Clinical trial · Observational
Biopsy After Radioembolization to Identify Changes in Tumor Cells From the Radiation
Correlation of Histopathological Findings With Radiation Exposure Levels After Y90 Transarterial Radioembolization (TARE) of Hepatic Metastases: A Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Colon | Colon Adenocarcinoma | ALIAS | 0.90 |
| Adenocarcinoma of the Rectum | Rectal Adenocarcinoma | ALIAS | 0.90 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colon Cancer Liver Metastasis | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Liver Metastasis Colon Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET/CT | Diagnostic Test | — | UNRESOLVED |
| PET/MRI | Diagnostic Test | — | UNRESOLVED |
| Y90 TARE | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants with colorectal cancer liver metastases
- description
- 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.
- interventionNames
- Radiation: Y90 TARE
- Diagnostic Test: PET/CT
- Diagnostic Test: PET/MRI
Primary outcomes (2)
- measure
- Correlation of tissue necrosis and radiation-induced cell injury levels with delivered dose at 72 hours
- timeFrame
- 72 hours after treatment
- description
- 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.
- measure
- Correlation of tissue necrosis and radiation-induced cell injury levels with delivered dose at 14-21 days
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available