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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04668872
Other study ID # 20-355
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 7, 2020
Est. completion date December 7, 2024

Study information

Verified date January 2024
Source Memorial Sloan Kettering Cancer Center
Contact Constantinos T Sofocleous, MD, PhD
Phone 212-639-3379
Email sofoclec@mskcc.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 7, 2024
Est. primary completion date December 7, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

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.
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.
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.

Locations

Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation of tissue necrosis and radiation-induced cell injury levels with delivered dose at 72 hours 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. 72 hours after treatment
Primary Correlation of tissue necrosis and radiation-induced cell injury levels with delivered dose at 14-21 days 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. Between 14-21 days after treatment
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