Evaluating a new imaging probe for lung conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and efficacy of [68Ga]CBP8, a gallium-68 labeled PET imaging probe that targets collagen type I, in detecting collagen deposition in pulmonary fibrosis and lung cancer. The trial includes healthy individuals, lung cancer patients, and those with idiopathic pulmonary fibrosis (IPF). It aims to assess the probe's safety, whole body distribution, and its ability to accurately identify radiation-induced fibrosis in lung cancer patients, as well as predict disease progression in IPF patients. The study will involve up to 100 subjects and will utilize advanced imaging techniques to correlate findings with existing diagnostic methods.

Why it matters

Who can join: the full rules

Inclusion Criteria: Total enrollment for all groups will not exceed 100 subjects.

* Group 1: Healthy subjects
* Age greater than 18 years
* Be deemed healthy at screening visit as determined by the physician investigator or nurse practitioner, based on the following assessments at Screening: physical examination, medical history, and vital signs
* Have the ability to give written informed consent;
* No known history of pulmonary disease (excluding pulmonary nodules);
* No prior history of tobacco use.

Group 2: Lung cancer subjects

* Eligible patients will be those harboring locally advanced clinical stage IIIA NSCLC who are deemed candidates for multi-modality therapy, i.e. concurrent chemotherapy and radiation followed by pulmonary resection.
* Age greater than 18 years
* Have the ability to give written informed consent.
* No tobacco use within the prior 6 months.

Group 3: Subjects with pulmonary fibrosis

* IPF (with a UIP or probable UIP pattern); or other forms of interstitial lung disease (ILD), including CTD-ILD, with a fibrotic component as noted by the presence of reticular markings and / or traction bronchiectasis and / or honeycombing on CT;
* Age: 40-80 years old;
* Have the ability to give written informed consent;
* No tobacco use within the prior 6 months

Group 4: Subjects with chronic lung allograft dysfunction (CLAD)

* Status post lung transplantation
* Clinical diagnosis of chronic lung allograft dysfunction
* Age: 40-80 years old;
* Have the ability to give written informed consent;
* No tobacco use within the prior 6 months

Group 5: Subjects with immune-checkpoint-inhibitor (ICI) pneumonitis

* CT findings with ground glass opacities / consolidation or fibrotic changes with new onset during or within 3 months of receipt of ICI therapy
* Age greater than 18 years
* Have the ability to give written informed consent
* 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;
* eGFR of less than 30 mL/min/1.73 m2 within the past 90 days for group 4 subjects; history of chronic kidney disease for subjects in groups 1-3 and 5;
* 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 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);
* Known history of pulmonary disease (except for pulmonary fibrosis in the study group, ICI pneumonitis in the study group, or CLAD in the study group), recent pneumonia or respiratory tract infections within 6 weeks of enrollment, prior radiation therapy to the thorax (except for the lung cancer patients in aim 2);
* Pneumonia or other acute respiratory illness within 6 weeks of study entry (except for pulmonary fibrosis), pneumonia defined with elevated WBC, fever, infiltrate on CXR and need for antibiotics

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Sydney B Montesi, MD — Massachusetts General Hospital
• Study coordinator: Sydney B Montesi, MD
• Email: sbmontesi@partners.org
• Phone: 617 724 4030

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.