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

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Contact Information
Primary
Constantinos T Sofocleous, MD, PhD
sofoclec@mskcc.org
212-639-3379
Backup
Assen Kirov, PhD
kirova@mskcc.org
212-639-7126
Time Frame
Start Date: 2020-12-07
Estimated Completion Date: 2026-12-07
Participants
Target number of participants: 80
Treatments
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.
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov