, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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\*\*\*
  • INR < 1.5\*
  • Platelet count ≥ 50,000

Exclusion Criteria:

  • 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
  • More than 3 tumors in the liver
  • More than 5 tumors of extrahepatic disease (including mediastinal nodes and pulmonary nodules, abdominal or other lymph nodes, and bone metastasis)
  • Presence of any peritoneal Carcinomatosis

  • For patients on Coumadin, general clinical guidelines for IR ablation will be followed.

  • For patients with no FDG-PET avid tumors aim 2 of the protocol will not be assessed

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

[18-F]- FDG - PET

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

Tumor ablation (TA)

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

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.

Primary outcome measure

  • Tumor response [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Constantinos Sofocleous, MD, PhD

212-639-3379sofoclec@mskcc.org

Efsevia Vakiani, MD,PhD

646-888-3060

Locations

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Constantinos Sofocleous, MD, PhD

212-639-3379

Efsevia Vakiani, MD,PhD

646-888-3060

Principal Investigator:

Constantinos Sofocleous, MD,PhD

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Keywords

  • Optimizing Tumor Ablation
  • Rapid Tissue Analysis
  • Metabolic Imaging Biomarker Validation
  • Predictive Genetic Signatures
  • 19-332

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-03-19.