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Biopsy After Radioembolization to Identify Changes in Tumor Cells From the Radiation | Clinical Trials | Clareo Health

RECRUITING

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

NCT04668872•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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.

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

December 7, 2020

Primary Completion Date

December 7, 2026

Completion Date

December 7, 2026

Last Updated

March 12, 2026

Enrollment

ESTIMATED participants

Conditions

Colon Cancer Liver MetastasisColon CancerAdenocarcinoma of the ColonAdenocarcinoma of the RectumLiver Metastasis Colon CancerColorectal Cancer

Interventions

Y90 TARE

RADIATION

PET/CT

DIAGNOSTIC_TEST

PET/MRI

DIAGNOSTIC_TEST

Contacts

Constantinos T Sofocleous, MD, PhD

CONTACT

212-639-3379 sofoclec@mskcc.org

Assen Kirov, PhD

CONTACT

212-639-7126 kirova@mskcc.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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