Clinical trial · Interventional
PET-CT in Determining the Radioembolization Dose Delivered to Patients With Liver Metastasis, Primary Liver Cancer, or Biliary Cancer
Intrinsic Dosimetry for Radioembolization Utilizing PET-CT Imaging Data: A Prospective Registry Study
NCT02088775CI-TRIAL-00116738completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This clinical trial studies positron emission tomography (PET)-computed tomography (CT) in determining the radiation dose delivered with radioactive spheres to patients with liver metastasis or primary liver or biliary cancer. Comparing results of diagnostic procedures dose before and after delivery of radioactive spheres to the liver may help determine radioembolization dose and plan the best treatment for liver metastasis or primary liver or biliary cancer.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Primary Hepatocellular Carcinoma | Adult Hepatocellular Carcinoma | ALIAS | 0.90 |
| Advanced Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Metastatic Extrahepatic Bile Duct Cancer | Malignant Extrahepatic Bile Duct Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Recurrent Extrahepatic Bile Duct Cancer | Malignant Extrahepatic Bile Duct Neoplasm | CURATED_BROADER | 0.78 |
| Stage D Adult Primary Liver Cancer (BCLC) | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT Scan | Procedure | — | UNRESOLVED |
| hepatic artery embolization | Procedure | — | UNRESOLVED |
| PET scan | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic: PET scan - CT scan
- description
- Patients undergo PET-CT scan before and after standard radioembolization on day 0. A subset of patients undergo PET-CT scan on day 1, 24 hours after the day 0 post-treatment PET-CT.
- interventionNames
- Procedure: PET scan
- Procedure: CT Scan
- Procedure: hepatic artery embolization
Primary outcomes (2)
- measure
- Radiation dose to 70% of the tumor volume, evaluated using PET-CT
- timeFrame
- Up to day 1
- description
- Standard summary measures such as means, medians, ranges, and standard deviations will be used to characterize the dosages received by tumor and other tissue. The relationship between radiation dose and local control will be determined using regression models with Generalized Estimating Equations (GEE) to account for within-patient correlation. Logistic regression will be used to adjust for potentially confounding factors such as tumor volume, primary histology, and SIR-Spheres versus Therasphere intervention.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have liver-dominant or liver-only metastatic disease from any primary histology; patients with primary hepatocellular or biliary cancer are also eligible * Patients must be clinical candidates for radioembolization with either SIR-spheres or TheraSphere due to metastatic or primary malignancies of the liver * Women of child bearing potential must have a negative serum pregnancy test no more than 72 hours prior to registration * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2 * Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of medical information * Complete blood count (CBC) and chemistry panel (CMP) no greater than 4 weeks prior to visit 1 * Diagnostic imaging of the abdomen utilizing either CT with contrast, magnetic resonance imaging (MRI), or PET/CT no greater than 4 weeks prior to visit 1 Exclusion Criteria: * Patients not undergoing radioembolization to the liver * Women of childbearing potential (WOCBP) and men who refuse to comply with appropriate contraception * Women who are either pregnant or breast feeding
References
Publications (0)
Data not yet available
No reference posted for this study.