Collagen-targeted PET Imaging for Early Interstitial Lung Disease

NCT05417776 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 2022P001087
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Interstitial Lung Disease

Outcome Measures

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.

  24 months

Secondary Outcomes (3)

• Rate of MRI contrast clearance, Kwashout, in the lungs

  24 months

• Rate of MRI contrast arrival, Kwashin, in the lungs

  24 months

• Peak enhancement of MRI contrast in the lungs

  24 months

Study Arms (2)

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.

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.

Drug: [68Ga]CBP8; Drug: Dotarem

Interventions

[68Ga]CBP8 DRUG

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

First degree relatives of a family member with pulmonary fibrosis; Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD)

Dotarem DRUG

Dotarem will be administered during MRI portion of study.

Also known as: gadoterate meglumine

First degree relatives of a family member with pulmonary fibrosis; Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: collaborator
• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 31161770 BACKGROUND

• 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.

  PMID: 28381537 BACKGROUND

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

gadoterate meglumine

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Sydney B Montesi, MD

CONTACT

617-724-4030; sbmontesi@partners.org

Abimbola Akinniyi

CONTACT

781-513-0207; aakinniyi@mgb.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 14, 2022
• Study Start: September 28, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)