Trial Outcomes & Findings for Genentech Xenon MRI Idiopathic Pulmonary Fibrosis (NCT NCT04071769)
NCT ID: NCT04071769
Last Updated: 2026-01-02
Results Overview
RBC:barrier ratio will be determined using 129 Xenon MRI. The RBC:barrier ratio is a key metric that quantifies the efficiency of gas exchange, specifically the balance between red blood cell uptake and alveolar-capillary barrier function by showing how well oxygen gets from the air sacs to the blood. A low ratio often indicates impaired gas transfer, reflecting conditions where either RBC function or the barrier's permeability is compromised.
ACTIVE_NOT_RECRUITING
PHASE2
34 participants
Baseline, 3, 6, and 12 months following initiation of IPF therapy
2026-01-02
Participant Flow
Participant milestones
| Measure |
Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF)
Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments
Hyperpolarized 129 Xenon Gas Comparing Idiopathic Pulmonary Fibrosis (IPF) Treatment: Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF)
Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments
Hyperpolarized 129 Xenon Gas Comparing Idiopathic Pulmonary Fibrosis (IPF) Treatment: Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
8
|
Baseline Characteristics
Genentech Xenon MRI Idiopathic Pulmonary Fibrosis
Baseline characteristics by cohort
| Measure |
Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF)
n=25 Participants
Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments
Hyperpolarized 129 Xenon Gas Comparing Idiopathic Pulmonary Fibrosis (IPF) Treatment: Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments
|
|---|---|
|
Age, Continuous
|
72.56 years
STANDARD_DEVIATION 6.37 • n=9 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3, 6, and 12 months following initiation of IPF therapyRBC:barrier ratio will be determined using 129 Xenon MRI. The RBC:barrier ratio is a key metric that quantifies the efficiency of gas exchange, specifically the balance between red blood cell uptake and alveolar-capillary barrier function by showing how well oxygen gets from the air sacs to the blood. A low ratio often indicates impaired gas transfer, reflecting conditions where either RBC function or the barrier's permeability is compromised.
Outcome measures
| Measure |
Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF)
n=25 Participants
Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments
Hyperpolarized 129 Xenon Gas Comparing Idiopathic Pulmonary Fibrosis (IPF) Treatment: Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments
|
|---|---|
|
Efficiency of Gas Exchange as Measured by the Red Blood Cell (RBC):Barrier Ratio Following Initiation of IPF Therapy
Baseline
|
0.250 RBC:barrier ratio
Standard Deviation 0.062
|
|
Efficiency of Gas Exchange as Measured by the Red Blood Cell (RBC):Barrier Ratio Following Initiation of IPF Therapy
3 months
|
0.237 RBC:barrier ratio
Standard Deviation 0.071
|
|
Efficiency of Gas Exchange as Measured by the Red Blood Cell (RBC):Barrier Ratio Following Initiation of IPF Therapy
6 months
|
0.246 RBC:barrier ratio
Standard Deviation 0.073
|
|
Efficiency of Gas Exchange as Measured by the Red Blood Cell (RBC):Barrier Ratio Following Initiation of IPF Therapy
12 months
|
0.256 RBC:barrier ratio
Standard Deviation 0.063
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, and 12 months following initiation of IPF therapyPopulation: Two participants only completed the baseline visit.
FVC, or Forced Vital Capacity, is a lung function test that measures the maximum amount of air a person can forcefully exhale from their lungs after taking a deep breath. This test is performed using a spirometer and the results are used by healthcare providers to help diagnose and monitor pulmonary diseases like asthma, emphysema, or restrictive lung conditions.
Outcome measures
| Measure |
Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF)
n=23 Participants
Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments
Hyperpolarized 129 Xenon Gas Comparing Idiopathic Pulmonary Fibrosis (IPF) Treatment: Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments
|
|---|---|
|
Change in Pulmonary Function Following Initiation of IPF Therapy - Forced Vital Capacity (FVC)
Baseline to 12 months
|
0.190 liters
Standard Deviation 0.256
|
|
Change in Pulmonary Function Following Initiation of IPF Therapy - Forced Vital Capacity (FVC)
Baseline to 3 months
|
0.073 liters
Standard Deviation 0.244
|
|
Change in Pulmonary Function Following Initiation of IPF Therapy - Forced Vital Capacity (FVC)
Baseline to 6 months
|
0.063 liters
Standard Deviation 0.229
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, and 12 months following initiation of IPF therapyPopulation: Participants with data collected at both timepoints used for analysis. Two participants only completed the baseline visit.
The DLCO, or Diffusing Capacity of the Lung for Carbon Monoxide, is a pulmonary function test that measures how well oxygen transfers from the lungs to the blood by measuring how much carbon monoxide diffuses from the lungs into the bloodstream. Performed by inhaling a special gas mixture and holding the breath, the DLCO test assesses the gas exchange function of the lungs.
Outcome measures
| Measure |
Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF)
n=22 Participants
Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments
Hyperpolarized 129 Xenon Gas Comparing Idiopathic Pulmonary Fibrosis (IPF) Treatment: Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments
|
|---|---|
|
Change in Pulmonary Function Following Initiation of IPF Therapy - Diffusion Capacity for Carbon Monoxide (DLCO)
Baseline to 3 months
|
0.026 mL/min/mmHg
Standard Deviation 1.961
|
|
Change in Pulmonary Function Following Initiation of IPF Therapy - Diffusion Capacity for Carbon Monoxide (DLCO)
Baseline to 6 months
|
-0.029 mL/min/mmHg
Standard Deviation 2.530
|
|
Change in Pulmonary Function Following Initiation of IPF Therapy - Diffusion Capacity for Carbon Monoxide (DLCO)
Baseline to 12 months
|
-0.306 mL/min/mmHg
Standard Deviation 1.846
|
Adverse Events
Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place