Preliminary Evaluation of [68Ga]CBP8 in Healthy Individuals, Lung Cancer Patients Undergoing Radiation Therapy Prior to the Resection of Locally Advanced Tumors, and Idiopathic Pulmonary Fibrosis Patients
Massachusetts General Hospital
Summary
The goal of this study is to investigate the safety of \[68Ga\]CBP8 and its efficacy to detect collagen deposition in pulmonary fibrosis.
Description
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…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- Drug[68Ga]CBP8
Up to 15 mCi of \[68Ga\]CBP8 will be administered to each subject.
- Diagnostic TestPET Imaging
All subjects will undergo PET imaging after administration of \[68Ga\]CBP8.
Location
- Massachusetts General HospitalBoston, Massachusetts