The goal of this study is to investigate the safety of \[68Ga\]CBP8 and its efficacy to detect collagen deposition in pulmonary fibrosis.
The investigators have developed \[68Ga\]CBP8, a gallium-68 labeled collagen binding PET imaging probe, which selectively binds collagen type I. Collagen deposition is a pivotal event in several human conditions including pulmonary fibrosis. The investigator's studies in mice showed that \[68Ga\]CBP8 binds collagen with high affinity and has excellent pharmacological and pharmacokinetic profiles with high target uptake and low retention in background tissues and organs. \[68Ga\]CBP8 was shown in a mouse model to be effective for detecting lung fibrosis. \[68Ga\]CBP8 showed high specificity for pulmonary fibrosis and high target:background ratios in diseased animals. In addition, \[68Ga\]CBP8 could be used to monitor response to treatment. Ex vivo analysis of lung tissue from patients with IPF supported the animal findings. The investigators thus aim to perform the first in human studies of \[68Ga\]CBP8: 1. To evaluate the safety of \[68Ga\]CBP8 and its whole body distribution, metabolism, pharmacokinetics, and radiation burden in healthy volunteers. 2. To establish the accuracy of \[68Ga\]CBP8-PET to detect radiation-induced fibrosis in lung cancer patients and correlate collagen-targeted \[68Ga\]CBP8-PET imaging with HRCT and histology in lung cancer patients. 3. To determine whether collagen deposition as assessed by \[68Ga\]CBP8-PET molecular imaging can predict disease progression in IPF patients and patients with other types of ILD with a fibrotic component.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
100
Up to 15 mCi of \[68Ga\]CBP8 will be administered to each subject.
All subjects will undergo PET imaging after administration of \[68Ga\]CBP8.
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGAbility to detect increased collagen deposition in pulmonary fibrosis.
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.
Time frame: Two hours
Ability of the degree of collagen deposition to predict disease progression.
Probe lung uptake in pulmonary fibrosis patients will be correlated with change in forced vital capacity over the prior 12 months and prospectively over the following 12-36 months.
Time frame: Up to 36 months
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