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Trial record 1 of 1 for:    NCT05417776
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Collagen-targeted PET Imaging for Early Interstitial Lung Disease

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ClinicalTrials.gov Identifier: NCT05417776
Recruitment Status : Recruiting
First Posted : June 14, 2022
Last Update Posted : January 26, 2024
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Sydney Butler Montesi, Massachusetts General Hospital

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

Condition or disease Intervention/treatment Phase
Interstitial Lung Disease Drug: [68Ga]CBP8 Drug: Dotarem Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Collagen-targeted PET Imaging for Early Interstitial Lung Disease
Actual Study Start Date : September 28, 2022
Estimated Primary Completion Date : April 1, 2024
Estimated Study Completion Date : April 1, 2024

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Arms and Interventions
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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 Name: 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 Name: gadoterate meglumine


Outcome Measures
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Primary Outcome Measures :
  1. Degree of uptake of [68Ga]CBP8 [ Time Frame: 24 months ]
    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.


Secondary Outcome Measures :
  1. Rate of MRI contrast clearance, Kwashout, in the lungs [ Time Frame: 24 months ]
    Kwashout rates will be compared between groups and associations with disease severity, progression, and degree of uptake of [68Ga]CBP8 will be determined.

  2. Rate of MRI contrast arrival, Kwashin, in the lungs [ Time Frame: 24 months ]
    Kwashin rates will be compared between groups and associations with disease severity, progression, and degree of uptake of [68Ga]CBP8 will be determined.

  3. Peak enhancement of MRI contrast in the lungs [ Time Frame: 24 months ]
    Peak enhancement will be compared between groups and associations with disease severity, progression, and degree of uptake of [68Ga]CBP8 will be determined.


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05417776


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

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Abimbola Akinniyi         
Principal Investigator: Sydney Montesi, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Boehringer Ingelheim
More Information
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Publications:

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Responsible Party: Sydney Butler Montesi, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT05417776    
Other Study ID Numbers: 2022P001087
First Posted: June 14, 2022    Key Record Dates
Last Update Posted: January 26, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases
Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
 Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action