Hepatocellular Carcinoma
Conditions
Brief summary
\[18F\] FMISO Positron Emission Tomography (PET) to determine hypoxia in patients with HCC treated with TACE.
Detailed description
This Phase II study will investigate the utility of \[18F\] FMISO in patients with hepatocellular carcinoma (HCC). This trial is designed to test the hypothesis that PET determined \[18F\]FMISO uptake will indicate tumor hypoxia in patients with HCC treated with trans-arterial chemo-embolization (TACE). We anticipate that \[18F\] FMISO PET/CT will advance our understanding of the role of hypoxia in HCC prior to treatment and that this knowledge will help design newer combination therapeutic trials for better treatment outcomes. \[18F\] FMISO PET/CT provides three parameters, tissue hypoxic volume (HV), maximum tissue to blood uptake ratio (T:Bmax) and tumor blood flow. Both pre-and post-therapy images will be examined to investigate changes in these parameters during the course of TACE treatment.
Interventions
DRUGFMISO
FMISO PET/CT imaging at baseline
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitate HCC Tumor Hypoxia at Baseline Using FMISO Positron Emission Tomography (PET). | At baseline | Perform PET/CT imaging using FMISO at baseline to measure tumor hypoxia |
| Measure Changes in HCC Tumor Hypoxia and Blood Flow After Trans-arterial Chemoembolization (TACE), Prior to Radiotherapy. | 1 month post-TACE procedures and prior to SBRT | Perform PET/CT imaging using FMISO post-TACE and prior to Stereotactic body radiation therapy (SBRT) to determine tumor hypoxia |
| Measure Changes in Treated HCC Tumor Hypoxia Following TACE and Radiotherapy | 1 month post-SBRT | Perform PET/CT imaging using FMISO post-SBRT to determine tumor hypoxia |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FMISO PET Imaging Post TACE and SBRT FMISO imaging at baseline, post-TACE and post-SBRT
FMISO: FMISO PET/CT imaging at baseline
FMISO: FMISO PET/CT post TACE
FMISO: FMISO PET/CT post SBRT | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | FMISO PET Imaging Post TACE and SBRT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Measure Changes in HCC Tumor Hypoxia and Blood Flow After Trans-arterial Chemoembolization (TACE), Prior to Radiotherapy.
Perform PET/CT imaging using FMISO post-TACE and prior to Stereotactic body radiation therapy (SBRT) to determine tumor hypoxia
Time frame: 1 month post-TACE procedures and prior to SBRT
Population: We were unable to perform the statistical analysis due to insufficient data collection.
Primary
Measure Changes in Treated HCC Tumor Hypoxia Following TACE and Radiotherapy
Perform PET/CT imaging using FMISO post-SBRT to determine tumor hypoxia
Time frame: 1 month post-SBRT
Population: We were unable to perform the statistical analysis due to insufficient data collection.
Primary
Quantitate HCC Tumor Hypoxia at Baseline Using FMISO Positron Emission Tomography (PET).
Perform PET/CT imaging using FMISO at baseline to measure tumor hypoxia
Time frame: At baseline
Population: We were unable to perform the statistical analysis due to insufficient data collection.