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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Colon Cancer; Liver Metastasis Colon Cancer; Adenocarcinoma of the Rectum; Colon Cancer Liver Metastasis; Adenocarcinoma of the Colon
• Intervention / Treatment: Radiation: Y90 TARE; Diagnostic test: PET/CT; Diagnostic test: PET/MRI

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Constantinos T Sofocleous, MD, PhD; Phone Number: 212-639-3379; Email: sofoclec@mskcc.org
• Study Contact Backup: Name: Assen Kirov, PhD; Phone Number: 212-639-7126; Email: kirova@mskcc.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Constantinos T Sofocleous, MD, PhD; Phone Number: 212-639-3379

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The patients will be identified and recruited from the existing patient population in the Interventional Oncology/Radiology Service of the Department of Radiology at Memorial Sloan-Kettering Cancer Center (MSKCC). The patients will be presented with a study consent form and an explanation of any concerns they may have by the Principal Investigator or research team (i.e. Co-Investigators and consenting professionals).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Participants with colorectal cancer liver metastases; 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; 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.; Other Names: 90Y transarterial radioembolization; Diagnostic test: PET/CT; 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.; Diagnostic test: PET/MRI; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Constantinos T Sofocleous, MD, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2020
• Primary Completion (Estimated): December 7, 2026
• Study Completion (Estimated): December 7, 2026

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: December 9, 2020
• First Posted (Actual): December 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Memorial Sloan Kettering Cancer Center; Colon Cancer; transarterial radioembolization; Adenocarcinoma of the Colon; colorectal liver metastases; Y90 TARE; Colon Cancer Liver Metastasis; Adenocarcinoma of the Rectum; 20-355
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Rectal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Radiography; Image Interpretation, Computer-Assisted; Radiographic Image Enhancement; Image Enhancement; Photography; Tomography, X-Ray; Tomography, Emission-Computed; Radionuclide Imaging; Diagnostic Techniques, Radioisotope; Positron-Emission Tomography; Tomography, X-Ray Computed; Multimodal Imaging; Positron Emission Tomography Computed Tomography
• Other Study ID Numbers: 20-355

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No