RecruitingNAINTERVENTIONAL

Contribution of MUltiparametric Analysis in Bone Scintigraphy for the Characterisation of Solitary Bone Lesions

This study is investigating a new way to look at unusual spots found on bones, called solitary bone lesions. Doctors often need to do a biopsy (take a small sample) to find out if these spots are serious or not. This can be uncomfortable and sometimes has risks. The study uses a more advanced type of bone scan, called SPECT-CT, which combines a traditional bone scan with a detailed X-ray scan. It wants to see if this advanced scan can give a clearer picture of these bone spots. The main goal is to find out if this improved scan can show which spots are definitely not cancerous. If it works, this could help many patients avoid having a biopsy, making their journey simpler and safer. The study wants to make sure this new scan is good enough to help doctors make better decisions about these bone lesions.

At a glance

Status

Recruiting

Phase

Sponsor

Central Hospital, Nancy, France

Enrolment target

Start

11 Sep 2023

Estimated completion

10 Jan 2027

Bone Lesion

What is this study about?

Imagine your doctor finds an unusual spot on one of your bones during a scan. These are sometimes called 'solitary bone lesions.' Often, the next step is to take a small sample of the spot (a biopsy) to check if it's serious or harmless. While biopsies are often necessary, they can be a bit uncomfortable and, like any medical procedure, carry a small risk of complications.

This study is looking at a more advanced type of bone scan called SPECT-CT. Think of a regular bone scan as a general map of your bones, showing areas that are very active. SPECT-CT takes this a step further. It combines the information from a bone scan with a very detailed X-ray image (like a 3D picture). This combination gives doctors a much clearer and more precise view of exactly where the spot is and how active it is.

The main idea behind this research is to see if this super-detailed SPECT-CT scan can help doctors tell the difference between a harmless bone spot and a more serious one without needing a biopsy. If the scan can reliably show that a spot is harmless, it could save patients from unnecessary procedures and their potential risks. This would make the process of investigating bone spots much kinder and safer for patients.

Key takeaways

This study uses an advanced bone scan (SPECT-CT) to look at unusual spots on bones.
The goal is to help doctors decide if a bone spot is harmless without needing a biopsy.
It could potentially make diagnosing bone spots safer and more comfortable for patients.
Participants will have a detailed bone scan that combines two types of imaging.
The study focuses on single, unexplained bone lesions that doctors are considering for a biopsy.

Who may be eligible?

To join this study, you need to be at least 18 years old and have signed a form saying you understand the study and agree to take part. Also, you must be part of a social security system. A key requirement is that you have a single, unexplained spot on your bone that doctors are considering for a biopsy (taking a sample) or removal, based on your standard scans.

There are certain reasons why you might not be able to join. If you are pregnant, breastfeeding, or a woman who could become pregnant and are not using contraception, you cannot take part. You also can't join if you have a medical condition that makes it hard to stay still for the scans, or if you're allergic to the specific medicine used in the bone scan (Technetium-99m-Technescan HDP).

Additionally, some people involved in legal or administrative decisions, or those receiving certain types of psychiatric care, would not be able to participate. This is to make sure everyone in the study can freely choose to take part and can fully understand what's involved.

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?
Do you have a single unexplained spot on your bone that your doctor is thinking of biopsying?
Are you NOT pregnant or breastfeeding, and if you could get pregnant, are you using contraception?
Are you NOT allergic to the specific medicine (Technescan HDP) used in a bone scan?
Can you comfortably stay still for a medical scan?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have a special SPECT-CT bone scan. This scan involves getting a small injection of a safe, mildly radioactive substance. This substance travels through your body and collects in areas of your bones that are very active. A special camera then takes pictures as this substance moves and settles.

The scan itself has three main stages: checking how blood flows to the area, then how quickly the substance is absorbed by the nearby tissues, and finally how much of it is fixed into the bone itself. You will need to remain still during the scanning process. The study doesn't involve any medication other than the substance for the scan, and the total duration would be until the scan is completed and the results are analysed, without long-term follow-up visits specifically for the study. However, your doctors will still manage your bone lesion as usual based on all available information.

Potential risks and benefits

Potential benefits of taking part include contributing to medical knowledge that could help future patients avoid unnecessary biopsies. While you might not directly benefit, the detailed scan could provide additional information about your bone lesion. The risks are generally low; they include a small exposure to radiation from the bone scan, similar to many diagnostic X-rays. There's also the chance of an allergic reaction to the injectable substance used for the scan, though this is rare. Your right to withdraw from the study at any time without affecting your medical care is always protected.

Locations (1)

CHRU Nancy
Verified postcode
Vandœuvre-lès-Nancy, France· Recruiting

Common questions

What is a 'solitary bone lesion'?

It's an unusual, single spot or area found on one of your bones during an imaging scan, like an X-ray or MRI.

What is a SPECT-CT bone scan?

It's a special type of scan that combines a bone scan (which shows bone activity) with a detailed CT scan (which shows bone structure) to get a very clear picture of a bone spot.

Why is this study important?

It aims to see if an advanced scan can help doctors tell if a bone spot is harmless without needing to do a biopsy, which can be uncomfortable and has small risks.

Will I get my scan results?

The results of your scan will be used by your treating doctor as part of your overall care, but the study itself focuses on collecting and analysing data across many patients.

Is the injection for the scan safe?

Yes, the substance used is mildly radioactive and generally considered safe for diagnostic purposes. Your body quickly removes it.

How to find out more

ACHRAF BAHLOUL, MD, MSc

a.bahloul@chru-nancy.fr 383154003 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.