Clinical trial Recruiting at 1 site Interventional Ages 3 to 17

Ultrasound microbubble imaging to detect kidney damage in children and teens with acute lymphoblastic leukemia

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

Run by University of Erlangen-Nürnberg Medical School · NCT07313878 · Data updated 2026-11-12

We will try a special ultrasound microbubble technique plus blood and urine tests to see if they can find early kidney damage in children and teens treated for acute lymphoblastic leukemia.

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Quick facts

Study typeInterventional
Ages3 Years to 17 Years
SexAll
Enrollment30 (estimated)
SponsorUniversity of Erlangen-Nürnberg Medical School
Academic / other
Drugs / interventionsradiation, methotrexate, cyclophosphamide
Locations1 site (Erlangen, Baveria)
StatusRecruiting
StartedNovember 19, 2025
Main results expectedNovember 19, 2026
Study endsNovember 30, 2026
Registry record updatedJanuary 2, 2026
Trial IDNCT07313878 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children aged 3 to under 18 with diagnosed ALL who have completed oncological treatment or are within 50 days of therapy start and have not yet received cyclophosphamide, and who do not have known clinical kidney impairment.

Probably not a fit

Patients with known clinically evident renal impairment, contraindications to SonoVue or other contrast agents, pregnancy or breastfeeding, tattoos over the scan area, or who are critically ill are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will use ultrasound localization microscopy (ULM) with a microbubble contrast agent together with blood samples and urine analysis to image kidney microvasculature in children and adolescents aged 3 to under 18 with acute lymphoblastic leukemia. Participants may be survivors who have completed treatment or patients within 50 days of therapy start who have not yet received cyclophosphamide. The protocol combines noninvasive imaging for microvascular changes with laboratory markers such as albuminuria, an early sign of kidney damage, to detect acute and chronic nephrotoxicity. Patients with known clinically evident renal impairment or contraindications to the contrast agent are excluded.

Why it matters

Potential benefit: If successful, this approach could detect kidney injury earlier than standard tests and enable earlier follow-up or interventions to reduce long-term kidney problems.

How similar studies have gone: Microbubble-enhanced ultrasound and urine albumin screening have shown promise for detecting early kidney microvascular changes in small studies, but ULM in pediatric ALL survivors is largely novel and not yet validated in large cohorts.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

  • Department of Pediatrics and Adolescent Medicine
    Erlangen, Baveria, Germany
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.