Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DCE-MRI scans, Gadobutrol · 1 trial · 1 indication
Interstitial volume (ve) was measured by DCE-MRI. ve for total lung, left lung, right lung, left lung apical, left lung basal, right lung apical, right lung basal has been presented. Session 1 values were considered as Baseline values.
Exchange rate (Ktrans) was measured by DCE-MRI. Ktrans for total lung, left lung, right lung, left lung apical, left lung basal, right lung apical, right lung basal has been presented. Session 1 values were considered as Baseline values.
Interstitial volume (ve) was measured by DCE-MRI. ve for total lung, left lung, right lung, left lung apical, left lung basal, right lung apical, right lung basal before and following exercise has been presented.
Exchange rate (Ktrans) was measured by DCE-MRI. Ktrans for total lung, left lung, right lung, left lung apical, left lung basal, right lung apical, right lung basal before and following exercise has been presented.
Interstitial volume (ve) was measured by DCE-MRI. Three participants underwent 3 DCE-MRI scans. The data has been presented for individual participant in each session. The data presented below is only for total lung.
Exchange rate (Ktrans) was measured by DCE-MRI. Three participants underwent 3 DCE-MRI scans. The data has been presented for individual participant in each session. The data presented below is only for total lung.
| Arm | Type | Description |
|---|---|---|
| Healthy volunteers | EXPERIMENTAL | All subjects will undergo MRI scanning conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 Tesla (T) system. |
| Heart failure patients | EXPERIMENTAL | All subjects will undergo DCE-MRI scanning conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 T system. |
| Acute decompensated heart failure | EXPERIMENTAL | All subjects will undergo DCE-MRI scanning conducted by experienced radiographers and radiologists in the nominated scanning sites, using a 1.5 T system |
| Name | Type | Description |
|---|---|---|
| DCE-MRI scans | PROCEDURE | Subjects will be placed supine in the scanner and will be prepared for intravenous contrast agent administration. The contrast agent is administered using a power injector before imaging. |
| Gadobutrol | OTHER | Gadobutrol at a dose less than or equal to 0.1 millimoles per kilogram (mmol/kg) will be given intravenously as a bolus using a power injector. |
Inclusion Criteria: * Male or females over 18 years of age at the time of signing the informed consent. * Body weight \>=50 kilogram (kg) and Body Mass Index (BMI) within the range 18.0-40.0 kilogram/square meter (kg/m\^2) (inclusive). * Able to understand and comply with protocol requirements, ins...
Gadobutrol is a contrast agent used in a Phase 1 method validation study for evaluating novel treatments that limit pulmonary oedema in congestive heart failure. The study involved 41 participants, including healthy volunteers, and was conducted in the United Kingdom. It was a controlled, randomized trial, though not double-blind.
Gadobutrol is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company conducted a Phase 1 clinical trial to validate methods for assessing treatments aimed at reducing pulmonary oedema in patients with congestive heart failure.
Gadobutrol is in Phase 1 clinical development. The Phase 1 trial, identified as NCT02135861, has been completed. This trial was designed as a method validation study for evaluating novel treatments that limit pulmonary oedema in cardiac failure, and it enrolled 41 participants.
Gadobutrol has one completed Phase 1 clinical trial registered under NCT02135861, titled "A Method Validation Study for Evaluation of Novel Treatments Limiting Pulmonary Oedema in Cardiac Failure." The trial enrolled 41 participants with congestive heart failure and healthy volunteers, and it took place in the United Kingdom.
Gadobutrol is an investigational agent in clinical development for use in congestive heart failure. It is not approved for this indication. The Phase 1 trial has been completed, but the drug remains in early-stage development, and no approval status has been established.