Clinical trial NCT05417776: Collagen-targeted PET Imaging for Early Interstitial Lung Disease
Official title: Collagen-targeted PET Imaging for Early Interstitial Lung Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Interstitial Lung Disease
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2022-06-14
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Degree of uptake of [68Ga]CBP8
timeFrame: 24 months
Secondary outcomes:
measure: Rate of MRI contrast clearance, Kwashout, in the lungs
timeFrame: 24 months
measure: Rate of MRI contrast arrival, Kwashin, in the lungs
timeFrame: 24 months
measure: Peak enhancement of MRI contrast in the lungs
timeFrame: 24 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
citation: 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.
citation: 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.