Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

SPECT/CT imaging of FPI-2505 in patients with solid tumours; a phase 0 molecular imaging basket trial (SCOPE-study).

This study, called the SCOPE-study, is an early-stage clinical trial looking into a new imaging technique for people with various solid tumours. These tumours include small cell lung cancer, non-small cell lung cancer, bowel cancer, breast cancer, pancreatic cancer, and stomach cancer. The trial uses a special scan called SPECT/CT with a new substance called FPI-2505. The main goal is to see if this new imaging method can help doctors understand more about these cancers. This is a very early study, meaning it's one of the first times this imaging technique is being used in people. It's open to adults aged 18 and over, regardless of their gender.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Fusion Pharmaceuticals Inc.

Enrolment target

Start

15 Jul 2025

small cell lung cancer non-smallcell lung cancer colorectal cancer breast cancer Pancreatic cancer and gastric cancer

What is this study about?

Imagine doctors want to get a very detailed picture of a specific part of a tumour inside your body. This study is testing a new way to do just that using a special imaging technique called SPECT/CT. They're using a new substance, called FPI-2505, which is designed to highlight particular features of the cancer cells when scanned.

This study is focusing on several types of solid tumours, including different kinds of lung cancer, bowel cancer, breast cancer, pancreatic cancer, and stomach cancer. By using this new imaging method, researchers hope to learn more about how these cancers work and how they might respond to future treatments. It's like finding a new magnifying glass to look at something important.

Because this is a very early-stage study (called Phase 0 or Human Pharmacology), it means it's one of the first times this new imaging technique is being used in people. This helps researchers gather important safety information and understand if the imaging method works as expected before potentially moving on to larger studies.

Key takeaways

This is an early research study (Phase 0) looking at a new imaging technique.
It uses a special scan called SPECT/CT with a new substance (FPI-2505) to get detailed pictures of tumours.
The study includes various solid cancers like lung, bowel, breast, pancreatic, and stomach cancer.
It's for adults aged 18 and over, both men and women.
The goal is to learn more about these cancers, not to provide direct treatment.
You have the right to leave the study at any point if you change your mind.

Who may be eligible?

This study is looking for adults aged 18 years and older. Both men and women are welcome to take part.

To be considered for the study, you would need to have been diagnosed with one of the following types of solid tumours: small cell lung cancer, non-small cell lung cancer, colorectal (bowel) cancer, breast cancer, pancreatic cancer, or gastric (stomach) cancer.

The research team will carefully review your medical history and current health to make sure this study is suitable for you. They will explain all the specific requirements in detail.

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.

I am 18 years old or older.
I have been diagnosed with small cell lung cancer, non-small cell lung cancer, bowel cancer, breast cancer, pancreatic cancer, or stomach cancer.
I am willing to have a special scan (SPECT/CT) with an injected substance.
I am able to attend study appointments as required.
My doctor has confirmed that I am generally well enough to participate in a research study.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main activity will involve having a special scan called SPECT/CT. Before the scan, you would receive a small, safe injection of the testing substance called FPI-2505. This substance helps the scan create detailed pictures. You might need to have some blood tests and other routine checks to make sure you're healthy enough for the scan and to monitor how your body reacts to the substance. The clinical team will explain all appointments and assessments clearly, including how long each visit might take. The total duration of your participation in the study would be discussed and agreed upon with the research team.

Potential risks and benefits

Taking part in any study has possible benefits and potential risks. The potential benefit of this study is that it might help doctors learn more about your specific cancer and how future treatments could be developed. However, as this is an early-stage study, there's no guarantee of direct personal benefit from the imaging itself. Potential risks could include side effects from the injected substance, mild discomfort during the scan, or exposure to a small amount of radiation from the imaging procedure. The research team will discuss all known potential risks in detail, and your safety will be closely monitored throughout. Remember, you 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
Netherlands

Common questions

What is SPECT/CT imaging?

SPECT/CT is a type of scan that combines two different imaging methods to create very detailed pictures inside your body, helping doctors see specific areas more clearly.

What is FPI-2505?

FPI-2505 is a new, special substance used in this study. It's designed to attach to certain cancer cells so they show up better on the SPECT/CT scan.

Will I get treatment in this study?

No, this study is about imaging, not treatment. Its main purpose is to gather information about how specific cancers look using a new scanning method.

How long will my participation last?

The team will tell you the exact time commitment, but typically early-stage imaging studies involve a few visits over a shorter period, often focused around the scan itself.

Can I still get my usual cancer treatment if I join?

The research team will discuss how this study fits with any ongoing or planned treatments you might have, ensuring your safety and care come first.