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Study of [68Ga]CBP8 for Lung Conditions

This study is testing a new imaging agent called [68Ga]CBP8. It's designed to help doctors see collagen deposition, which is a key part of conditions like pulmonary fibrosis (scarring of the lungs) and lung cancer. Researchers want to see if [68Ga]CBP8 is safe and how well it can detect this collagen in healthy people, and those with lung cancer or pulmonary fibrosis. You would receive a small amount of [68Ga]CBP8 and then undergo a PET scan (a type of imaging test). The main goal is to see if this imaging agent can detect increased collagen in pulmonary fibrosis within two hours of administration. The study aims to enroll up to 100 participants, but the current recruitment status is unclear.

Study design
This interventional study plans to enroll up to 100 participants, including healthy individuals, and patients with lung cancer or idiopathic pulmonary fibrosis. It is not specified if it is randomized or blinded.
What's involved
You would receive an injection of [68Ga]CBP8 and then undergo a PET imaging scan. The study does not specify the number of visits or the total duration of participation.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at two hours after administration of [68Ga]CBP8. Further follow-up beyond this is not specified.

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NCT03535545

Preliminary Evaluation of [68Ga]CBP8 in Healthy Individuals, Lung Cancer, and Idiopathic Pulmonary Fibrosis Patients

Recruiting
PHASE1Ages 18–80InterventionalDiagnostic
Massachusetts General Hospital
~100 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:[68Ga]CBP8PET Imaging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ability to detect increased collagen deposition in pulmonary fibrosis.
Measured over Two hours

Conditions

Pulmonary Fibrosis
Lung Cancer

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Chronic Lung Allograft DysfunctionInterstitial Lung DiseaseLung Non-Small Cell CarcinomaPneumonitisPulmonary Fibrosis

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Sydney B Montesi, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Sydney B Montesi, MD
[email protected]
617 724 4030
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.
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
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
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

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

What this trial measures

  • Ability to detect increased collagen deposition in pulmonary fibrosis.Two hours

    Probe lung uptake will be measured in pulmonary fibrosis subjects and compared to lung uptake in healthy volunteers. We expect greater uptake in the lungs of IPF patients and patients with other types of ILD with a fibrotic component.