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NCT Number: NCT05417776

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.

Recruiting

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Abimbola Akinniyi

CONTACT

Sydney Montesi, MD

PRINCIPAL_INVESTIGATOR

About this study

[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:

  • To determine whether collagen deposition as assessed by [68Ga]CBP8-PET MRI can detect increased collagen deposition in early interstitial lung disease and
  • if the degree of [68Ga]CBP8 uptake predicts subsequent disease progression.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[68Ga]CBP8

Drug

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

DOTAREM

Drug

Dotarem will be administered during MRI portion of study.

Other names: gadoterate meglumine

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abimbola Akinniyi

CONTACT

[email protected]

781-513-0207

Sydney B Montesi, MD

CONTACT

[email protected]

617-724-4030

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Boehringer Ingelheim

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 14, 2022
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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