Preliminary Evaluation of [68Ga]CBP8 in Healthy Individuals, Lung Cancer, and Idiopathic Pulmonar… (NCT03535545) | Clinical Trial Compass
RecruitingPhase 1
Preliminary Evaluation of [68Ga]CBP8 in Healthy Individuals, Lung Cancer, and Idiopathic Pulmonary Fibrosis Patients
United States100 participantsStarted 2018-08-01
Plain-language summary
The goal of this study is to investigate the safety of \[68Ga\]CBP8 and its efficacy to detect collagen deposition in pulmonary fibrosis.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…
What they're measuring
1
Ability to detect increased collagen deposition in pulmonary fibrosis.