Biopsy After Radioembolization to Identify Changes in Tumor Cells From the Radiation

Study Overview
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Brief Summary
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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.

Official Title
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Correlation of Histopathological Findings With Radiation Exposure Levels After Y90 Transarterial Radioembolization (TARE) of Hepatic Metastases: A Feasibility Study

Conditions
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Colon Cancer Liver Metastasis, Colon Cancer, Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Liver Metastasis Colon Cancer, Colorectal Cancer

Intervention / Treatment
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* Radiation: Y90 TARE
* Diagnostic Test: PET/CT
* Diagnostic Test: PET/MRI


Participation Criteria
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Eligibility Criteria
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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 treatment with radiotherapy - untreated lesions / lobes in the liver may be evaluated under the protocol) severe cirrhosis severe portal hypertension uncorrectable flow to the gastrointestinal tract and/or >30 Gy (or >50 Gy in multiple sessions) radiation absorbed dose to the lungs All patients with liver-dominant disease will be considered candidates for TARE even in the face of oligometastatic (up to 5 sites) extrahepatic disease, that is stable or controlled by chemotherapy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with colorectal cancer liver metastases<br>The study population is represented by patients with colorectal cancer liver metastases that have been deemed clinically appropriate/eligible to receive Y90 TARE for the management of their liver metastases. | Radiation: Y90 TARE<br>* Y90 TARE will be performed as standard of care (SOC)/clinically indicated: 1) in a lobar or sub-lobar fashion (depending on tumor involvement and location; also targeting the tumor as selective as possible and sparing as much as possible of non-involved liver parenchyma), for participants with extensive bilobar disease or 2) in a radiation segmentectomy approach, intending to deliver 190 Gy radiation dose to target tumor: for patients with limited liver metastatic disease, not amenable for surgery or ablation.<br>* Other names: 90Y transarterial radioembolization;Diagnostic Test: PET/CT<br>* Following 90Y TARE, participants will receive a PET/CT or PET/MRI scan to measure the dose administered to the target tumor(s) and uninvolved hepatic parenchyma.<br>Diagnostic Test: PET/MRI<br>* Following 90Y TARE, participants will receive a PET/CT or PET/MRI scan to measure the dose administered to the target tumor(s) and uninvolved hepatic parenchyma.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of tissue necrosis and radiation-induced cell injury levels with delivered dose at 72 hours | Determine the feasibility of correlating tissue necrosis and radiation-induced cell injury levels with delivered dose within the target colorectal cancer liver metastases (CLM) and the uninvolved liver parenchyma. | 72 hours after treatment | 
| Correlation of tissue necrosis and radiation-induced cell injury levels with delivered dose at 14-21 days | Determine the feasibility of correlating tissue necrosis and radiation-induced cell injury levels with delivered dose within the target colorectal cancer liver metastases (CLM) and the uninvolved liver parenchyma. | Between 14-21 days after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal liver metastases, transarterial radioembolization, Y90 TARE, Colon Cancer Liver Metastasis, Colon Cancer, Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Colorectal Cancer, Memorial Sloan Kettering Cancer Center, 20-355