Not provided
Not provided
Not provided
Not provided
Not provided
study was terminated due to poor enrollment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
[18F] FMISO Positron Emission Tomography (PET) to determine hypoxia in patients with HCC treated with TACE.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMISO PET imaging post TACE and Stereotactic body radiation therapy (SBRT) | Experimental | FMISO imaging at baseline, post-TACE and post-SBRT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMISO | Drug | FMISO PET/CT imaging at baseline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quantitate HCC Tumor Hypoxia at Baseline Using FMISO Positron Emission Tomography (PET). | Perform PET/CT imaging using FMISO at baseline to measure tumor hypoxia | At baseline |
| 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 | 1 month post-TACE procedures and prior to SBRT |
| Measure Changes in Treated HCC Tumor Hypoxia Following TACE and Radiotherapy | Perform PET/CT imaging using FMISO post-SBRT to determine tumor hypoxia | 1 month post-SBRT |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janis P O'Malley, M.D. | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Advanced Imaging Facility | Birmingham | Alabama | 35294 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 30, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| FMISO | Drug | FMISO PET/CT post TACE |
|
| FMISO | Drug | FMISO PET/CT post SBRT |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | We were unable to perform the statistical analysis due to insufficient data collection. | Posted | At baseline |
|
| |||||||||||||||||||
| 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 | We were unable to perform the statistical analysis due to insufficient data collection. | Posted | 1 month post-TACE procedures and prior to SBRT |
|
| |||||||||||||||||||
| Primary | Measure Changes in Treated HCC Tumor Hypoxia Following TACE and Radiotherapy | Perform PET/CT imaging using FMISO post-SBRT to determine tumor hypoxia | We were unable to perform the statistical analysis due to insufficient data collection. | Posted | 1 month post-SBRT |
|
|
Between 4 to 6 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 3 | 0 | 3 | 0 | 3 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janis O'Malley | The University of Alabama at Birmingham | 205-934-6504 | jomalley@uabmc.edu |
| Feb 15, 2021 |
| Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C031843 | fluoromisonidazole |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|