Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Evaluation of the value of 18F-Fluoromisonidazole (18F-FMISO) positron emission tomography hypoxia imaging in idiopathic pulmonary fibrosis - A non-randomized proof-of-concept study comparing patients with idiopathic pulmonary fibrosis and healthy subjects

This research is a pilot study investigating a specific type of scan, called 18F-FMISO PET, for people with idiopathic pulmonary fibrosis (IPF) and healthy individuals. IPF is a serious condition where scars form in the lungs, making it hard to breathe. The 18F-FMISO PET scan looks for areas in the lungs that aren't getting enough oxygen, which is also known as 'hypoxia.' By comparing the scans of people with IPF to healthy volunteers, researchers hope to see if this special imaging technique can provide new insights into how IPF affects the lungs. This could potentially lead to a better understanding of the disease in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Centre Hospitalier Universitaire De Dijon

Enrolment target

Start

26 Aug 2024

idiopathic pulmonary fibrosis

What is this study about?

This study is investigating a new way to look at the lungs using a special type of scan called 18F-FMISO PET. The main idea is to see if this scan can show parts of the lungs that aren't getting enough oxygen, a state medical professionals call 'hypoxia.' In conditions like idiopathic pulmonary fibrosis (IPF), where scarring makes the lungs stiff, it's thought that some areas of the lung might struggle to get enough oxygen. By using this special scan, researchers hope to learn more about how oxygen levels in the lungs are affected by IPF.

Idiopathic pulmonary fibrosis (IPF) is a serious lung disease where the lung tissue becomes scarred and thick, making it increasingly difficult to breathe. We don't fully understand why it happens, which is why researchers are always looking for new ways to study and understand the condition. This particular study is called a 'proof-of-concept' study. This means it's one of the first times this specific scan is being used to investigate oxygen levels in the lungs of people with IPF. They will compare the results from people with IPF to those from healthy volunteers to see if there are clear differences.

The findings from this study, even though it's a small, early-stage trial, could be very important. If the 18F-FMISO PET scan proves to be a useful tool for highlighting low-oxygen areas in the lungs of people with IPF, it could help doctors and researchers understand the disease better. This new understanding might one day lead to more effective ways to diagnose or treat IPF, or to monitor how well existing treatments are working. It's a step towards potentially improving care for people living with this challenging lung condition.

Key takeaways

The study investigates a special scan (18F-FMISO PET) for people with IPF.
It aims to see if the scan can detect low oxygen areas in the lungs.
This is an early-stage 'proof-of-concept' study.
Compares people with IPF to healthy individuals.
The goal is to better understand IPF and potentially improve future care.

Who may be eligible?

To take part in this study, you would need to be an adult, at least 18 years old. The study welcomes both men and women.

The researchers are looking for two groups of people: those diagnosed with idiopathic pulmonary fibrosis (IPF) and healthy individuals who do not have lung conditions or other serious health problems. This allows them to compare findings between the two groups.

Specific health conditions or medications you are taking might affect whether you can join. The study team will review your medical history carefully to make sure it's safe for you to participate and that your involvement will help the study get clear results.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of idiopathic pulmonary fibrosis (IPF), or are you a healthy adult?
Are you comfortable with undergoing a PET scan?
Are you able to attend study visits as required?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would likely have a few visits to the study clinic or hospital. The main part of your participation would involve undergoing the special 18F-FMISO PET scan. This scan involves a small amount of a 'tracer' substance being injected into your bloodstream, which then travels to your lungs and can be detected by the PET scanner. The exact timing and number of scans would be explained in full detail by the study team.

Before and after the scan, you might have other assessments, such as blood tests or breathing tests, to get a full picture of your health. Although no specific medication is being tested in this study, some procedures might involve temporary restrictions (like fasting before a scan). The total time you would be involved in the study, from your first visit to your last, would be clearly explained by the research team. You would be given plenty of information and time to ask questions before agreeing to participate.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. For this study, a potential benefit is contributing to a better understanding of IPF, which could help future patients. You might also receive a thorough medical evaluation as part of the screening process. Potential risks associated with PET scans include exposure to a small amount of radiation, similar to that from other common medical scans like X-rays or CTs. There might also be a small risk of discomfort from injections or claustrophobia during the scan. However, study teams always take great care to minimise risks and ensure your safety. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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France

Common questions

What is idiopathic pulmonary fibrosis (IPF)?

IPF is a chronic lung disease where scar tissue builds up in the lungs, making them stiff and gradually harder to breathe. The cause isn't fully understood.

What is a 18F-FMISO PET scan?

It's a special imaging test that involves injecting a small amount of a safe, mildly radioactive substance. The scanner then creates detailed pictures to show how well certain parts of your body, in this case, your lungs, are working, especially regarding oxygen levels.

Will I get personalised results from the scan?

This study is for research, often meaning individual scan results may not be shared immediately or directly used for your medical treatment, but they contribute to group data to understand the disease better.

Do I have to do anything special before the scan?

You might be asked to fast (not eat or drink) for a few hours before the scan, or to avoid certain activities or medications. The study team will give you clear instructions.

Will I be paid for taking part?

Sometimes studies offer to cover travel expenses or provide a small payment for your time. This would be clearly outlined in the information provided by the study team.