Interstitial Lung DiseasePhase 2NCT07572383
Advanced Imaging to Assess the Effect of Immunosuppression on Progressive Fibrosis
A Phase 2 study testing [68Ga]CBP8 and Gadoterate Meglumine in people with Interstitial Lung Disease and Pulmonary Fibrosis, run by Peter Caravan at 1 site in United States.
Trial summary
The purpose of this study is to investigate how immunosuppression treatment affects measurements of active collagen deposition using [68Ga]CBP8 positron emission tomography (PET) and tissue injury using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) in individuals with non-idiopathic pulmonary fibrosis… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Interstitial Lung Disease, Pulmonary Fibrosis
- What is being tested?
- [68Ga]CBP8 and Gadoterate Meglumine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2026to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 with a diagnosis of chronic hypersensitivity pneumonitis, connective tissue-associated ILD (due to rheumatoid arthritis, systemic sclerosis, mixed connective tissue disease), or undifferentiated ILD.
- Starting immunosuppression treatment with mycophenolate mofetil, mycophenolate sodium, and / or prednisone for clinically indicated non-IPF ILD treatment.
- Pulmonary fibrosis, defined as honeycombing, traction bronchiectasis, or reticular opacities on high-resolution computed tomography (HRCT) performed within 1 year to or at Visit 1.
- Forced vital capacity (FVC) of >/= 45% and diffusing capacity of the lungs for carbon monoxide (DLCO) >/= 25% predicted on PFTs performed at Visit 1.
Who cannot join
- Current or prior exposure to FDA approved anti-fibrotic therapy.
- Extent of emphysema greater than extent of fibrosis.
- Pregnancy or plans to become pregnant at baseline or during follow-up.
- Contraindications to MRI.
- Contraindications to receiving gadolinium-based contrast agents.
- Research-related radiation exposure exceeds 50 millisievert (mSv) in the prior year.
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- Estimated glomerular filtration rate (eGFR) < 30 mL/min (only for individuals with a history of chronic kidney disease).
- Clinically significant pulmonary hypertension (PH) defined by use of pulmonary vasodilatory therapy.
- Respiratory infection within the prior 6 weeks.
- Smoking of any kind within the prior 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Sydney Montesi, 617 643 3260, cfromson@mgh.harvard.edu
Sydney Montesi, MD
About this study
Official title: Advanced Imaging to Assess the Effect of Immunosuppression on Progressive Lung Fibrosis in Participants With Non-Idiopathic Pulmonary Fibrosis Interstitial Lung Disease
The purpose of this study is to investigate how immunosuppression treatment affects measurements of active collagen deposition using [68Ga]CBP8 positron emission tomography (PET) and tissue injury using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) in individuals with non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD).
Read the detailed description
15 different subjects with non-IPF ILD starting immunosuppression treatment for their underlying ILD will be enrolled. Participants will undergo [68Ga]CBP8 PET and DCE-MRI prior to and 12 weeks after treatment initiation to determine the effects of immunosuppressive treatment on PET measurements of collagen deposition and selected DCE-MRI-derived measurements.
- Conditions
- Interstitial Lung Disease, Pulmonary Fibrosis
- Being tested
- [68Ga]CBP8, Gadoterate Meglumine
- Medical subject headings
- Lung Diseases, Interstitial, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]CBP8Drug
Participants will receive a single intravenous injection of up to 350 MBq of [68Ga]CBP8
Gadoterate MeglumineDrug
Participants will receive a single intravenous injection of 0.05 mmol/kg gadoterate meglumine during DCE-MRI
| Study group | Role | What they receive |
|---|---|---|
| Participants with Pulmonary Fibrosis | Experimental | Participants with non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD) will receive [68Ga]CBP8 and undergo PET combined with dynamic contrast-enhanced MRI prior to and 12 weeks after starting clinically-prescribed immunosuppression for treatment of non-IPF ILD Receives: Drug: [68Ga]CBP8; Drug: Gadoterate Meglumine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SUVmax25 over the entire lungs
Changes in lung collagen uptake will be measured using the PET probe [68]Ga-CBP8. Measurements will be made using the mean of the upper quartile of standardized uptake values (SUVmax25). Primary [68Ga]CBP8-PET outcome.
Measured: From baseline to 12 weeks
Change in the rate of contrast washin (kwashin) over the entire lungs
Changes in rate of contrast washin will be measured using dynamic-contrast enhanced MRI. Primary DCE-MRI outcomes.
