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The planned number of enrolled patients was not reached.
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The main objective is to evaluate the value of dynamic contrast-enhanced Magnetic Resonance Imaging (DCE-MRI) in prediction of response of patients with hepatocellular carcinoma (HCC) to treatment with Sorafenib assessed by mRECIST.
One of the secondary objectives was to evaluate the correlation between DCE-MRI perfusion parameters at baseline and:
Three DCE-MRI examinations were done during the study:
DCE-MRI perfusion parameters were assessed by a centralized radiologist at baseline (corresponding to the day of enrolment and initiation of Sorafenib treatment), week 1 and week 2.
According to mRECIST criteria, HCC lesions were evaluated on computed tomography images by two on-site radiologists at the time of enrolment and 8 weeks later (2 months). OS, PFS and TTP were calculated from survival and tumor progression data recorded one year after initiation of the sorafenib treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gadoterate meglumine | Experimental | there is one single arm of patients (no comparative arm) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadoterate meglumine | Drug | Gadoterate meglumine was administered at a dose of 0.1 mmol/kg (0.2 mL/kg) using a power injector, in an intravenous bolus at a rate of 3 mL/sec. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Coefficient Between DCE-MRI Perfusion Parameters and the Response of Target Lesions to Sorafenib | To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, Wash-in, Washout) at baseline, week 1 and week 2, and the response of target lesions to sorafenib.
The response of target lesions was assessed by mRECIST at 2 months after initiation of treatment (sorafenib). The correlation analyses were done using Pearson or Spearman correlation coefficient. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Overall Survival | To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, wash-in, washout) at baseline and overall survival. The overall survival was calculated from the patient's survival status recorded one year after initiation of the sorafenib treatment. The correlation analyses were done using Pearson or Spearman correlation coefficient. |
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| Name | Affiliation | Role |
|---|---|---|
| Jeong Min Lee, Ph.D | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guerbet Korea | Seoul | Gangnam Gu | 135-920 | South Korea |
It will be decided after study completion.
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Despite several extensions of the recruitment period, the planned number of enrolled patients was still not reached after 2 years and the study was prematurely discontinued.
A total of 37 patients were enrolled in four study sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gadoterate Meglumine | All patients who received gadoterate meglumine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gadoterate Meglumine | All patients who received gadoterate meglumine. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Correlation Coefficient Between DCE-MRI Perfusion Parameters and the Response of Target Lesions to Sorafenib | To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, Wash-in, Washout) at baseline, week 1 and week 2, and the response of target lesions to sorafenib.
The response of target lesions was assessed by mRECIST at 2 months after initiation of treatment (sorafenib). The correlation analyses were done using Pearson or Spearman correlation coefficient. | A total of 26 target lesions were identified in the 15 patients of the full analysis set (patients with available data for the primary criteria). One lesion was not assessed at baseline, week 1 and week 2 for all parameters and one lesion was not assessed at baseline and week 1 for Ktrans, ve and kep. | Posted | Number | correlation coefficient | 3 months | Target lesions | Target lesions |
3 months (from the informed consent signature to 2 months after initiation of the sorafenib treatment)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gadoterate Meglumine | All patients who received gadoterate meglumine. | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
The small number of patients included and analyzed was a major limitation to interpret the efficacy results, inducing high variability in DCE-MRI perfusion parameters, OS, PFS and TTP values.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corinne Dubourdieu, Head of Clinical Projects | Guerbet | +33145915000 | corinne.dubourdieu@guerbet.com |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C072417 | gadoterate meglumine |
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|
| 1 year |
| Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Progression Free Survival | To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, wash-in, washout) at baseline and progression free survival. The progression free survival was calculated from the patient's survival status and tumor progression status recorded one year after initiation of the sorafenib treatment. The correlation analyses were done using Pearson or Spearman correlation coefficient. | 1 year |
| Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Time to Progression | To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, wash-in, washout) at baseline and time to progression. The time to progression was calculated from the patient's survival status and tumor progression status recorded one year after initiation of the sorafenib treatment. The correlation analyses were done using Pearson or Spearman correlation coefficient. | 1 year |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Baseline | DCE-MRI perfusion parameters assessed at baseline (initiation of the sorafenib treatment) |
| OG001 | Week 1 | DCE-MRI perfusion parameters assessed one week after initiation of the sorafenib treatment |
| OG002 | Week 2 | DCE-MRI perfusion parameters assessed two weeks after initiation of the sorafenib treatment |
|
|
| Secondary | Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Overall Survival | To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, wash-in, washout) at baseline and overall survival. The overall survival was calculated from the patient's survival status recorded one year after initiation of the sorafenib treatment. The correlation analyses were done using Pearson or Spearman correlation coefficient. | Among the 15 patients of the full analysis set (26 target lesions), one patient was lost to follow-up. Consequently, 14 patients had data for overall survival (23 target lesions). One lesion was not assessed for Ktrans, ve and kep. | Posted | Number | correlation coefficient | 1 year | Target lesions | Target lesions |
|
|
|
| Secondary | Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Progression Free Survival | To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, wash-in, washout) at baseline and progression free survival. The progression free survival was calculated from the patient's survival status and tumor progression status recorded one year after initiation of the sorafenib treatment. The correlation analyses were done using Pearson or Spearman correlation coefficient. | Among the 15 patients of the full analysis set (26 target lesions), 13 had data for progression free survival (22 target lesions). One lesion was not assessed for Ktrans, ve and kep. | Posted | Number | correlation coefficient | 1 year | Target lesions | Target lesions |
|
|
|
| Secondary | Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Time to Progression | To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, wash-in, washout) at baseline and time to progression. The time to progression was calculated from the patient's survival status and tumor progression status recorded one year after initiation of the sorafenib treatment. The correlation analyses were done using Pearson or Spearman correlation coefficient. | Among the 15 patients of the full analysis set (26 target lesions), 4 patients had data for time to progression (7 target lesions). | Posted | Number | correlation coefficient | 1 year | Target lesions | Target lesions |
|
|
|
| 31 |
| 7 |
| 31 |
| 29 |
| 31 |
| Tumor necrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
|
| Gastric varices haemorrhage | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Chronic gastritis | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Portal hypertensive gastropathy | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Palmoplantar keratoderma | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| Penile erythema | Reproductive system and breast disorders | MedDRA (17.1) | Systematic Assessment |
|
| Penile oedema | Reproductive system and breast disorders | MedDRA (17.1) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
|
|
|
|
|
|
| AUC (mean) |
|
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| ve (mean) |
|
|
| kep (mean) |
|
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| T1 (mean) |
|
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| Wash-in (mean) |
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| Washout (mean) |
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| AUC (mean) |
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| ve (mean) |
|
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| kep (mean) |
|
|
| T1 (mean) |
|
|
| Wash-in (mean) |
|
|
| Washout (mean) |
|
|
| Title | Measurements |
|---|---|
|
| kep (mean) |
|
| T1 (mean) |
|
| Wash-in (mean) |
|
| Washout (mean) |
|