RecruitingNot ApplicableNCT07313878

Evaluation of Acute and Chronic Nephrotoxicity in Acute Lymphatic Leukemia Patients Using Ultrasound Localization Microscopy


Sponsor

University of Erlangen-Nürnberg Medical School

Enrollment

30 participants

Start Date

Nov 19, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

With increasing survival rates in pediatric oncology, reports of long-term side effects persisting decades after treatment are also rising. Clinically evident nephropathies occur in about 5.5% of survivors more than five years after therapy. Chemotherapeutic agents such as ifosfamide, cisplatin, and carboplatin, as well as kidney-directed treatments like radiation, surgery, or stem cell transplantation, increase this risk. Acute kidney injury has also been described in association with cyclophosphamide and high-dose methotrexate, which are used in the treatment of acute lymphoblastic leukemia (ALL). Studies show a high prevalence of albuminuria (around 14.5% of childhood cancer survivors), an early marker of kidney damage, while standard parameters like creatinine often become abnormal only at later stages. Leukemia survivors suffer from vascular late effects caused by persistent endothelial damage triggered by cancer therapies such as anthracyclines, cyclophosphamide, and asparaginase, which increase inflammation and thrombosis risk. These vascular changes may also contribute to kidney injury. ULM is a high-resolution ultrasound technique that uses microbubbles to visualize the microvasculature and resolve dynamic blood flow changes with a resolution beyond the diffraction limit. ULM is independent of kidney or liver function, has been applied in various organs, and was recently used for the first time to visualize glomeruli-the smallest functional units of the kidney-in humans. This method enables early detection of glomerular injury as a consequence of vascular damage, even before albuminuria appears, potentially allowing earlier adaptation of follow-up and initiation of treatment. This pilot project focuses on survivors of ALL, as they are the largest and best studied pediatric cancer patient group also regarding late effects and, therefore, a sufficient number of individuals can be expected for his monocentric approach. Vascular functional impairment of the kidney could be detected at an early stage and the follow-up structures and measures such as the early use of nephroprotective drugs could be adapted.


Eligibility

Min Age: 3 YearsMax Age: 17 Years

Inclusion Criteria3

  • Diagnosed acute lymphatic leukemia
  • From 3 years to \< 18 years
  • completed oncological treatment or treatment day \< 50 according to therapy protocol and no administration of CPM before first examination.

Exclusion Criteria7

  • Known allergic disposition to SonoVue / other contrast agents
  • Tattoo in the area of the examination field
  • Pregnancy
  • Breastfeeding mothers
  • Contraindication for the use of Sonovue
  • Critical condition
  • Known clinically evident renal impairment

Interventions

DIAGNOSTIC_TESTUltrasound Localization Microscopy (ULM)

Single Examination: ULM of the kidney after application of a contrast medium (SonoVue®, intravenous).

DIAGNOSTIC_TESTUltrasound Localization Microscopy (ULM)

ULM of the kidney after application of a contrast medium (SonoVue®, intravenous) at two different time points: Timepoint 1: Before initiation of therapy, latest day 50 before 1st high-dose methotrexate or cyclophosphamide. Timepoint 2: After termination of intensive treatment (after 6-9 months).

DIAGNOSTIC_TESTBlood sample

Blood draw (including BB, Diff, Glucose, Na, K, Cl, Ca, LDH, Crea, Cystatin C, Uric Acid, CRP, Albumin, Ferritin, Total Protein) through venous access.

DIAGNOSTIC_TESTBlood sample

Blood draw (including BB, Diff, Glucose, Na, K, Cl, Ca, LDH, Crea, Cystatin C, Uric Acid, CRP, Albumin, Ferritin, Total Protein) through venous access at Timepoint 1 and 2.

DIAGNOSTIC_TESTUrinanalysis

Examination of urine for erythrocytes, leukocytes, pH value, nitrite, protein, blood, and electrolytes.

DIAGNOSTIC_TESTUrinanalysis

Examination of urine for erythrocytes, leukocytes, pH value, nitrite, protein, blood, and electrolytes at Timepoint 1 and Timepoint 2.

DIAGNOSTIC_TESTRenal sonography

Renal sonography including resistance index (RI), Doppler signal, flow velocity, and others.

DIAGNOSTIC_TESTRenal sonography

Renal sonography including resistance index (RI), Doppler signal, flow velocity, and others at time point 1 and time point 2.


Locations(1)

Department of Pediatrics and Adolescent Medicine

Erlangen, Baveria, Germany

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NCT07313878