Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Colon Cancer, Colon Cancer Liver Metastasis, Colorectal Cancer, Liver Metastasis Colon Cancer
Conditions
Keywords
colorectal liver metastases, transarterial radioembolization, Y90 TARE, Colon Cancer Liver Metastasis, Colon Cancer, Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Colorectal Cancer, Memorial Sloan Kettering Cancer Center, 20-355
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.
Interventions
RADIATIONY90 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_TESTPET/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_TESTPET/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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTConstantinos T Sofocleous, MD, PhD
CONTACTAssen Kirov, PhD
PRINCIPAL_INVESTIGATORConstantinos T Sofocleous, MD, PhD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed