Actively Recruiting
Correlation of Histopathological Findings With Radiation Exposure Levels After Y90 Transarterial Radioembolization of Liver Metastases from Colorectal Cancer: A Feasibility Study
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-12
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how radioembolization affects tumor cells in people with colorectal cancer that has spread to the liver. This research aims to improve the radioembolization procedure and understand how tumors respond to the treatment. The study focuses on patients with liver metastases deemed suitable for Y90 transarterial radioembolization (TARE). Participants will receive Y90 TARE as part of their standard clinical care, either targeting large liver areas or smaller segments depending on tumor spread. After the procedure, participants will undergo PET/CT or PET/MRI scans to measure radiation doses delivered to tumors and healthy liver tissue. The study includes biopsy sampling of tumors after treatment to assess radiation effects. During the study, researchers will collect biopsy samples and perform scans to evaluate tissue damage and radiation-induced injury at two time points: 72 hours and between 14 to 21 days after treatment. This helps correlate radiation doses with tumor and liver tissue response. Participants' health status and blood tests will be monitored to ensure safety throughout the study period.
CONDITIONS
Brief Title
Biopsy After Radioembolization to Identify Changes in Tumor Cells From the Radiation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status 0-2
- Histologically confirmed primary adenocarcinoma of the colon or rectum
- Liver metastases considered unresectable or not suitable for percutaneous ablation
- Existing biopsy tissue from target tumor within 42 days before treatment or clinical indication for biopsy at treatment time
- Adequate blood counts (WBC > 1.5 x 10^9/L, platelets > 50 x 10^9/L)
- Adequate kidney function (creatinine < 1.5 mg/dL)
- Total bilirubin level of 1.5 mg/dL or less
- For radiation segmentectomy patients: not suitable for surgery or thermal ablation
You will not qualify if you...
- Prior radiotherapy to the liver lesion or lobe planned for treatment
- Severe liver cirrhosis
- Severe portal hypertension
- Uncorrectable blood flow to the gastrointestinal tract or lung radiation dose above safe limits
- Uncontrolled or severe conditions that increase treatment risk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment event
Participants receive Y90 transarterial radioembolization (TARE) as standard of care to treat liver metastases from colorectal cancer.
1 visit (in-person)
Duration - Within 72 hours post-treatment
Following treatment, participants undergo PET/CT or PET/MRI scans to measure radiation dose delivered to tumors and liver tissue.
1 to 2 imaging visits (in-person)
Duration - Between 14 and 21 days post-treatment
Additional PET/CT or PET/MRI imaging to assess radiation effects between 14 and 21 days after treatment.
1 imaging visit (in-person)
Trial Site Locations
Total: 1 location
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
Research Team
C
Constantinos T Sofocleous, MD, PhD
A
Assen Kirov, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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