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New treatment option for Pulmonary Fibrosis
Official title Preliminary Evaluation of [68Ga]CBP8 in Healthy Individuals, Lung Cancer, and Idiopathic Pulmonary Fibrosis Patients
ClinicalTrials.gov ID: NCT03535545
What this study is testing
What is [68Ga]CBP8?
[68Ga]CBP8 is an investigational medicine, being studied as a potential treatment for pulmonary fibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this study is to investigate the safety of [68Ga]CBP8 and its efficacy to detect collagen deposition in pulmonary fibrosis.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Total enrollment for all groups will not exceed 100 people.
- Group 1: Healthy people
- 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...
- Have the ability to give written informed consent;
You likely can't join if
- 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...
- eGFR of less than 30 mL/min/1.73 m2 within the past 90 days for group 4 people; history of chronic kidney disease for people 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...
- Claustrophobic reactions;
- Research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);
See the full eligibility criteria
- Total enrollment for all groups will not exceed 100 people.
- Group 1: Healthy people
- 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 people
- 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: people 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...
- Age: 40-80 years old;
- Have the ability to give written informed consent;
- No tobacco use within the prior 6 months Group 4: people 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 to give written informed consent;
- No tobacco use within the prior 6 months Group 5: people with immune-checkpoint-inhibitor (ICI) pneumonitis
- CT findings with ground glass opacities / consolidation or fibrotic changes with new onset during or within 3 months of receipt of ICI therapy
- Age greater than 18 years
- Have the ability to give written informed consent
- No tobacco use within the prior 6 months
- 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...
- eGFR of less than 30 mL/min/1.73 m2 within the past 90 days for group 4 people; history of chronic kidney disease for people 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);
- Claustrophobic reactions;
- Research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);
- Unable to lie comfortably on a bed inside the MR-PET;
- BMI \> 33 (limit of the MRI table);
- Determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening visit and/or during study procedures);
- Known history of pulmonary disease (except for pulmonary fibrosis in the study group, ICI pneumonitis in the study group, or CLAD in the study group), recent pneumonia or respiratory tract infections within 6 weeks of...
- Pneumonia or other acute respiratory illness within 6 weeks of study entry (except for pulmonary fibrosis), pneumonia defined with elevated WBC, fever, infiltrate on CXR and need for antibiotics
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.