Collagen-targeted PET Imaging for Early Interstitial Lung Disease

Collagen-targeted PET Imaging for Early Interstitial Lung Disease (NCT05417776) is a Phase 2 interventional studying Interstitial Lung Disease, sponsored by Massachusetts General Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

The goal of this study is to investigate the ability of \[68Ga\]CBP8 to detect collagen deposition in early interstitial lung disease.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Interstitial Lung Disease and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form - 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. 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 willing to sign a consent form - 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 Should NOT Join This Trial: - 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) - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 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. 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. Exclusion criteria: * 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) * 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.

Treatments Being Tested

DRUG

[68Ga]CBP8

An injection of up to 350 MBq of \[68Ga\]CBP8 will be administered intravenously followed by PET-MRI.

DRUG

Dotarem

Dotarem will be administered during MRI portion of study.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Massachusetts General Hospital

Boston, Massachusetts, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05417776), the sponsor (Massachusetts General Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05417776 clinical trial studying?

The goal of this study is to investigate the ability of \[68Ga\]CBP8 to detect collagen deposition in early interstitial lung disease. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05417776?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05417776?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05417776. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05417776. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.