Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Laboratory ISTCT UMR6030 CNRS of Caen (France) | UNKNOWN |
| Centre de Recherche du Centre Hospitalier de l'Université de Montréal | OTHER |
Not provided
Not provided
Not provided
Not provided
To predict response of HCC to TACE using dynamic oxygen-enhanced (dOE)-MRI for assessment of the level of tumor hypoxia before and after treatment.
This will be a single-center, prospective, study to evaluate dOE-MRI in patients undergoing TACE for HCC according to the clinical standard of care. This protocol has already been approved by the local research ethics committee. Adult patients with HCC >25mm undergoing TACE are enrolled. Imaging will be performed on a 3T whole-body MRI, dOE-MRI will be acquired with a free-breathing T1-weighted dynamic acquisition with respiratory motion-resolved compressed sensing reconstruction (XD-GRASP). Tumor hypoxia will be assessed by measuring changes in the longitudinal relaxation rate (∆R1) from baseline (21% O2) and during a hyperoxic respiratory challenge (FiO2 100%). Tumor response will be assessed by mRECIST and LI-RADS Treatment Response Assessment v2024. Descriptive statistics for the level of ∆R1 pre- and post- treatment will be presented using means and standard deviations. Progression-free survival and overall survival will be evaluated by using the Cox proportional hazard model and Kaplan-Meier method. Receiver operating characteristic (ROC) curve analysis at one year will be performed and the optimal cutoff threshold of ∆R1 will be calculated using Youden's index.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCC patients | Experimental | a diagnostic test (MRI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI contrast-enhancing agents | Diagnostic Test | MRI before and after treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypoxic levels of hepatocellular carcinoma according to R1 variations during an oxygen challenge on MRI scans before treatment. | T1 mapping is performed on an MRI during an oxygen challenge. The mean R1 value (equal to 1/T1) is calculated under ambient air conditions and after 15 minutes of inhaling 100% oxygen. The mean delta R1 values (i.e. the changes during the oxygen challenge, such as the difference in R1 values when exposed to 21% and 100% oxygen) are reported for each tumour measuring over 25 mm in each patient. The correlation between the delta R1 values and tumour response will be analysed. | Oxygen-enhanced MRI will be performed 4-6 weeks before treatment. Patients will be followed up 2 years after treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoxic level of HCC according to R1 variations during an oxygen challenge on MRI scans after treatment | After treatment, T1 mapping is performed on an MRI during an oxygen challenge. The mean R1 value (equal to 1/T1) is calculated under ambient air conditions and after 15 minutes of inhaling 100% oxygen. The mean delta R1 values (i.e., the changes during the oxygen challenge, such as the difference in R1 values between exposures to 21% and 100% oxygen) are reported for each targeted tumour in each patient. The correlation between the delta R1 values after treatment and tumour response will be analysed. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRCHUM | Montreal | Quebec | H2X0A9 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D000860 | Hypoxia |
| 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
| Oxygen-enhanced MRI is performed 4-6 weeks after treatment. Patients are followed up 2 years after treatment. |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |