NCT04668872 Biopsy After Radioembolization to Identify Changes in Tumor Cells From the Radiation
| NCT ID | NCT04668872 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Colon Cancer Liver Metastasis |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2020-12-07 |
| Primary Completion | 2026-12-07 |
Trial Parameters
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Brief Summary
The purpose of this study is to study the way radioembolization works by collecting biopsy samples of participants' tumors after the procedure. This research may improve the way that radioembolization is performed, which could help people whose cancer has spread to the liver. The research may also provide information about how tumors respond to radioembolization.
Eligibility Criteria
Inclusion Criteria: * age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * histologically confirmed primary adenocarcinoma of the colon or rectum * CLM considered unresectable or not amenable to percutaneous ablation * existent tissue samples from a standard of care biopsy of the target tumor within 42 days prior to treatment OR clinical indication for biopsy at the time of the treatment under the institutional guidelines for progression of disease. * adequate blood cell counts (WBC \> 1.5 x 109/L, platelet count \> 50 x 109/L) * adequate renal function (creatinine \< 1.5 mg/dL) * total bilirubin level ≤ 1.5 mg/dL Additional inclusion criteria for patients, undergoing 90Y radiation segmentectomy: A. patients not amenable to surgery or thermal ablation Exclusion Criteria: Study exclusion criteria will be similar to general TARE exclusion criteria, which are as follows: * prior hepatic radiotherapy (The lesion / lobe being treated cannot have had prior trea
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