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

Recruiting

• Conditions: Adenocarcinoma of the Rectum; Colon Cancer Liver Metastasis; Liver Metastasis Colon Cancer; Colon Cancer; Adenocarcinoma of the Colon; Colorectal Cancer
• Interventions: Radiation: Y90 TARE; Diagnostic Test: PET/CT; Diagnostic Test: PET/MRI

• Registration Number: NCT04668872
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-07
• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-12-07
• Study Completion: 2025-12-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Additional inclusion criteria for patients, undergoing 90Y radiation segmentectomy:

A. patients not amenable to surgery or thermal ablation

Exclusion Criteria

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with colorectal cancer liver metastases	Y90 TARE	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.
Participants with colorectal cancer liver metastases	PET/MRI	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.
Participants with colorectal cancer liver metastases	PET/CT	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.

Primary Outcome Measures

Name	Time	Method
Correlation of tissue necrosis and radiation-induced cell injury levels with delivered dose at 72 hours	72 hours after treatment	Determine the feasibility of correlating tissue necrosis and radiation-induced cell injury levels with delivered dose within the target colorectal cancer liver metastases (CLM) and the uninvolved liver parenchyma.
Correlation of tissue necrosis and radiation-induced cell injury levels with delivered dose at 14-21 days	Between 14-21 days after treatment	Determine the feasibility of correlating tissue necrosis and radiation-induced cell injury levels with delivered dose within the target colorectal cancer liver metastases (CLM) and the uninvolved liver parenchyma.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States