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Recruiting Phase 1 NCT03535545

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

Trial Parameters

Condition Pulmonary Fibrosis
Sponsor Massachusetts General Hospital
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2018-08-01
Completion 2027-06-30
Interventions
[68Ga]CBP8PET Imaging

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.

Eligibility Criteria

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

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