Measured: From baseline to 12 weeks
Secondary outcomes (6)
Change in SUVmean over the entire lungs
Changes in lung collagen uptake will be measured using the PET probe [68]Ga-CBP8. Measurements will be made using the mean standardized uptake value (SUVmean).
Measured: From baseline to 12 weeks
Change in SUVmax over the entire lungs
Changes in lung collagen uptake will be measured using the PET probe [68]Ga-CBP8. Measurements will be made using the max standardized uptake value (SUVmax).
Measured: From baseline to 12 weeks
Change in peak enhancement over the entire lungs
Changes in peak enhancement will be measured using dynamic-contrast enhanced MRI
Measured: From baseline to 12 weeks
Change in time to peak over the entire lungs
Changes in time to peak will be measured using dynamic-contrast enhanced MRI
Measured: From baseline to 12 weeks
Change in the area under the curve at 60 seconds (AUC60) over the entire lungs
Changes in the area under the curve at 60 seconds will be measured using dynamic-contrast enhanced MRI
Measured: From baseline to 12 weeks
Change in the rate of contrast washout (kwashout) over the entire lungs
Changes in the rate of contrast washout will be measured using dynamic-contrast enhanced MRI.
Measured: From baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start14 May 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter Caravan
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Peter Caravan, Massachusetts General Hospital
- Investigators
- Sydney Montesi, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572383
- Sponsor's protocol ID
- 2024P001746Aim3
- Other IDs
- R01HL171240
- Status last verified
- Jul 2026
- First submitted
- 17 Apr 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Izquierdo-Garcia D, Desogere P, Fur ML, Shuvaev S, Zhou IY, Ramsay I, Lanuti M, Catalano OA, Catana C, Caravan P, Montesi SB. Biodistribution, Dosimetry, and Pharmacokinetics of 68Ga-CBP8: A Type I Collagen-Targeted PET Probe. J Nucl Med. 2023 May;64(5):775-781. doi: 10.2967/jnumed.122.264530. Epub 2022 Dec 8.
PubMed 37116909Montesi SB, Izquierdo-Garcia D, Desogere P, Abston E, Liang LL, Digumarthy S, Seethamraju R, Lanuti M, Caravan P, Catana C. Type I Collagen-targeted Positron Emission Tomography Imaging in Idiopathic Pulmonary Fibrosis: First-in-Human Studies. Am J Respir Crit Care Med. 2019 Jul 15;200(2):258-261. doi: 10.1164/rccm.201903-0503LE. No abstract available.
PubMed 31161770Desogere P, Tapias LF, Hariri LP, Rotile NJ, Rietz TA, Probst CK, Blasi F, Day H, Mino-Kenudson M, Weinreb P, Violette SM, Fuchs BC, Tager AM, Lanuti M, Caravan P. Type I collagen-targeted PET probe for pulmonary fibrosis detection and staging in preclinical models. Sci Transl Med. 2017 Apr 5;9(384):eaaf4696. doi: 10.1126/scitranslmed.aaf4696.
PubMed 28381537
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Imaging to Assess the Effect of Immunosuppression on Progressive Lung Fibrosis in Participants With Non-Idiopathic Pulmonary Fibrosis Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT07572383
- Acronym / sponsor ID
- 2024P001746Aim3
- Conditions
- Interstitial Lung Disease, Pulmonary Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Peter CaravanUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 14 May 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate how immunosuppression treatment affects measurements of active collagen deposition using [68Ga]CBP8 positron emission tomography (PET) and tissue injury using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) in individuals with non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD).
Detailed description
15 different subjects with non-IPF ILD starting immunosuppression treatment for their underlying ILD will be enrolled. Participants will undergo [68Ga]CBP8 PET and DCE-MRI prior to and 12 weeks after treatment initiation to determine the effects of immunosuppressive treatment on PET measurements of collagen deposition and selected DCE-MRI-derived measurements.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Pulmonary Fibrosis | Experimental | Drug: [68Ga]CBP8, Drug: Gadoterate MeglumineParticipants with non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD) will receive [68Ga]CBP8 and undergo PET combined with dynamic contrast-enhanced MRI prior to and 12 weeks after starting clinically-prescribed immunosuppression for treatment of non-IPF ILD |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80 with a diagnosis of chronic hypersensitivity pneumonitis, connective tissue-associated ILD (due to rheumatoid arthritis, systemic sclerosis, mixed connective tissue disease), or undifferentiated ILD.
