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Observational Study of Biopsy After Radioembolization for Colon Cancer Liver Metastasis

This study is looking at how a treatment called radioembolization (Y90 TARE) affects colon cancer that has spread to the liver. Researchers will collect biopsy samples from your tumor after you receive Y90 TARE, which is given as part of your usual care. They want to understand how the radiation changes the tumor cells. This research could help doctors improve how radioembolization is done and understand how tumors respond to it. To join, you must be at least 18 years old, have colon or rectal cancer that has spread to the liver and is not treatable by surgery or other local methods, and have existing tumor samples or a clinical need for a biopsy. The study aims to enroll 80 participants.

Study design
This is an observational study, meaning researchers will watch and collect information without assigning specific treatments. It plans to include 80 participants.
What's involved
You would receive Y90 TARE as part of your standard medical care. After treatment, you would have a PET/CT or PET/MRI scan, and biopsy samples would be collected from your tumor.
Compensation
Not stated in the trial record.
Follow-up
Researchers will look at your tissue samples at 72 hours and again between 14-21 days after treatment to see how the radiation affected the tumor.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04668872

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

Recruiting
Not specifiedAges 18+Observational
Memorial Sloan Kettering Cancer Center
~80 participants
Updated 2026-03-12 on ClinicalTrials.gov
What's tested:Y90 TAREPET/CTPET/MRI

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Correlation of tissue necrosis and radiation-induced cell injury levels with delivered dose at 72 hours
Measured over 72 hours after treatment
+1 more outcome measured

Conditions

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

Explore related trials

Colorectal Carcinoma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Constantinos T Sofocleous, MD, PhD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Constantinos T Sofocleous, MD, PhD
[email protected]
212-639-3379
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Correlation of tissue necrosis and radiation-induced cell injury levels with delivered dose at 72 hours72 hours after treatment

    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.

  • Correlation of tissue necrosis and radiation-induced cell injury levels with delivered dose at 14-21 daysBetween 14-21 days after treatment

    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.