Collagen-targeted PET Imaging for Early Interstitial Lung Disease

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

Study Overview

• Status: Recruiting
• Conditions: Interstitial Lung Disease
• Intervention / Treatment: Drug: [68Ga]CBP8; Drug: Dotarem

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sydney B Montesi, MD; Phone Number: 617-724-4030; Email: sbmontesi@partners.org
• Study Contact Backup: Name: Abimbola Akinniyi; Phone Number: 781-513-0207; Email: aakinniyi@mgb.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Principal Investigator: Sydney Montesi, MD
      • Contact: Abimbola Akinniyi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.; Other Names: gadoterate meglumine
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; 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.; Other Names: gadoterate meglumine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	24 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Boehringer Ingelheim

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; gadoterate meglumine
• Other Study ID Numbers: 2022P001087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No