Actively Recruiting
Preliminary Evaluation of [68Ga]CBP8 in Healthy Individuals, Lung Cancer, and Idiopathic Pulmonary Fibrosis Patients
Led by Massachusetts General Hospital · Updated on 2026-02-27
100
Participants Needed
1
Research Sites
465 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this study is to investigate the safety of \[68Ga\]CBP8 and its efficacy to detect collagen deposition in pulmonary fibrosis.
CONDITIONS
Official Title
Preliminary Evaluation of [68Ga]CBP8 in Healthy Individuals, Lung Cancer, and Idiopathic Pulmonary Fibrosis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Enrollment will not exceed 100 subjects across all groups
- For healthy subjects: age over 18 years, healthy based on physical exam and medical history, no pulmonary disease (except nodules), no prior tobacco use
- For lung cancer patients: age over 18 years, locally advanced stage IIIA NSCLC, candidates for chemotherapy, radiation, and surgery, no tobacco use within 6 months
- For pulmonary fibrosis patients: age 40 to 80 years, diagnosis of IPF with UIP or probable UIP pattern or other fibrotic interstitial lung diseases, no tobacco use within 6 months
- For chronic lung allograft dysfunction patients: age 40 to 80 years, post lung transplant with clinical diagnosis of CLAD, no tobacco use within 6 months
- For immune-checkpoint-inhibitor pneumonitis patients: age over 18 years, CT findings with ground glass opacities or fibrotic changes related to recent ICI therapy, no tobacco use within 6 months
- Ability to provide written informed consent
You will not qualify if you...
- Presence of electrical implants like pacemakers or perfusion pumps
- Ferromagnetic implants including aneurysm clips, surgical clips, prostheses, artificial hearts, steel valves, metal fragments, shrapnel, or metallic tattoos
- Estimated glomerular filtration rate below 30 mL/min/1.73 m2 within past 90 days for CLAD patients
- History of chronic kidney disease for healthy, lung cancer, pulmonary fibrosis, and ICI pneumonitis groups
- Pregnant or breastfeeding females (negative pregnancy test required prior to participation)
- Claustrophobia
- Cumulative research-related radiation exposure exceeding 50 mSv in the past 12 months
- Inability to lie comfortably inside the MR-PET scanner
- Body mass index over 33
- Clinically unsuitable as determined by investigators
- Known pulmonary disease outside of the study groups, recent pneumonia or respiratory infections within 6 weeks (except for pulmonary fibrosis group)
- Prior thoracic radiation therapy except for lung cancer patients
- Pneumonia or acute respiratory illness within 6 weeks before study entry (except pulmonary fibrosis group)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
S
Sydney B Montesi, MD
CONTACT
A
Abimbola Akinniyi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
5
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