Collagen-targeted PET Imaging for Early Interstitial Lung Disease

NCT ID: NCT05417776

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-28
• Study Completion Date: 2026-04-01

Brief Summary

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:

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.

Conditions

Interstitial Lung Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

[68Ga]CBP8

Intervention Type: DRUG

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

Dotarem

Intervention Type: DRUG

Dotarem will be administered during MRI portion of study.

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.

Group Type: EXPERIMENTAL

[68Ga]CBP8

Intervention Type: DRUG

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

Dotarem

Intervention Type: DRUG

Dotarem will be administered during MRI portion of study.

Interventions

[68Ga]CBP8

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

Intervention Type: DRUG

Dotarem

Dotarem will be administered during MRI portion of study.

Intervention Type: DRUG

Other Intervention Names

gadoterate meglumine

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sydney Butler Montesi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sydney B Montesi, MD

Role: CONTACT

sbmontesi@partners.org

617-724-4030

Abimbola Akinniyi

Role: CONTACT

aakinniyi@mgb.org

781-513-0207

Facility Contacts

Abimbola Akinniyi

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 31161770 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28381537 (View on PubMed)

Other Identifiers

2022P001087

Identifier Type: -

Identifier Source: org_study_id