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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04668872

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer Liver Metastasis Colon Cancer Adenocarcinoma of the Colon Adenocarcinoma of the Rectum Liver Metastasis Colon Cancer Colorectal Cancer	Radiation: Y90 TARE Diagnostic Test: PET/CT Diagnostic Test: PET/MRI

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Correlation of Histopathological Findings With Radiation Exposure Levels After Y90 Transarterial Radioembolization (TARE) of Hepatic Metastases: A Feasibility Study

Actual Study Start Date :

Dec 7, 2020

Anticipated Primary Completion Date :

Dec 7, 2022

Anticipated Study Completion Date :

Dec 7, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Radiation: 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. Other Names: 90Y transarterial radioembolization Diagnostic Test: 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. Diagnostic Test: 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.

Arm

Intervention/Treatment

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.

Radiation: 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.

Other Names:

90Y transarterial radioembolization

Diagnostic Test: 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.

Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

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

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.