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RecruitingNCT05417776Updated Apr 20, 2026

Collagen-targeted PET Imaging for Early Interstitial Lung Disease

A Phase 2 interventional study of [68Ga]CBP8 and Dotarem in Interstitial Lung Disease, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by Massachusetts General Hospital · Phase 2, Interventional, and Diagnostic

From the registry’s dates

  • Started Sep 2022; still recruiting 4 years later.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
40 Years and older
Sex
All
01

Study summary

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:

  1. To determine whether collagen deposition as assessed by [68Ga]CBP8-PET MRI can detect increased collagen deposition in early interstitial lung disease and
  2. if the degree of [68Ga]CBP8 uptake predicts subsequent disease progression.
02

Conditions studied

  • Interstitial Lung Disease
03

In context

Lung Diseases, Interstitial

646 studies on the registry are indexed under Lung Diseases, Interstitial; 237 are open to participants now.

This study's planned enrollment of 30 is below the median of 54 across 355 interventional studies indexed under Lung Diseases, Interstitial.

Browse Lung Diseases, Interstitial studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD)

    Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) will receive \[68Ga\]CBP8 and undergo PET-MRI.

    Drug: [68Ga]CBP8 · Drug: Dotarem

  • Experimental
    First degree relatives of a family member with pulmonary fibrosis

    First degree relatives of a family member with pulmonary fibrosis will receive \[68Ga\]CBP8 and undergo PET-MRI.

    Drug: [68Ga]CBP8 · Drug: Dotarem

Interventions

  • Drug[68Ga]CBP8

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

  • DrugDotarem

    Dotarem will be administered during MRI portion of study.

    Also known as: gadoterate meglumine

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 months

Secondary outcomes

  1. 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.

    Time frame: 24 months

  2. 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.

    Time frame: 24 months

  3. 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.

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
    • Abimbola Akinniyi · Contact
    • Sydney Montesi, MD · Principal investigator
    Recruiting
08

References and documents

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 31161770 ↗
  • Desogere 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05417776
Lead sponsor
Massachusetts General Hospital
Collaborators
Boehringer Ingelheim
Responsible party
Sydney Butler Montesi (Principal Investigator, Massachusetts General Hospital) — Principal investigator
First posted
Jun 14, 2022
Start date
Sep 28, 2022
Primary completion
Oct 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Apr 20, 2026

Study contacts

Sydney B Montesi, MD
Contact
sbmontesi@partners.org
617-724-4030
Abimbola Akinniyi
Contact
aakinniyi@mgb.org
781-513-0207

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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