Clinical trial · Interventional
[18F]FMISO PET/CT After Transcatheter Arterial Embolization in Imaging Tumors in Patients With Liver Cancer
Assessment of Treatment-Induced Tissue Hypoxia After Transcatheter Arterial Embolization of Hepatocellular Carcinoma: A Feasibility Study With [18F]FMISO PET/CT
- 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 how well 18F-fluoromisonidazole (\[18F\]FMISO) positron emission tomography (PET)/computed tomography (CT) works after transcatheter arterial embolization in imaging tumors in patients with liver cancer. Transcatheter arterial embolization blocks blood flow to tumor cells by inserting tiny foreign particles into an artery near the tumor. \[18F\]FMISO is a type of radioimaging agent that binds to large molecules in tumor cells that have a low level of oxygen, and the radiation given off by \[18F\]FMISO is picked up by a PET scan and this may help researchers learn whether changes occur in the tumors after treatment, which can help decide how well the treatment worked earlier than is currently possible
Conditions
Conditions (2)
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 Liver Carcinoma | Adult Liver Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cirrhosis | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-Fluoromisonidazole | Drug | — | UNRESOLVED |
| Arterial Embolization | Procedure | — | UNRESOLVED |
| Computed Tomography | Diagnostic Test | — | UNRESOLVED |
| Positron Emission Tomography | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (18F-fluoromisonidazole, PET/CT, embolization)
- description
- Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole IV and undergo PET/CT scans 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment.
- interventionNames
- Drug: 18F-Fluoromisonidazole
- Procedure: Arterial Embolization
- Diagnostic Test: Computed Tomography
- Diagnostic Test: Positron Emission Tomography
Primary outcomes (1)
- measure
- Post-treatment Maximum Standardized Uptake Value (SUVmax) in Tumor and Normal Tissue
- timeFrame
- 24 hours
- description
- All participants undergo transcatheter arterial embolization (TACE) and 18F-fluoromisonidazole (18F-FMISO) positron emission tomography (PET)/computed tomography (CT) scans were conducted. Maximum standardized uptake value (SUVmax) were determined at the tumor lesion and in normal tissue, represented by liver. The variability of 18F-FMISO uptake in hepatocellular carcinoma (HCC) tumors post-TACE was assessed as the ratio of the SUVmax as observed in the tumor vs liver (tumor-to-liver ratio, TLR). The outcome is reported as the mean TLR, with standard deviation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 * Histopathologic or imaging and clinical features of tumor(s) diagnostic for hepatocellular carcinoma with at least one tumor \>= 1.5 cm; imaging features diagnostic for hepatocellular carcinoma will be defined as Liver Imaging Reporting and Data System (LIRADS) 4 or greater * Total bilirubin \< 3.0 * Child Pugh A or B * Tumor amenable to transcatheter arterial embolization * Able to provide informed consent Exclusion Criteria: * Uncontrolled large ascites * Main or segmental portal vein thrombosis * Locoregional treatment of hepatocellular carcinoma within the prior 3 months or chemotherapy within the previous 3 months * Inability or contraindication to undergo transcatheter arterial embolization * Inability to lay flat for at least 2 consecutive hours * Severe acute illness * Uncontrolled chronic illness such as hypertension, diabetes, or heart failure * Contraindication to CT or MRI contrast * Pregnancy
References
Publications (1)
- DERIVEDShah RP, Laeseke PF, Shin LK, Chin FT, Kothary N, Segall GM. Limitations of Fluorine 18 Fluoromisonidazole in Assessing Treatment-induced Tissue Hypoxia after Transcatheter Arterial Embolization of Hepatocellular Carcinoma: A Prospective Pilot Study. Radiol Imaging Cancer. 2022 May;4(3):e210094. doi: 10.1148/rycan.210094. PMID 35485937