Recruiting
Phase 1

\[68Ga\]CBP8

Sponsor:

Massachusetts General Hospital

Code:

NCT03535545

Conditions

Pulmonary Fibrosis

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

[68Ga]CBP8

PET Imaging

Study Details

Brief summary:

The goal of this study is to investigate the safety of \[68Ga\]CBP8 and its efficacy to detect collagen deposition in pulmonary fibrosis.

Conditions

Pulmonary Fibrosis

Lung Cancer

Study ID

NCT03535545

Start date

Aug 1, 2018

Status verified date

Feb, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Healthy Individuals

Healthy volunteers will receive \[68Ga\]CBP8 and undergo PET imaging.

experimental: Lung Cancer Subjects

Lung cancer patients will receive \[68Ga\]CBP8 and undergo PET imaging.

experimental: Pulmonary Fibrosis Subjects

Idiopathic pulmonary fibrosis patients or patients with other types of interstitial lung disease with a fibrotic component will receive \[68Ga\]CBP8 and undergo PET imaging.

experimental: Subjects with chronic lung allograft dysfunction (CLAD)

Subjects with chronic lung allograft dysfunction (CLAD) will receive \[68Ga\]CBP8 and undergo PET imaging.

experimental: Subjects with immune-checkpoint-inhibitor (ICI) pneumonitis

Subjects with immune-checkpoint-inhibitor (ICI) pneumonitis will receive \[68Ga\]CBP8 and undergo PET imaging.

Interventions

[68Ga]CBP8

Up to 15 mCi of \[68Ga\]CBP8 will be administered to each subject.

PET Imaging

All subjects will undergo PET imaging after administration of \[68Ga\]CBP8.

Primary outcome measure

  • Ability to detect increased collagen deposition in pulmonary fibrosis. [ Time Frame: Two hours ]

Central Contacts and Locations

Central contacts

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator:

Sydney Montesi, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • PET Imaging
  • Molecular Imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-02-27.