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New treatment option for Interstitial Lung Disease
Official title Collagen-targeted PET Imaging for Early Interstitial Lung Disease
ClinicalTrials.gov ID: NCT05417776
What this study is testing
What is [68Ga]CBP8?
[68Ga]CBP8 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for interstitial lung disease.
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 ability of [68Ga]CBP8 to detect collagen deposition in early interstitial lung disease.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Group 1: First degree relatives of a family member with pulmonary fibrosis (n=8)
- Age greater than 40 years
- Have the ability to give written informed consent
- First degree relative of a family member with pulmonary fibrosis
- No known history of interstitial lung disease
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...
- Historical eGFR of less than 30 mL/min/1.73 m2
- 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
- Group 1: First degree relatives of a family member with pulmonary fibrosis (n=8)
- Age greater than 40 years
- Have the ability to give written informed consent
- First degree relative of a family member with pulmonary fibrosis
- No known history of interstitial lung disease
- No tobacco use within the prior 6 months. Group 2: people with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) (n=22)
- Age greater than 40 years
- Have the ability to give written informed consent
- ILAs or early ILD (defined by presence of reticular markings and / or traction bronchiectasis but absence of a definite UIP pattern)
- 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...
- Historical eGFR of less than 30 mL/min/1.73 m2
- 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 PET-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)
- Pneumonia or other acute respiratory illness within 6 weeks of study entry
- Parenchymal lung disease except for ILD/ILAs or emphysema
- Acute exacerbation of ILD within the prior 6 months
- VATS within the prior 6 months
- Prior radiation therapy to the thorax
- Known allergy to gadolinium.
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, 40 years and older. 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.