PET/CT Imaging for Idiopathic Pulmonary Fibrosis
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: University of Alabama at Birmingham
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of the study is to see if imaging with fluorine-18 Fluorodeoxyglucose (\[18F\] FDG) and fluorine-18 Displacement Per Atom (\[18F\]DPA-714) using positron emission tomography and computed tomography (PET/CT) will show lung inflammation and fibrosis in patients diagnosed with idiopathic pulmonary fibrosis (IPF). This study may help physicians and researchers better understand how best to treat patients with IPF in the future.
Is the treatment in the trial 'PET/CT Imaging for Idiopathic Pulmonary Fibrosis' promising?Yes, PET/CT imaging is promising for idiopathic pulmonary fibrosis because it helps doctors better understand the severity of the disease and predict how it might progress. This can lead to more informed treatment decisions and potentially improve patient outcomes.457812
What safety data exists for PET/CT imaging in IPF treatment using [F-18]FDG and [F-18]DPA-714?The provided research does not contain specific safety data for PET/CT imaging using [F-18]FDG and [F-18]DPA-714 in the treatment of idiopathic pulmonary fibrosis (IPF). The studies focus on the safety of antifibrotic drugs nintedanib and pirfenidone, which are used to treat IPF, but do not address the safety of PET ligands or imaging techniques.2391011
What data supports the idea that PET/CT Imaging for Idiopathic Pulmonary Fibrosis is an effective treatment?The available research shows that PET/CT imaging, specifically using 18F-FDG, can help predict the severity and progression of idiopathic pulmonary fibrosis (IPF). This imaging technique is useful in assessing how serious the disease is and can provide insights into the patient's prognosis, or likely outcome. While the studies focus on predicting disease outcomes rather than directly treating IPF, this information can be valuable for doctors in making informed treatment decisions. However, there is no direct evidence from the provided research that PET/CT imaging is an effective treatment for IPF itself.156812
Do I need to stop my current medications for this trial?The trial protocol does not specify if you need to stop your current medications. However, if you are taking more than 20 mg of prednisone (or equivalent) for over 14 days in the past month or any cellular immunosuppressant in the last month, you may not be eligible to participate.
Eligibility Criteria
This trial is for adults aged 40-85 with a confirmed diagnosis of idiopathic pulmonary fibrosis (IPF) according to specific criteria, who can consent and follow study procedures. They must have certain lung function levels and genetic markers. Excluded are those with severe heart disease, liver disease, recent cancer (except skin), diabetes, recent IPF exacerbation or infection, high-dose steroid or immunosuppressant use in the last month, and current smokers/vapers.Inclusion Criteria
I am between 40 and 85 years old.
My genetic test shows I have a specific marker (SNP rs6971) for treatment response.
Exclusion Criteria
My genetics show low binding for specific brain markers.
I have an active cancer diagnosis, except for skin cancer.
I have a known liver disease.
I have had radiation therapy to my chest area before.
I have been diagnosed with diabetes (Type 1 or Type 2).
I haven't taken high-dose steroids or immunosuppressants in the last month.
Treatment Details
The trial tests if PET/CT scans using two imaging agents ([18F]FDG and [18F]DPA-714) can effectively show inflammation and fibrosis in the lungs of IPF patients. This could improve understanding of IPF's variability among patients and inform future treatment strategies.
1Treatment groups
Experimental Treatment
Group I: PET/CT using PET ligands [18F]FDG and [18F]DPA-714Experimental Treatment1 Intervention
Find a clinic near you
Research locations nearbySelect from list below to view details:
The University of Alabama at BirminghamBirmingham, AL
Loading ...
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
References
Prognostic Value of Dual-Time-Point 18F-FDG PET for Idiopathic Pulmonary Fibrosis. [2016]The aim of this prospective study was to clarify whether dual-time-point (18)F-FDG PET imaging results are useful to predict long-term survival of idiopathic pulmonary fibrosis (IPF) patients.
