AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

Prospective feasibility pilot study evaluating the value of [68Ga]Ga-PENTIXAFOR PET-CT in patients with locally advanced or metastatic Small Cell Lung Cancer (SCLC) at diagnosis and disease progression (PASSIFLORE)

This study, called PASSIFLORE, is for people who have small cell lung cancer that has spread locally or to other parts of the body. Doctors are using a special scan called a [68Ga]Ga-PENTIXAFOR PET-CT scan. They want to see if this scan provides useful information about the cancer, both when it is first diagnosed and if it changes or comes back after treatment. This is a very early-stage study, meaning doctors are checking if this new scan is practical and safe to use. The main goal is to find out if this type of scan can help doctors better understand the disease and guide treatment decisions in the future.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Institut De Cancerologie De L Ouest

Enrolment target

Start

06 May 2025

cell lung carcinoma

What is this study about?

This study is called PASSIFLORE and it's trying to find new ways to understand small cell lung cancer.

Small cell lung cancer is a type of lung cancer that can spread quickly. Doctors want to see if a special type of scan, called a PET-CT scan, can give them more information about the cancer. This particular PET-CT scan uses something called [68Ga]Ga-PENTIXAFOR. They will use this scan both when people are first diagnosed with the cancer and if the cancer progresses or comes back.

By taking these scans, doctors hope to learn if this new method can help them understand the cancer better. This could lead to more personalised and effective ways to manage the disease in the future. It's important to remember that this is a very early exploratory study (Phase I), which means they are mainly checking if the scan is safe and practical to use.

Key takeaways

Looks at a new PET-CT scan for people with small cell lung cancer.
Aims to understand if this scan provides useful information about the cancer.
This is an early-stage study (Phase I) checking safety and practicality.
Involves patients aged 18 and over, both men and women.
You can withdraw from the study at any time.

Who may be eligible?

To be part of this study, you need to be at least 18 years old. There is no upper age limit, so people of all ages over 18 can be considered.

This study is for both men and women. The main requirement is that you have been diagnosed with small cell lung cancer that is locally advanced (meaning it has grown into nearby tissues) or has spread to other parts of your body (metastatic).

The research team will carefully check other details about your health to make sure this study is right for you and safe. Only your doctor can confirm if you meet all the necessary criteria.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with small cell lung cancer?
Has your cancer been described as locally advanced or metastatic (spread to other areas)?
Are you able to attend appointments for special scans?

Answer every question to see your result.

What does participation involve?

The detailed description of what taking part involves is not provided in this summary. However, in most studies like this, if you join, you would likely have additional appointments for the special PET-CT scans. These scans involve a small injection of a tracer into your arm, and then you lie still in a scanner for a period of time, usually less than an hour. You would likely have these scans at the start of the study and possibly again if your cancer shows progression.

There might be blood tests or other routine health check-ups. The doctors would explain exactly how many visits you would need, how long each visit might take, and whether you would need to stop or change any of your current medications specifically for the study. The total time you would be involved in the study would depend on how your treatment progresses, but the research team would give you a clear schedule.

Potential risks and benefits

Potential benefits of taking part in this study are that you might receive additional information about your cancer from the new-style PET-CT scan, which isn't routinely available. This could potentially help doctors make more informed decisions about your care, though the primary goal of this early-stage study is to gather information for future research. Potential risks are generally associated with the PET-CT scan itself, such as a small exposure to radiation (similar to other medical scans) and potential discomfort from the injection. You also always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is small cell lung cancer?

It's a type of lung cancer that tends to grow and spread quite quickly.

What is a PET-CT scan?

It's a special type of medical scan that helps doctors see what's happening inside your body, combining two different imaging techniques.

What does 'Phase I' mean for a study?

Phase I means it's one of the earliest steps in studying something new, mainly checking if it's safe and practical to use.

Will this scan directly treat my cancer?

No, this study is using a scan to gather more information about your cancer, not to treat it directly.

Can I stop participating in the study if I change my mind?

Yes, you can choose to stop being part of the study at any time, and it won't affect your regular medical care.