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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04668872
• Other study ID #: 20-355
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Colon
• Adenocarcinoma of the Rectum
• Colon Cancer
• Colon Cancer Liver Metastasis
• Colonic Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms
• Liver Metastasis Colon Cancer
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary

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

External Links

•   Memorial Sloan Kettering Cancer Center