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Collagen-targeted PET Imaging for Early Interstitial Lung Disease

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05417776
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Massachusetts General Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Interstitial Lung Disease
Additional Details

[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.

Arms & Interventions

Arms

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.

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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Site Contact

Abimbola Akinniyi

sbmontesi@partners.org

617-724-4030