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Идёт набор NCT06472947

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

Наблюдательное Kidney Transplant Kidney Biopsy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: ULM and MSOT.
Кому может быть актуально
Состояния в реестре: Kidney Transplant, Kidney Biopsy. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

In this study, the condition of the kidney transplant in adults is to be assessed non-invasively using Multispectral Optoacoustic Tomography and Ultrasound Localization Microscopy (ULM). ULM imaging can be performed in a 2-dimensional and a 3-dimensional way (2D and 3D ULM). Therefore, "ULM" in the following texts and measures will refer to 2D and 3D ULM. New, non-invasive markers that allow conclusions to be drawn about the condition of the transplant should reduce the need for invasive diagnostic procedures in the future.

Подробное описание

In this study, the condition of the kidney transplant in adults is to be assessed non-invasively using multispectral multispectral optoacoustic tomography and ultrasound localization microscopy. Associated with common diseases such as arterial hypertension, diabetes mellitus and cardiovascular diseases, chronic renal failure is now a leading cause of death worldwide.

Around 10% of adults in Germany, but children are also affected. The terminal stage of renal insufficiency is defined by a glomerular filtration rate (GFR) which is only 15% of the normal rate and the need for renal replacement therapy in the form of dialysis or transplantation.

Not only the higher quality of life, but also the mortality rate make kidney transplantation the procedure of choice whenever possible.

After successful kidney transplantation, regular monitoring and evaluation of the organ transplant is of great importance to detect a rejection reaction as early as possible.

Among other things, this is done during an extensive annual examination. Not infrequently, and especially in the case of abnormalities in the laboratory diagnosis of blood and urine, a kidney biopsy is also necessary in order to assess the condition of the transplant in the best possible way.

As an invasive diagnostic procedure, the biopsy necessitates a stay in hospital, may result in side effects such as postoperative bleeding and represents a risk and an additional bruden for the patient.

MSOT has already been used to measure renal clearance and the biodistribution of fluorescent substances within the kidney, but new biomarkers have also been established in muscle and intestinal diseases and correlated with clinical scores. ULM has made the visualization of glomeruli, the smallest functional unit of the kidney, in living rats and humans and visualization of cerebral microvasculature in the human brain possible. In this study, the renal function in transplant patients will be evaluated as part of the annual examination and results from histology (biopsy), laboratory and ultrasound diagnostics will be correlated with data from MSOT and 2D and 3D ULM imaging.

The investigators believe that MSOT can be used to gain important molecular insights into the condition of the transplant. With ULM the investigators want to analyze the microvascular architecture within glomerular renal corpuscles and identify changes in perfusion dynamics as morphological signs for transplant evaluation.

Вмешательства

  • Устройство ULM and MSOT
    transplanted kidney will be examined non-invasively with ULM and MSOT

Первичные конечные точки

  • Visualization of microvascular architecture in the transplant kidney [Срок оценки: Day1]
  • Quantification of microvascular dynamics in the transplanted kidney [Срок оценки: Day1]
  • MSOT in human kidney transplant [Срок оценки: Day1]
Вторичные конечные точки (12)
  • ULM visuals and histology [Срок оценки: Day1]
  • ULM visuals and laboratory results [Срок оценки: Day1]
  • ULM visuals and standard sonography [Срок оценки: Day1]
  • ULM quantification and histology [Срок оценки: Day1]
  • ULM quantification and laboratory results [Срок оценки: Day1]
  • MSOT: Hb and histology [Срок оценки: Day1]
  • MSOT: hb and laboratory results [Срок оценки: Day1]
  • MSOT hb and sonography [Срок оценки: Day1]
  • MSOT hb and histology [Срок оценки: Day1]
  • MSOT Lipid and laboratory results [Срок оценки: Day1]
  • MSOT Lipid and sonographic results [Срок оценки: Day1]
  • MSOT lipid and histology [Срок оценки: Day1]

Критерии участия

Критерии включения

  • kidney transplant
  • indication for biopsy set in clinical routine
  • minimum 18 years of age
  • written consent

Критерии исключения

  • allergy against contrast agents/ SonoVue
  • tatoos in examined areas
  • contraindication against SonoVue
  • pregnant women
  • breast feeding women

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Германия · 1 центр
  • Department of Pediatrics and Adolescent Medicine — Erlangen

Идентификаторы

NCT: NCT06472947 · NTX_ULM_MSOT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