Ultrasound microbubble imaging to detect kidney damage in children and teens with acute lymphoblastic leukemia
Evaluation of Acute and Chronic Nephrotoxicity in Acute Lymphatic Leukemia Patients Using Ultrasound Localization Microscopy
NA · University of Erlangen-Nürnberg Medical School · NCT07313878
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 3 Years to 17 Years |
| Sex | All |
| Sponsor | University of Erlangen-Nürnberg Medical School (other) |
| Drugs / interventions | radiation, methotrexate, cyclophosphamide |
| Locations | 1 site (Erlangen, Baveria) |
| Trial ID | NCT07313878 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Erlangen, Baveria
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Lymphoblastic Leukaemias, Long Term Follow-Up