Biopsy After Radioembolization to Identify Changes in Tumor Cells From the Radiation
NCT ID: NCT04668872
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2020-12-07
2026-12-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants with colorectal cancer liver metastases
The study population is represented by patients with colorectal cancer liver metastases that have been deemed clinically appropriate/eligible to receive Y90 TARE for the management of their liver metastases.
Y90 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.
PET/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.
PET/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.
Interventions
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Y90 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.
PET/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.
PET/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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Constantinos T Sofocleous, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Constantinos T Sofocleous, MD, PhD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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20-355
Identifier Type: -
Identifier Source: org_study_id
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