AuthorisedTherapeutic exploratory (Phase II)Interventional

A Phase 2 Study of [68Ga]BED003 for PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications

This research study is testing a new type of scan called a [68Ga]BED003 PET/CT scan. This scan uses a special dye ([68Ga]BED003) to help doctors see certain types of cancer more clearly, such as bowel cancer (colorectal cancer), stomach cancer (gastric cancer), pancreatic cancer, a type of breast cancer (invasive lobular breast cancer), and ovarian cancer. The main goal is to find out how accurate this new scan is at spotting these cancers, especially in the lining of the abdomen (peritoneum), compared to current ways of diagnosing cancer. Researchers will also look at how safe the scan is and how well the images can be read.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Blue Earth Diagnostics Ireland Limited

Enrolment target

Start

28 Apr 2026

Colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).

What is this study about?

This study is investigating a new way to image certain cancers using a special body scan called a [68Ga]BED003 PET/CT scan. Imagine your doctor wants to find out exactly where cancer might be in your body, especially if it's spread to areas like the lining of your tummy (peritoneum). This new scan uses a special substance, [68Ga]BED003, which is designed to stick to a particular protein found in some cancer cells. By sticking to this protein, it lights up on the scan, making it easier for doctors to see where cancer cells might be hiding.

Doctors hope this new scan will be very good at finding these cancer cells and showing their exact location. This could help them to plan the best treatment. The study is particularly focusing on bowel cancer, stomach cancer, pancreatic cancer, a specific type of breast cancer, and ovarian cancer. We want to see how accurate this new scan is compared to the methods we currently use.

By taking part, you would help us understand if this new scanning method is better at detecting cancer. This knowledge could lead to earlier and more accurate diagnoses for many patients in the future, potentially improving their care and treatment options.

Key takeaways

This study tests a new scan to find specific cancers better.
It uses a special substance, [68Ga]BED003, to highlight cancer cells.
Aims to improve diagnosis for bowel, stomach, pancreatic, breast, and ovarian cancers.
The main goal is to check how accurate and safe the new scan is.
Participation helps future patients get better diagnoses.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old. People of any gender can take part.

You would be considered for the study if you have been diagnosed with certain types of cancer, specifically bowel cancer, stomach cancer, pancreatic cancer, a particular kind of breast cancer called invasive lobular breast cancer, or ovarian cancer.

Other specific health conditions or medications might affect whether you can join, but the doctors running the study will check all these details carefully with you.

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 bowel, stomach, pancreatic, a type of breast, or ovarian cancer?
Are you able to travel to the study site for appointments?
Are you comfortable having an injection and a hospital scan?

Answer every question to see your result.

What does participation involve?

If you join this study, you would have an injection of the special [68Ga]BED003 substance. This injection is given just before your PET/CT scan. You would then have the scan itself, which is similar to other scans you might have had. During the scan, doctors will take images at different times – typically 30 and 60 minutes after the injection – to see how the substance shows up. They will also collect information on any effects you might feel during or after the scan. The study does not involve taking any medication besides the injected substance for the scan, but it will involve several follow-up checks to make sure you are well and to assess the scan's results. The total duration of your active involvement in the study will be relatively short, mostly revolving around the scan day and immediate follow-up.

Potential risks and benefits

Potential benefits of taking part include helping doctors understand more about this new scanning method, which could improve how certain cancers are diagnosed in the future. While this study is not designed to directly treat your cancer, the information gathered from your scan could potentially aid in your treatment planning. Potential risks include discomfort from the injection, a very small exposure to radiation from the substances used in the scan (which is carefully controlled), and potential side effects from the injected substance, though these are closely monitored. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Netherlands
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Unverified
Italy

Common questions

What is a PET/CT scan?

A PET/CT scan is a special type of imaging test that combines two scans. It helps doctors see inside your body and find out where any disease might be.

What is [68Ga]BED003?

[68Ga]BED003 is a special liquid substance that is given as an injection. It helps certain cancer cells 'light up' on the PET scan so doctors can see them more clearly.

Will this scan treat my cancer?

No, this study is about testing a new scan to help diagnose cancer better, not to treat it. The information from the scan might help your doctors plan your treatment though.

How long does a PET/CT scan take?

The scan itself can take 30-60 minutes, but with preparation and waiting times, you might be at the hospital for a few hours on the day of your scan.

Will I feel anything from the injection?

You might feel a small sting when the injection is given, similar to other injections you might have had. You might not feel anything else from the liquid itself.