Interstitial Lung DiseasePhase 2NCT05417776
Collagen-targeted PET Imaging for Early Interstitial Lung Disease
A Phase 2 study testing [68Ga]CBP8 and Dotarem in people with Interstitial Lung Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this study is to investigate the ability of [68Ga]CBP8 to detect collagen deposition in early interstitial lung disease. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- [68Ga]CBP8 and Dotarem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2022to 1 Dec 2026
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Group 1: First degree relatives of a family member with pulmonary fibrosis (n=8)
- Age greater than 40 years
- Have the ability to give written informed consent
- First degree relative of a family member with pulmonary fibrosis
- No known history of interstitial lung disease
- No tobacco use within the prior 6 months.
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- Group 2: Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) (n=22)
- Age greater than 40 years
- Have the ability to give written informed consent
- ILAs or early ILD (defined by presence of reticular markings and / or traction bronchiectasis but absence of a definite UIP pattern)
- No tobacco use within the prior 6 months.
Who cannot join
- Electrical implants such as cardiac pacemaker or perfusion pump
- Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing
- Historical eGFR of less than 30 mL/min/1.73 m2
- Pregnant or breastfeeding (a negative quantitative serum hCG pregnancy test is required for females having child-bearing potential before the subject can participate)
- Claustrophobic reactions
- Research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months)
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- Unable to lie comfortably on a bed inside the MR-PET
- BMI > 33 (limit of the PET-MRI table)
- Determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening visit and/or during study procedures)
- Pneumonia or other acute respiratory illness within 6 weeks of study entry
- Parenchymal lung disease except for ILD/ILAs or emphysema
- Acute exacerbation of ILD within the prior 6 months
- VATS within the prior 6 months
- Prior radiation therapy to the thorax
- Known allergy to gadolinium.
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
Abimbola Akinniyi
Sydney Montesi, MD
About this study
The goal of this study is to investigate the ability of [68Ga]CBP8 to detect collagen deposition in early interstitial lung disease.
Read the detailed description
[68Ga]CBP8, is a PET imaging probe which selectively binds collagen type I. Collagen deposition is a pivotal event in the development of pulmonary fibrosis. [68Ga]CBP8 binds collagen with high affinity and has excellent pharmacological and pharmacokinetic profiles. [68Ga]CBP8 was shown in a mouse model to be effective for detecting lung fibrosis and response to treatment. In addition, [68Ga]CBP8 can detect increased collagen in the lungs of patients with idiopathic pulmonary fibrosis.
The goals of this study are:
- To determine whether collagen deposition as assessed by [68Ga]CBP8-PET MRI can detect increased collagen deposition in early interstitial lung disease and
- if the degree of [68Ga]CBP8 uptake predicts subsequent disease progression.
- Conditions
- Interstitial Lung Disease
- Being tested
- [68Ga]CBP8, Dotarem
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]CBP8Drug
An injection of up to 350 MBq of [68Ga]CBP8 will be administered intravenously followed by PET-MRI.
DotaremDrug
Also called gadoterate meglumine
Dotarem will be administered during MRI portion of study.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) | Experimental | Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) will receive [68Ga]CBP8 and undergo PET-MRI. Receives: Drug: [68Ga]CBP8; Drug: Dotarem |
| First degree relatives of a family member with pulmonary fibrosis | Experimental | First degree relatives of a family member with pulmonary fibrosis will receive [68Ga]CBP8 and undergo PET-MRI. Receives: Drug: [68Ga]CBP8; Drug: Dotarem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of uptake of [68Ga]CBP8
The degree of uptake of [68Ga]CBP8 in the lungs will be compared between groups and associations with disease severity and progression will be determined.
Measured: 24 months
Secondary outcomes (3)
Rate of MRI contrast clearance, Kwashout, in the lungs
Kwashout rates will be compared between groups and associations with disease severity, progression, and degree of uptake of [68Ga]CBP8 will be determined.
