RecruitingNCT04668872

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

80 participants

Start Date

Dec 7, 2020

Study Type

OBSERVATIONAL

Conditions

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

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

Min Age: 18 Years

Inclusion Criteria9

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 Criteria5

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.

Interventions

RADIATIONY90 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.

DIAGNOSTIC_TESTPET/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.

DIAGNOSTIC_TESTPET/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.