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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Years to 17 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Erlangen-Nürnberg Medical School Academic / other |
| Drugs / interventions | radiation, methotrexate, cyclophosphamide |
| Locations | 1 site (Erlangen, Baveria) |
| Status | Recruiting |
| Started | November 19, 2025 |
| Main results expected | November 19, 2026 |
| Study ends | November 30, 2026 |
| Registry record updated | January 2, 2026 |
| Trial ID | NCT07313878 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
- Study coordinator: Axel Karow, MD
- Email: axel.karow@uk-erlangen.de
- Phone: +4991318533118
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Long-Term Recovery and Quality of Life after Sepsis in ICUs
This international study follows adults with sepsis in ICUs to see how their quality of life and other outcomes look six months later.
-
Long-term follow up after transvaginal cystocele repair with four-armed collagen-coated mesh
This study tests whether a four-armed collagen-coated polyester mesh used in transvaginal cystocele repair remains safe and effective more than five years after surgery in women who had the procedure.
-
Long-term health of children born to mothers who had a solid organ transplant
This project will look for long-term heart, kidney, and immune system problems in people aged 16 and older who were born to mothers who had a kidney, liver, pancreas, heart, or lung transplant.
-
Long-term follow-up for chronic hepatitis B patients treated with imdusiran
This study looks at how chronic hepatitis B patients feel and what happens to them after stopping their previous treatment with imdusiran for about two years.
-
Weight monitoring with a connected scale after bariatric surgery
This project tests whether using a connected scale to monitor weight can guide follow-up care for people who had Roux-en-Y gastric bypass or sleeve gastrectomy two years earlier.
-
CAYA cancer patients in LMICs: a forward-looking observation of care and outcomes
This study follows children, teens, and young adults with cancer in low- and middle-income countries to see how routine care affects treatment, access, and outcomes over time.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.