Actively Recruiting

Age: 18Years +
All Genders
ID04668872

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Y90 TARE Treatment

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)

Diagnostic Evaluation

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)

Diagnostic Evaluation

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

Loading map...

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

Similar Trials

A Phase 1/2a Study of the Safety, Tolerability, and Prelimin...

Castration-Resistant Prostate Cancer (CRPC)

Actively Recruiting

4 locations

Evaluation of Diagnostic Value of 18F-T2 PET/ CT Imaging for...

Clear Cell Renal Cell Cancer (ccRCC)

Actively Recruiting

1 location

A Phase 1/2a Study Utilizing 64Cu-LNTH-1363S (64Cu Radiolabe...

Metastatic Sarcoma

Actively Recruiting

5 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here