RecruitingNCT04668872

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

80 participants

Start Date

Dec 7, 2020

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting tumor biopsies from patients with colorectal cancer that has spread to the liver, after a targeted radiation treatment called radioembolization (where tiny radioactive beads are delivered directly into the tumor's blood supply). Researchers want to understand how the radiation changes the cancer cells, which could help develop better follow-up treatments. **You may be eligible if you:** - Are 18 years of age or older - Have been diagnosed with colorectal cancer that has spread to the liver - Have liver metastases that cannot be surgically removed or treated with ablation - Have had a prior biopsy of the tumor, or need one now - Have adequate blood counts and kidney and liver function - Are in good enough health to participate (ECOG performance status 0–2) **You may NOT be eligible if you:** - Have conditions that make biopsy unsafe - Do not have enough liver function to tolerate the procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONY90 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.

DIAGNOSTIC_TESTPET/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_TESTPET/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.


Locations(1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

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NCT04668872


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