Clinical trial · Interventional
Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: Fluorine18 (18F) Fluoromisonidazole (FMISO) Imaging
Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: [18F]Fluoromisonidazole (FMISO) Imaging
NCT03303469CI-TRIAL-00050224terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): study was terminated due to poor enrollment
Summary
Brief summary (as posted)
\[18F\] FMISO Positron Emission Tomography (PET) to determine hypoxia in patients with HCC treated with TACE.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FMISO | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FMISO PET imaging post TACE and Stereotactic body radiation therapy (SBRT)
- description
- FMISO imaging at baseline, post-TACE and post-SBRT
- interventionNames
- Drug: FMISO
Primary outcomes (3)
- measure
- Quantitate HCC Tumor Hypoxia at Baseline Using FMISO Positron Emission Tomography (PET).
- timeFrame
- At baseline
- description
- Perform PET/CT imaging using FMISO at baseline to measure tumor hypoxia
- measure
- Measure Changes in HCC Tumor Hypoxia and Blood Flow After Trans-arterial Chemoembolization (TACE), Prior to Radiotherapy.
- timeFrame
- 1 month post-TACE procedures and prior to SBRT
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult (\> 18 years of age) patients with documented HCC tumor mass \>3cm, who are scheduled to undergo TACE with additional selective internal radiation therapy (SIRT) * The appropriate criteria for inclusion for this patient population are: * Biopsy or radiological diagnosis of HCC (defined as Organ Procurement and Transplantation Network (OPTN\*) Category 5 lesion either on CT or MRI) * Scheduled for TACE (using doxorubicin-eluting beads) + SBRT * Willingness to undergo PET/CT * Able to lie on the imaging table for up to 1 hour. * Able to provide signed informed consent. * Women with childbearing potential must have a negative urine Beta-Human Chorionic Gonadotropin (β-hCG) test day of procedure Exclusion Criteria: * Estimated life expectancy \<12 months or serious medical co-morbidities that would preclude definitive local therapy * Unable to lie on the imaging table * Age less than 18 years. * Pregnancy or lactation * Inability or unwillingness to provide informed consent. * Weight \>500 lbs (the weight limit of the tomograph gantry table)
References
Publications (0)
Data not yet available
No reference posted for this study.