- Starting immunosuppression treatment with mycophenolate mofetil, mycophenolate sodium, and / or prednisone for clinically indicated non-IPF ILD treatment.
- Pulmonary fibrosis, defined as honeycombing, traction bronchiectasis, or reticular opacities on high-resolution computed tomography (HRCT) performed within 1 year to or at Visit 1.
- Forced vital capacity (FVC) of >/= 45% and diffusing capacity of the lungs for carbon monoxide (DLCO) >/= 25% predicted on PFTs performed at Visit 1.
Key exclusion criteria (10 listed)
- Current or prior exposure to FDA approved anti-fibrotic therapy.
- Extent of emphysema greater than extent of fibrosis.
- Pregnancy or plans to become pregnant at baseline or during follow-up.
- Contraindications to MRI.
- Contraindications to receiving gadolinium-based contrast agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]CBP8Participants will receive a single intravenous injection of up to 350 MBq of [68Ga]CBP8 | Drug | Participants with Pulmonary Fibrosis |
| Gadoterate MeglumineParticipants will receive a single intravenous injection of 0.05 mmol/kg gadoterate meglumine during DCE-MRI | Drug | Participants with Pulmonary Fibrosis |
Primary outcome
Change in SUVmax25 over the entire lungs
Time frame: From baseline to 12 weeks
Changes in lung collagen uptake will be measured using the PET probe [68]Ga-CBP8. Measurements will be made using the mean of the upper quartile of standardized uptake values (SUVmax25). Primary [68Ga]CBP8-PET outcome.
Change in the rate of contrast washin (kwashin) over the entire lungs
Time frame: From baseline to 12 weeks
Changes in rate of contrast washin will be measured using dynamic-contrast enhanced MRI. Primary DCE-MRI outcomes.
6 secondary outcomes
Change in SUVmean over the entire lungs
Time frame: From baseline to 12 weeks
Change in SUVmax over the entire lungs
Time frame: From baseline to 12 weeks
Change in peak enhancement over the entire lungs
Time frame: From baseline to 12 weeks
Change in time to peak over the entire lungs
Time frame: From baseline to 12 weeks
Change in the area under the curve at 60 seconds (AUC60) over the entire lungs
Time frame: From baseline to 12 weeks
Change in the rate of contrast washout (kwashout) over the entire lungs
Time frame: From baseline to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Background: PubMed 37116909Izquierdo-Garcia D, Desogere P, Fur ML, Shuvaev S, Zhou IY, Ramsay I, Lanuti M, Catalano OA, Catana C, Caravan P, Montesi SB. Biodistribution, Dosimetry, and Pharmacokinetics of 68Ga-CBP8: A Type I Collagen-Targeted PET Probe. J Nucl Med. 2023 May;64(5):775-781. doi: 10.2967/jnumed.122.264530. Epub 2022 Dec 8.
- Background: PubMed 31161770Montesi SB, Izquierdo-Garcia D, Desogere P, Abston E, Liang LL, Digumarthy S, Seethamraju R, Lanuti M, Caravan P, Catana C. Type I Collagen-targeted Positron Emission Tomography Imaging in Idiopathic Pulmonary Fibrosis: First-in-Human Studies. Am J Respir Crit Care Med. 2019 Jul 15;200(2):258-261. doi: 10.1164/rccm.201903-0503LE. No abstract available.
- Background: PubMed 28381537Desogere P, Tapias LF, Hariri LP, Rotile NJ, Rietz TA, Probst CK, Blasi F, Day H, Mino-Kenudson M, Weinreb P, Violette SM, Fuchs BC, Tager AM, Lanuti M, Caravan P. Type I collagen-targeted PET probe for pulmonary fibrosis detection and staging in preclinical models. Sci Transl Med. 2017 Apr 5;9(384):eaaf4696. doi: 10.1126/scitranslmed.aaf4696.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sydney Montesi, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [68Ga]CBP8 and Gadoterate Meglumine in people with Interstitial Lung Disease and Pulmonary Fibrosis, run by Peter Caravan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sydney Montesi, MD (617 724 4030, sbmontesi@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SUVmax25 over the entire lungs (time frame: From baseline to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07572383, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.