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

Recruiting now

Conditions studied: Colon Cancer Liver Metastasis, Colon Cancer, Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Liver Metastasis Colon Cancer, Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT04668872

Run by

Memorial Sloan Kettering Cancer Center

People needed

80

Starts

2020-12-07

Expected to finish

2026-12-07

Last updated by the study team

2026-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Additional inclusion criteria for patients, undergoing 90Y radiation segmentectomy:
• A. patients not amenable to surgery or thermal ablation

You may not qualify if…

• Study exclusion criteria will be similar to general TARE exclusion criteria, which are as follows:
• 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.

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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