Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515178-28-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the use of multiparametric dynamic whole-body [68Ga]Ga-PSMA PET/CT imaging in newly diagnosed HCC patients or in HCC patients with recent suspicion of refractory, residual, or recurrent disease.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [68Ga]Ga-PSMA | Experimental | Dynamic whole-body [68Ga]Ga-PSMA acquisition to HCC patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [68Ga]Ga-PSMA-11 | Radiation | Dynamic whole-body [68Ga]Ga-PSMA acquisition to HCC patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance | Sensitivity of qualitative assessment of dynamic whole-body [68Ga]Ga- PSMA PET/CT using standard imaging methods, pathological data if available data or imaging follow-up of at least 6 months as gold standard in two populations of HCC patients: at the time of initial diagnosis or upon detection of suspected refractory, residual, or recurrent relapse. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Kinetic parameters | Patlak's parametric reconstruction, which estimates the 68 Gallium blood input function from the image, will be employed to extract the Ki absorption coefficient. | Baseline |
| Diagnostic performance of multiparametric image evaluation approach at the lesion level |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clément BAILLY | Contact | +33 2 40 08 41 36 | clement.bailly@chu-nantes.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HU Paris Nord APHP | Not yet recruiting | Clichy | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Sensitivity value of D-WB [68Ga]Ga-PSMA PET/CT and gold standard will be calculated and compared at the lesion level. |
| 6 months |
| Diagnostic performance of multiparametric image evaluation approach at the patient level | Sensitivity value of static [68Ga]Ga-PSMA PET/CT and Choline-PET will be calculated and compared. | 6 months |
| Diagnostic performance of multiparametric image evaluation approach at the patient level | Sensitivity value of dynamic [68Ga]Ga-PSMA PET/CT and Choline-PET will be calculated and compared. | 6 months |
| Acceptability in terms of comfort | Acceptability will be measured by a comfort scale from 1 (very uncomfortable) to 5 (very comfortable). | Baseline |
| Dynamic compared to static imaging | Target-to-background ratios (TBR) values were compared with Tumor normalized uptake values (SUV images) to evaluate lesions detection. | Baseline |
| CHU de Nantes | Recruiting | Nantes | France |
|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |