Acute Lymphoblastic Leukaemias (ALL)HEALEDNCT07313878
Evaluation of Acute and Chronic Nephrotoxicity in Acute Lymphatic Leukemia Patients Using Ultrasound Localization Microscopy
A study testing Ultrasound Localization Microscopy (ULM), Blood sample and Urinanalysis in people with Acute Lymphoblastic Leukaemias (ALL) and Long Term Follow-Up, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Acute Lymphoblastic Leukaemias (ALL), Long Term Follow-Up
- What is being tested?
- Ultrasound Localization Microscopy (ULM), Blood sample and Urinanalysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 19 Nov 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Pediatrics and Adolescent Medicine
Erlangen, Baveria, 91054
Axel Karow, MD, +49 9131 8533118, axel.karow@uk-erlangen.de
Alexander Dierl, MD, +4991318533118, alexander.dierl@uk-erlangen.de
About this study
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.
Read more
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.
- Being tested
- Ultrasound Localization Microscopy (ULM), Blood sample, Urinanalysis, Renal sonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Localization Microscopy (ULM)Diagnostic test
Single Examination: ULM of the kidney after application of a contrast medium (SonoVue®, intravenous).
Ultrasound Localization Microscopy (ULM)Diagnostic test
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).
Blood sampleDiagnostic test
Blood draw (including BB, Diff, Glucose, Na, K, Cl, Ca, LDH, Crea, Cystatin C, Uric Acid, CRP, Albumin, Ferritin, Total Protein) through venous access.
Blood sampleDiagnostic test
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.
UrinanalysisDiagnostic test
Examination of urine for erythrocytes, leukocytes, pH value, nitrite, protein, blood, and electrolytes.
UrinanalysisDiagnostic test
Examination of urine for erythrocytes, leukocytes, pH value, nitrite, protein, blood, and electrolytes at Timepoint 1 and Timepoint 2.
Renal sonographyDiagnostic test
Renal sonography including resistance index (RI), Doppler signal, flow velocity, and others.
Renal sonographyDiagnostic test
Renal sonography including resistance index (RI), Doppler signal, flow velocity, and others at time point 1 and time point 2.
| Study group | Role | What they receive |
|---|---|---|
| Early therapeutic effects | Experimental | * Diagnosed acute lymphatic leukemia
* Treatment day < 50 according to therapy protocol / no administration of CPM before first examination
* From 3 years to < 18 years Receives: Diagnostic Test: Ultrasound Localization Microscopy (ULM); Diagnostic Test: Blood sample; Diagnostic Test: Urinanalysis; Diagnostic Test: Renal sonography |
| Late therapeutic effects | Experimental | * Diagnosed acute lymphatic leukemia
* Completed oncological treatment
* From 3 years to < 18 years Receives: Diagnostic Test: Ultrasound Localization Microscopy (ULM); Diagnostic Test: Blood sample; Diagnostic Test: Urinanalysis; Diagnostic Test: Renal sonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
CEUS Measurement 1
Peak enhancement (PE)
Measured: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
CEUS Measurement 2
Wash-in area under the curve (WIAUC)
Measured: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
CEUS Measurement 3
Wash-in perfusion index (WiPI)
Measured: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
CEUS Measurement 4
Wash-in rate (WIR)
Measured: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
CEUS Measurement 5
Wash-out under the curve (WoAUC)
Measured: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
CEUS Measurement 6
Wash-in and wash-out under the curve (WiWoAUC)
Measured: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
CEUS Measurement 7
Wash-out rate (WoR)
Measured: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
CEUS Measurement 8
Time to peak (TTP)
Measured: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
CEUS Measurement 9
Rise time (RT)
Measured: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
CEUS Measurement 10
Mean transit time (local) (mTTI)
Measured: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
CEUS Measurement 11
Fall time (FT)
Measured: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
CEUS Measurement 12
Peak enhancement (PE)
Measured: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
Secondary outcomes (9)
Blood Count
Complete blood count with number of red and white blood cells and platelets per µl
Measured: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
Urine status
Measurement of proteinuria in mg/l with protein differentiation
Measured: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
RI
Resistance index (Sonography)
Measured: Measurement of proteinuria with protein differentiation
Flow velocity
Flow velocity in Doppler Signal (Sonography)
Measured: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
Weigth
Weigth of the participant in kilograms
Measured: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
Height
Height of the participant in meters
Measured: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
BP
Measurement of systolic, diastolic and mean blood pressure in mmHg
Measured: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
Electrolytes
Concentration of serum electrolytes (Na, K, Cl, Mg, P) in mmol/L.
Measured: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
Creatinin and urea level
Serum Creatinin and urea level in mg/dl
Measured: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start19 Nov 2025
- Primary completion19 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukaemias (ALL)Studies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313878
- Sponsor's protocol ID
- HEALED-ULM
- Acronym
- HEALED
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The raw, individual and identifiable patient data are protected and are not available due to data privacy laws. Further data sets are planned to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Acute and Chronic Nephrotoxicity in Acute Lymphatic Leukemia Patients Using Ultrasound Localization Microscopy
- ClinicalTrials.gov ID
- NCT07313878
- Acronym / sponsor ID
- HEALED / HEALED-ULM
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- 19 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early therapeutic effects | Experimental | Diagnostic Test: Ultrasound Localization Microscopy (ULM), Diagnostic Test: Blood sample, Diagnostic Test: Urinanalysis, Diagnostic Test: Renal sonography* Diagnosed acute lymphatic leukemia * Treatment day < 50 according to therapy protocol / no administration of CPM before first examination * From 3 years to < 18 years |
| Late therapeutic effects | Experimental | Diagnostic Test: Ultrasound Localization Microscopy (ULM), Diagnostic Test: Blood sample, Diagnostic Test: Urinanalysis, Diagnostic Test: Renal sonography* Diagnosed acute lymphatic leukemia * Completed oncological treatment * From 3 years to < 18 years |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound Localization Microscopy (ULM)Single Examination: ULM of the kidney after application of a contrast medium (SonoVue®, intravenous). | Diagnostic test | Early therapeutic effects |
| Ultrasound 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 test | Late therapeutic effects |
| Blood sampleBlood draw (including BB, Diff, Glucose, Na, K, Cl, Ca, LDH, Crea, Cystatin C, Uric Acid, CRP, Albumin, Ferritin, Total Protein) through venous access. | Diagnostic test | Early therapeutic effects |
| Blood sampleBlood 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 test | Late therapeutic effects |
| UrinanalysisExamination of urine for erythrocytes, leukocytes, pH value, nitrite, protein, blood, and electrolytes. | Diagnostic test | Early therapeutic effects |
| UrinanalysisExamination of urine for erythrocytes, leukocytes, pH value, nitrite, protein, blood, and electrolytes at Timepoint 1 and Timepoint 2. | Diagnostic test | Late therapeutic effects |
| Renal sonographyRenal sonography including resistance index (RI), Doppler signal, flow velocity, and others. | Diagnostic test | Early therapeutic effects |
| Renal sonographyRenal sonography including resistance index (RI), Doppler signal, flow velocity, and others at time point 1 and time point 2. | Diagnostic test | Late therapeutic effects |
Primary outcome
CEUS Measurement 1
Time frame: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
Peak enhancement (PE)
CEUS Measurement 2
Time frame: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
Wash-in area under the curve (WIAUC)
CEUS Measurement 3
Time frame: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
Wash-in perfusion index (WiPI)
CEUS Measurement 4
Time frame: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
Wash-in rate (WIR)
CEUS Measurement 5
Time frame: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
Wash-out under the curve (WoAUC)
CEUS Measurement 6
Time frame: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
Wash-in and wash-out under the curve (WiWoAUC)
CEUS Measurement 7
Time frame: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
Wash-out rate (WoR)
CEUS Measurement 8
Time frame: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
Time to peak (TTP)
CEUS Measurement 9
Time frame: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
Rise time (RT)
CEUS Measurement 10
Time frame: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
Mean transit time (local) (mTTI)
CEUS Measurement 11
Time frame: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
Fall time (FT)
CEUS Measurement 12
Time frame: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
Peak enhancement (PE)
9 secondary outcomes
Blood Count
Time frame: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
Urine status
Time frame: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
RI
Time frame: Measurement of proteinuria with protein differentiation
Flow velocity
Time frame: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
Weigth
Time frame: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
Height
Time frame: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
BP
Time frame: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
Electrolytes
Time frame: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
Creatinin and urea level
Time frame: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Yes. The raw, individual and identifiable patient data are protected and are not available due to data privacy laws. Further data sets are planned to be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Localization Microscopy (ULM), Blood sample and Urinanalysis in people with Acute Lymphoblastic Leukaemias (ALL) and Long Term Follow-Up, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Axel Karow, MD (+4991318533118, axel.karow@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CEUS Measurement 1 (time frame: Study arm early therapeutic effects: Baseline before day 50 of the therapy and follow up after completion of intensive chemotherapy Study arm late therapeutic effects: Baseline at a single-time point in oncological follow-up care). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.