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
1 other identifier
observational
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 7, 2020
CompletedFirst Submitted
Initial submission to the registry
December 9, 2020
CompletedFirst Posted
Study publicly available on registry
December 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 7, 2026
March 12, 2026
March 1, 2026
6 years
December 9, 2020
March 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
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.
Interventions
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.
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.
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.
Eligibility Criteria
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).
You may qualify if:
- 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
- A. patients not amenable to surgery or thermal ablation
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Constantinos T Sofocleous, MD, PhD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2020
First Posted
December 16, 2020
Study Start
December 7, 2020
Primary Completion (Estimated)
December 7, 2026
Study Completion (Estimated)
December 7, 2026
Last Updated
March 12, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
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.