Biopsy After Radioembolization to Identify Changes in Tumor Cells From the Radiation
Part of paid clinical trials in New York, New York.
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Study ID
- NCT04668872
- Status
- Recruiting
Conditions
- Adenocarcinoma of the Colon
- Adenocarcinoma of the Rectum
- Colon Cancer
- Colon Cancer Liver Metastasis
- Colorectal Cancer
- Liver Metastasis Colon Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Y90 TARE — RADIATIONY90 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.
- PET/CT — DIAGNOSTIC_TESTFollowing 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 — DIAGNOSTIC_TESTFollowing 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.
Study Details
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.
Key Dates
- Start date
- Dec 7, 2020
- Status verified
- Mar 2026
- Primary completion
- Dec 7, 2026
- Completion
- Dec 7, 2026
Study Design
- Enrollment
- 80 participants (estimated)
Arms
- Arm: Participants with colorectal cancer liver metastasesThe 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.
Primary Outcome Measure
Correlation of tissue necrosis and radiation-induced cell injury levels with delivered dose at 72 hours [ Time Frame: 72 hours after treatment ]
Central Contacts
- Constantinos T Sofocleous, MD, PhD212-639-3379
- Assen Kirov, PhD212-639-7126
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Constantinos T Sofocleous, MD, PhD 212-639-3379 |
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