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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Y90 TARE — RADIATION
    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.
  • PET/CT — DIAGNOSTIC_TEST
    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 — DIAGNOSTIC_TEST
    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.

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 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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Constantinos T Sofocleous, MD, PhD
212-639-3379

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