The safety of new drug treatments for idiopathic pulmonary fibrosis. [2022]The management of idiopathic pulmonary fibrosis (IPF) has been transformed by the recent approval of two anti-fibrotic drugs, nintedanib and pirfenidone. An increasing number of patients with IPF are receiving treatment with these novel therapies, and the risk of adverse events that may be associated with their use must be carefully evaluated. Areas covered: Safety data about nintedanib and pirfenidone is critically evaluated, including data from randomized clinical trials and post-marketing reports. Management strategies to minimize the occurrence of side effects are summarized. Expert opinion: The safety profile of the two anti-fibrotic drugs approved for clinical use in IPF patients appears to be comparable. Data from clinical trials and initial post-marketing surveillance indicate that most of the observed side effects are mild and easily manageable. However, approximately 1/5 of patients may discontinue treatment as a consequence of side effects. Careful patient counselling, and regular follow-up during therapy could reduce the rate of discontinuations. Ongoing post-marketing surveillance may further inform our understanding of the safety profile of these therapies.
Real World Experiences: Pirfenidone and Nintedanib are Effective and Well Tolerated Treatments for Idiopathic Pulmonary Fibrosis. [2020]Idiopathic Pulmonary Fibrosis (IPF) now has two licensed treatments available. Pirfenidone was the first drug to be licensed and approved for use, followed by nintedanib. We set out our real world experience with these agents in terms of their adverse events profile outside the restrictions of a clinical trial. We have demonstrated in the real world setting, that side effects are common and predominantly gastrointestinal with both therapies. Our study shows that the side effects can be effectively managed in the majority of patients with an acceptable discontinuation rate similar to that seen in the clinical trials. These findings are compelling despite the fact that the patients in our study are older, have severer disease as depicted by baseline lung function and more co-morbidities. Our data provides ongoing evidence of the safety and tolerability of both pirfenidone and nintedanib in patients who would not have met the rigorous criteria to be included in a clinical trial. Both these agents are effective in the management of IPF and slow the progression of this debilitating life limiting condition.
Fluorine-18 fluorodeoxyglucose positron emission tomography/computed tomography in idiopathic pulmonary fibrosis: A new ray of hope! [2020]Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease with median survival of 2-3 years. It is described as fibroproliferative rather than pro-inflammatory disorder with limited treatment options. IPF diagnostics and therapeutics are a hot topic of current research. We describe a case elaborating the utility of the whole body positron emission tomography with 2-deoxy-2-(fluorine-18) fluoro-D-glucose (F-18 FDG) integrated with computed tomography technique in IPF. The area of most intense pulmonary F--18 FDG uptake corresponded to regions of honeycombing suggesting metabolically active disease amenable to pharmacologic intervention. Additional F--18 FDG uptake was seen in mediastinal nodes implying an extrapulmonary component of disease.
Pulmonary 18F-FDG uptake helps refine current risk stratification in idiopathic pulmonary fibrosis (IPF). [2018]Label="PURPOSE">There is a lack of prognostic biomarkers in idiopathic pulmonary fibrosis (IPF) patients. The objective of this study is to investigate the potential of 18F-FDG-PET/ CT to predict mortality in IPF.
Correlation between preoperative 18F-FDG PET/CT findings and postoperative short-term prognosis in lung cancer patients with idiopathic interstitial pneumonia after lung resection. [2021]Label="BACKGROUND" NlmCategory="BACKGROUND">The present study aimed to investigate the correlation between preoperative 2-deoxy-2-[18F]fluoro-d-glucose (18F-FDG) PET/CT findings and short-term survival in lung cancer patients with idiopathic interstitial pneumonia (IIP).
[18F]FMISO PET/CT imaging of hypoxia as a non-invasive biomarker of disease progression and therapy efficacy in a preclinical model of pulmonary fibrosis: comparison with the [18F]FDG PET/CT approach. [2022]Label="PURPOSE">Idiopathic pulmonary fibrosis (IPF) is a progressive disease with poor outcome and limited therapeutic options. Imaging of IPF is limited to high-resolution computed tomography (HRCT) which is often not sufficient for a definite diagnosis and has a limited impact on therapeutic decision and patient management. Hypoxia of the lung is a significant feature of IPF but its role on disease progression remains elusive. Thus, the aim of our study was to evaluate hypoxia imaging with [18F]FMISO as a predictive biomarker of disease progression and therapy efficacy in preclinical models of lung fibrosis in comparison with [18F]FDG.
