Biopsy After Radioembolization to Identify Changes in Tumor Cells From the Radiation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Y90 TARE, PET/CT, PET/MRI.
- Who it may be relevant to
- Registry conditions: Colon Cancer Liver Metastasis, Colon Cancer, Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Correlation of Histopathological Findings With Radiation Exposure Levels After Y90 Transarterial Radioembolization (TARE) of Hepatic Metastases: A Feasibility Study
Overview
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
- 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 surge - 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. - Diagnostic test 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.
Primary outcome measures
- Correlation of tissue necrosis and radiation-induced cell injury levels with delivered dose at 72 hours [Time frame: 72 hours after treatment]
- Correlation of tissue necrosis and radiation-induced cell injury levels with delivered dose at 14-21 days [Time frame: Between 14-21 days after treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Memorial Sloan Kettering Cancer Center — New York
Identifiers
NCT: NCT04668872 · 20-355