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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

Baseline, 3, 6, and 12 months following initiation of IPF therapy

Results posted on

2026-01-02

Participant Flow

Participant milestones

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

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

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=228 Participants
Sex: Female, Male
Female
10 Participants
n=228 Participants
Sex: Female, Male
Male
15 Participants
n=228 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=228 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
24 Participants
n=228 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=228 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=228 Participants
Race (NIH/OMB)
Asian
1 Participants
n=228 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=228 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=228 Participants
Race (NIH/OMB)
White
23 Participants
n=228 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=228 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=228 Participants
Region of Enrollment
United States
25 Participants
n=228 Participants

PRIMARY outcome

Timeframe: Baseline, 3, 6, and 12 months following initiation of IPF therapy

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.

Outcome measures

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 therapy

Population: 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

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 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
Change in Pulmonary Function Following Initiation of IPF Therapy - Forced Vital Capacity (FVC)
Baseline to 12 months
0.190 liters
Standard Deviation 0.256

SECONDARY outcome

Timeframe: Baseline, 3, 6, and 12 months following initiation of IPF therapy

Population: 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

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 events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert M. Tighe, MD

Duke University

Phone: 919-684-4894

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place