The Value of 18F-FDG PET/CT in Evaluating Disease Severity and Prognosis in Idiopathic Pulmonary Fibrosis Patients. [2022]Label="BACKGROUND" NlmCategory="BACKGROUND">Several parameters are useful for assessing disease severity in idiopathic pulmonary fibrosis (IPF); however, the role of 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) is not well-defined. We aimed to evaluate the value of 18F-FDG PET/CT for assessing disease severity and prognosis in IPF patients.
Evaluation of the potential complication of interstitial lung disease associated with antifibrotic drugs using data from databases reporting spontaneous adverse effects. [2023]Interstitial lung disease (ILD), as an adverse effect of certain drugs, leads to inflammation and damage in the walls of the alveoli, making it difficult for the alveoli to take up oxygen. Interstitial pneumonia with no identifiable cause is called idiopathic interstitial pneumonia (IIP), and, among the major IIPs, idiopathic pulmonary fibrosis (IPF) is diagnosed in about half of patients. Current treatment options are limited, among which the antifibrotic drugs nintedanib (Ofev) and pirfenidone (Pirespa) are the first-line drugs. In this study, we investigated the incidence of ILD possibly caused by antifibrotic agents using data from the Japanese Adverse Drug Event Report (JADER) database, a database of spontaneous adverse event reports published by the Pharmaceuticals and Medical Devices Agency (PMDA), and the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS), published by the FDA. We used the FAERS and JADER to detect the signals of adverse events on the basis of reporting odds ratios. The relationship between indications and adverse events was clarified by separating indications and adverse events using the spontaneous adverse event reporting database with novel drug involvement. Regarding the involvement of nintedanib and pirfenidone in the development of ILD, JADER and FAERS showed signals for both nintedanib and pirfenidone as suspect drugs, and no signals for nintedanib or pirfenidone as concomitant drug interactions were detected. We highlight this because there are only a few effective drugs for IPF, and effective and safe drug therapies should be implemented by taking into consideration drug-induced ILD.
Long-Term Safety of Antifibrotic Drugs in IPF: A Real-World Experience. [2022]Pirfenidone and nintedanib are the only two drugs approved for the treatment of idiopathic pulmonary fibrosis (IPF). Both proved to be safe and well-tolerated in clinical trials, but real-world data and direct comparisons are scarce. This real-life study explored the safety profile of pirfenidone and nintedanib with a prolonged follow-up. We retrospectively collected clinical status, adverse events (AEs), and treatment changes from IPF patients who had started an antifibrotic treatment at our centre from December 2011 to December 2020, including 192 patients treated with pirfenidone and 89 with nintedanib. The majority of patients in both groups experienced one or more AEs during the follow-up. A higher proportion of AEs in the nintedanib group were effectively treated with behavioural modifications or additional medications compared with the pirfenidone group (52.5% vs. 40.6%, p = 0.04). Overall, a difference in the impact of AEs due to nintedanib versus pirfenidone resulted in a lower permanent discontinuation of therapy (8.3% vs. 18.3%, p = 0.02), with the latter being associated with a higher risk of drug discontinuation at 48 months after initiation (OR = 2.52, p = 0.03). Our study confirms the safety profile of antifibrotic drugs in IPF but highlights that AEs due to nintedanib are usually easier to manage and lead to fewer cases of permanent discontinuation of therapy.
Factors associated with dose reduction of pirfenidone in patients with idiopathic pulmonary fibrosis: A study based on real-world clinical data. [2023]Although pirfenidone slows disease progression in patients with idiopathic pulmonary fibrosis (IPF), in clinical practice, patients often cannot tolerate the recommended dose because of several adverse events. This study aimed to investigate adverse events associated with pirfenidone and factors associated with dose reduction.
Optimization of an Allysine-Targeted PET Probe for Quantifying Fibrogenesis in a Mouse Model of Pulmonary Fibrosis. [2023]Idiopathic pulmonary fibrosis (IPF) is a destructive lung disease with a poor prognosis, an unpredictable clinical course, and inadequate therapies. There are currently no measures of disease activity to guide clinicians making treatment decisions. The aim of this study was to develop a PET probe to identify lung fibrogenesis using a pre-clinical model of pulmonary fibrosis, with potential for translation into clinical use to predict disease progression and inform treatment decisions.