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Non-invasive Evaluation of Graft Condition in Adult Patients With Kidney Transplant Using Ultrasound Localization Microscopy and Multispectral Optoacoustic Tomography

This research is looking at new ways to check the health of a transplanted kidney. For people who have had a kidney transplant, it's really important to keep a close eye on their new kidney to make sure it's working well and to spot any problems early, like rejection. At the moment, this often involves a procedure called a kidney biopsy, where a small piece of the kidney is removed for testing. This can be uncomfortable and has some risks. This study is using two gentle scanning methods, called Ultrasound Localization Microscopy (ULM) and Multispectral Optoacoustic Tomography (MSOT), instead of a biopsy. The hope is that these new scans will give doctors all the information they need without patients having to go through an invasive procedure. This could make monitoring much easier and safer for people with kidney transplants.

At a glance

Status
Recruiting
Sponsor
University of Erlangen-Nürnberg Medical School
Enrolment target
10
Start
18 Jun 2024
Estimated completion
18 Jan 2028

What is this study about?

When someone has a kidney transplant, it's a life-changing operation. These new kidneys need careful monitoring to make sure they're working properly and don't show signs of rejection. Currently, if doctors are worried about a transplanted kidney, they often perform a kidney *biopsy*. This means they use a needle to take a tiny sample of kidney tissue to look at under a microscope. While biopsies are very helpful, they are an 'invasive' procedure, which means they involve breaking the skin. They can be uncomfortable, require a hospital stay, and carry a small risk of side effects like bleeding.

This research project is exploring new, gentle scanning technologies to evaluate the health of transplanted kidneys without needing a biopsy. Researchers are using two types of scans: *Ultrasound Localization Microscopy (ULM)* and *Multispectral Optoacoustic Tomography (MSOT)*. Imagine these as advanced ways of looking inside your kidney in great detail, much like an ultrasound but providing even more information about how the kidney is functioning, including its tiniest parts.

The main goal of this study is to see if these new scanning methods can provide enough information about a kidney's condition. If they can, it might mean that in the future, people with kidney transplants won't need as many biopsies, making their follow-up care much easier and less stressful. This research is a step towards more patient-friendly ways of looking after transplanted organs.

Key takeaways

  • This study evaluates new, gentle scanning methods for transplanted kidneys.
  • The goal is to reduce the need for invasive kidney biopsies in the future.
  • It uses advanced scans called ULM and MSOT.
  • Participants must have had a kidney transplant and be scheduled for a biopsy.
  • This research aims to improve monitoring for transplant patients.

Who may be eligible?

This study is looking for adult patients (aged 18 or over) who have already had a kidney transplant. To be considered, your doctors must have decided that you currently need a kidney biopsy as part of your usual care. You'll also need to be able to understand the study information and give your written permission to take part.

There are some reasons why you wouldn't be able to join the study. These include if you are allergic to certain scanning dye (called 'contrast agents' or 'SonoVue'), or if you have tattoos in the area that needs to be scanned (as this might affect the scan quality). The study also cannot include pregnant or breastfeeding women, or anyone for whom the scanning dye is considered unsafe.

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.

  1. Are you 18 years old or older?
  2. Do you have a kidney transplant?
  3. Has your doctor told you that you need a kidney biopsy soon?
  4. Are you able to give written permission to take part?
  5. Are you *not* pregnant or breastfeeding?
  6. Have you *not* been told you are allergic to 'contrast agents' or 'SonoVue'?
Answer every question to see your result.

What does participation involve?

If you decide to take part, the main difference from your usual care is that you will have the two new scans, ULM and MSOT. These scans are non-invasive, like a regular ultrasound. You will still have your planned kidney biopsy after the scans. The study will mainly involve attending for these extra scans around the time of your annual check-up and planned biopsy. There are no new medications involved, and the overall duration of your participation will be focused around this assessment period. More detailed information on the exact number of visits and the time involved will be given in the patient information leaflet.

Potential risks and benefits

Taking part in this study could mean that in the future, people with kidney transplants might need fewer biopsies. You would also be helping doctors learn more about these new scanning methods. The main risks are linked to the scanning dye used in one of the scans. While generally safe, some people can have allergic reactions. Your medical team will discuss any individual risks with you. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • Department of Pediatrics and Adolescent Medicine
    Verified postcode
    Erlangen, Germany· Recruiting

Common questions

What is a 'non-invasive' test?

A non-invasive test means it doesn't involve breaking the skin or going inside your body, like a regular scan or X-ray.

Why are doctors looking for alternatives to kidney biopsies?

Kidney biopsies are very useful but can be uncomfortable and carry small risks for patients. Doctors want to find gentler ways to get the same information.

Will I still need my biopsy if I join this study?

Yes, if you join this study, you will still have your planned kidney biopsy. The new scans are being tested to see if they can help reduce the need for biopsies in the future.

What are ULM and MSOT?

They are new types of advanced scanning technologies that can look at your kidney in great detail, similar to an ultrasound but providing more in-depth information.

Will this study affect my usual kidney transplant care?

No, your regular care for your kidney transplant will continue as normal. This study is an addition to your standard monitoring.

How to find out more

Ferdinand Hannah Knieling, PD Dr. Dr.

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

Interested in taking part?

Register your interest

Share your details and the research team for "Non-invasive Evaluation of Graft Condition in Adult Patients…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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