Measured: 24 months
Rate of MRI contrast arrival, Kwashin, in the lungs
Kwashin rates will be compared between groups and associations with disease severity, progression, and degree of uptake of [68Ga]CBP8 will be determined.
Measured: 24 months
Peak enhancement of MRI contrast in the lungs
Peak enhancement will be compared between groups and associations with disease severity, progression, and degree of uptake of [68Ga]CBP8 will be determined.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start28 Sep 2022
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Principal investigator, Sydney Butler Montesi, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417776
- Sponsor's protocol ID
- 2022P001087
- Status last verified
- Apr 2026
- First submitted
- 31 May 2022
- Last updated
- 20 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Montesi 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 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collagen-targeted PET Imaging for Early Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT05417776
- Acronym / sponsor ID
- 2022P001087
- Conditions
- Interstitial Lung Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 14 Jun 2022 (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 goal of this study is to investigate the ability of [68Ga]CBP8 to detect collagen deposition in early interstitial lung disease.
Detailed description
[68Ga]CBP8, is a PET imaging probe which selectively binds collagen type I. Collagen deposition is a pivotal event in the development of pulmonary fibrosis. [68Ga]CBP8 binds collagen with high affinity and has excellent pharmacological and pharmacokinetic profiles. [68Ga]CBP8 was shown in a mouse model to be effective for detecting lung fibrosis and response to treatment. In addition, [68Ga]CBP8 can detect increased collagen in the lungs of patients with idiopathic pulmonary fibrosis.
The goals of this study are:
- To determine whether collagen deposition as assessed by [68Ga]CBP8-PET MRI can detect increased collagen deposition in early interstitial lung disease and
- if the degree of [68Ga]CBP8 uptake predicts subsequent disease progression.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) | Experimental | Drug: [68Ga]CBP8, Drug: DotaremSubjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) will receive [68Ga]CBP8 and undergo PET-MRI. |
| First degree relatives of a family member with pulmonary fibrosis | Experimental | Drug: [68Ga]CBP8, Drug: DotaremFirst degree relatives of a family member with pulmonary fibrosis will receive [68Ga]CBP8 and undergo PET-MRI. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Group 1: First degree relatives of a family member with pulmonary fibrosis (n=8)
- Age greater than 40 years
- Have the ability to give written informed consent
- First degree relative of a family member with pulmonary fibrosis
- No known history of interstitial lung disease
Key exclusion criteria (15 listed)
- Electrical implants such as cardiac pacemaker or perfusion pump
- Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing
- Historical eGFR of less than 30 mL/min/1.73 m2
- Pregnant or breastfeeding (a negative quantitative serum hCG pregnancy test is required for females having child-bearing potential before the subject can participate)
- Claustrophobic reactions
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]CBP8An injection of up to 350 MBq of [68Ga]CBP8 will be administered intravenously followed by PET-MRI. | Drug | First degree relatives of a family member with pulmonary fibrosis, Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) |
| DotaremAlso: gadoterate meglumineDotarem will be administered during MRI portion of study. | Drug | First degree relatives of a family member with pulmonary fibrosis, Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) |
Primary outcome
Degree of uptake of [68Ga]CBP8
Time frame: 24 months
The degree of uptake of [68Ga]CBP8 in the lungs will be compared between groups and associations with disease severity and progression will be determined.
3 secondary outcomes
Rate of MRI contrast clearance, Kwashout, in the lungs
Time frame: 24 months
Rate of MRI contrast arrival, Kwashin, in the lungs
Time frame: 24 months
Peak enhancement of MRI contrast in the lungs
Time frame: 24 months
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 20 Apr 2026.
- 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.
- Individual participant dataSharing planned: No
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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.
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 Dotarem in people with Interstitial Lung Disease, run by Massachusetts General Hospital 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 11 inclusion and 15 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 20 Apr 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 B Montesi, MD (617-724-4030, sbmontesi@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of uptake of [68Ga]CBP8 (time frame: 24 months). 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 NCT05417776, which also lists 2 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 20 Apr 2026.