Preliminary Evaluation of [68Ga]CBP8 in Healthy Individuals, Lung Cancer, and Idiopathic Pulmonary Fibrosis Patients
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMassachusetts General Hospital
About this trial
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
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
Electrical implants such as cardiac pacemaker or perfusion pump;
Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing;
eGFR of less than 30 mL/min/1.73 m2 within the past 90 days for group 4 subjects; history of chronic kidney disease for subjects in groups 1-3 and 5;
Pregnant or breastfeeding (a negative quantitative serum hCG pregnancy test is required for females having child-bearing potential before the subject can participate);
Trial design
Design model
Sequential
Treatments tested in this trial
[68Ga]CBP8
DrugUp to 15 mCi of \[68Ga\]CBP8 will be administered to each subject.
PET Imaging
Diagnostic testAll subjects will undergo PET imaging after administration of \[68Ga\]CBP8.
Treatment groups
100 Participants
are divided into 5 treatment groupsGroup A: Healthy IndividualsExperimental treatment 2 interventions
Group B: Lung Cancer SubjectsExperimental treatment 2 interventions
Group C: Pulmonary Fibrosis SubjectsExperimental treatment 2 interventions
Group D: Subjects with chronic lung allograft dysfunction (CLAD)Experimental treatment 2 interventions
Group E: Subjects with immune-checkpoint-inhibitor (ICI) pneumonitisExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Ability 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 hoursSecondary outcomes
1
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 monthsOther outcomes
1
Ability of [68Ga]CBP8 to detect collagen deposition in areas of radiation injury.
Probe lung uptake will be measured in lung cancer patients prior to surgical resection and compared to histologic measures of fibrosis.
Time frame
Up to 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov