Neuroendocrine TumorsPhase 1/2NCT06056362
Comparison of Al18F-NOTA-LM3 With 68Ga-DOTATATE and 68Ga-NODAGA-LM3 PET/CT in Patients With Well-differentiated Neuroendocrine Tumors
A Phase 1/2 study testing Al18F-NOTA-LM3, 68Ga-DOTATATE and 68Ga-NODAGA-LM3 in people with Neuroendocrine Tumors, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This prospective, single-center, double-blinded study investigates the biodistribution, dosimetry, safety, and diagnostic ability of Al18F-NOTA-LM3 in patients with well-differentiated neuroendocrine tumors. And compares the diagnostic ability of Al18F-NOTA-LM3 with 68Ga-DOTATATE PET/CT and 68Ga-NODAGA-LM3 PET/CT. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Al18F-NOTA-LM3, 68Ga-DOTATATE and 68Ga-NODAGA-LM3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2023to 27 Mar 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 80 years.
- Histologically proven, well-differentiated, NETs (G1 or G2).
- No long-acting somatostatin analog treatment within 4 weeks.
- No PRRT treatment within 8 weeks.
Who cannot join
- Combined with other types of tumors.
- Severe liver or renal dysfunction (ALT/AST≥5 ULN, GFR<30ml/min).
- Active infection.
- Pregnant or breast-feeding women.
- Inability to perform PET/CT scans.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Shuyang Zhang, MD
About this study
Official title: Evaluation of Biodistribution, Dosimetry, Diagnostic Ability, and Safety of Al18F-NOTA-LM3 in Patients With Well-differentiated Neuroendocrine Tumors, and Comparison With 68Ga-DOTATATE and 68Ga-NODAGA-LM3: A Prospective, Single-center, Double-blinded Study
This prospective, single-center, double-blinded study investigates the biodistribution, dosimetry, safety, and diagnostic ability of Al18F-NOTA-LM3 in patients with well-differentiated neuroendocrine tumors. And compares the diagnostic ability of Al18F-NOTA-LM3 with 68Ga-DOTATATE PET/CT and 68Ga-NODAGA-LM3 PET/CT. Clinical management will also be compared using different imaging modalities.
Read the detailed description
Somatostatin receptors (SSTR), especially SSTR subtype 2 (SSTR2), are highly expressed in well-differentiated neuroendocrine tumors (NETs). Radiolabeled somatostatin analogs, including 68Ga-DOTATATE, are widely used for NET imaging and play essential roles in primary tumor seeking, staging, as well as management. SSTR antagonists have recently emerged as another type of somatostatin analog and showed better performance than analogs. Our previous studies exhibited better diagnostic efficacy of 68Ga-DOTA-LM3, 68Ga-DOTA-JR11, and 68Ga-NODAGA-LM3 compared to 68Ga-DOTATATE, especially liver metastasis.
18F-labeled radiotracers have shown several advantages compared to 68Ga-labelled tracers, including increased cyclotron production, lower positron energy, and longer half-life when compared to 68Ga, theoretically to the benefit of image quality. The purpose of this study is to investigate the biodistribution, safety, and diagnostic ability of Al18F-NOTA-LM3 in patients with well-differentiated neuroendocrine tumors. And compare the diagnostic ability of Al18F-NOTA-LM3 with 68Ga-DOTATATE PET/CT and 68Ga-NODAGA-LM3 PET/CT. Clinical management related to imaging will also be compared.
Patients with histologically confirmed well-differentiated neuroendocrine tumors (G1 and G2) will be recruited in this study. All patients will be randomized into two arms (A and B): Patients in arm A performed Al18F-NOTA-LM3 and 68Ga-DOTATATE. Patients in arm B performed Al18F-NOTA-LM3 and 68Ga-NODAGA-LM3. The first eight patients will undergo serial PET scans at 5, 15, 30, 45, 60, and 120 min after injection of Al18F-NOTA-LM3. The following patients will perform a whole-body PET/CT scan at 60-90 minutes after injection of Al18F-NOTA-LM3. All patients a whole-body PET/CT scan at 40-60 minutes after administering 68Ga-DOTATATE or 68Ga-NODAGA-LM3. For each patient, the two pet scans should be done within a week and the interval between the two scans should be at least 24h in case of mutual interference.
The images were reviewed by 2 experienced nuclear medicine physicians who were masked to all patients' clinical information. The results were based on consensus, with any discrepant result resolved by a consensus image interpretation by a third senior physician.
The biodistribution, dosimetry, safety, and diagnostic ability of Al18F-NOTA-LM3 will be explored. The diagnostic ability of Al18F-NOTA-LM3 with 68Ga-DOTATATE PET/CT and 68Ga-NODAGA-LM3 PET/CT will be compared. We will also compare the clinical management using different imaging modalities.
- Conditions
- Neuroendocrine Tumors
- Being tested
- Al18F-NOTA-LM3, 68Ga-DOTATATE, 68Ga-NODAGA-LM3
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Al18F-NOTA-LM3Diagnostic test
40 patients will be enrolled in this arm. The first enrolled 8 patients will undergo serial whole-body PET/CT scans at multiple time points (5, 15, 30, 45, 60, and 120 min) after injection of Al18F-NOTA-LM3. The following patients will undergo a whole-body PET/CT scan 60-120 minutes after injection.
68Ga-DOTATATEDiagnostic test
All patients in arm A will undergo a whole-body PET/CT scan 40-60 minutes after injection of 68Ga-DOTATATE. 68Ga-DOTATATE PET/CT and Al18F-NOTA-LM3 PET/CT should be performed within a week and the interval between the two scans at least 24h.
Al18F-NOTA-LM3Diagnostic test
40 patients will be enrolled in this arm. All patients will undergo a whole-body PET/CT scan 60-120 minutes after injection.
68Ga-NODAGA-LM3Diagnostic test
All patients in arm B will undergo a whole-body PET/CT scan 40-60 minutes after injection of 68Ga-NODAGA-LM3. 68Ga-NODAGA-LM3 PET/CT and Al18F-NOTA-LM3 PET/CT should be performed within a week and the interval between the two scans at least 24h.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Al18F-NOTA-LM3 and 68Ga-DOTATATE group | Experimental | Patients will perform an Al18F-NOTA-LM3 PET/CT as well as a 68Ga-DOTATATE PET/CT. Receives: Diagnostic Test: Al18F-NOTA-LM3; Diagnostic Test: 68Ga-DOTATATE |
| Arm B: Al18F-NOTA-LM3 and 68Ga-NODAGA-LM3 group | Experimental | Patients will perform an Al18F-NOTA-LM3 PET/CT as well as a 68Ga-NODAGA-LM3 PET/CT. Receives: Diagnostic Test: Al18F-NOTA-LM3; Diagnostic Test: 68Ga-NODAGA-LM3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Al18F-NOTA-LM3
Adverse effects were recorded according to CTCAE (version 5.0) after radiotracer injection and PET scan.
Measured: From radiotracer injection to 24 hours post-injection.
Detection rate of Al18F-NOTA-LM3 on per-patient basis
Percentage of patients with lesions detected on Al18F-NOTA-LM3 PET/CT.
Measured: From study completion to 6 months after completion.
SUVmax of lesions detected on Al18F-NOTA-LM3 PET/CT
The tracer uptake is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimensional region of interest.
Measured: From study completion to 6 months after completion.
Detection rate of 68Ga-DOTATATE on per-patient basis
Percentage of patients with lesions detected on 68Ga-DOTATATE PET/CT.
Measured: From study completion to 6 months after completion.
SUVmax of lesions detected on 68Ga-DOTATATE PET/CT
The tracer uptake is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimensional region of interest.
Measured: From study completion to 6 months after completion.
Detection rate of 68Ga-NODAGA-LM3 on per-patient basis
Percentage of patients with lesions detected on 68Ga-NODAGA-LM3 PET/CT.
Measured: From study completion to 6 months after completion.
SUVmax of lesions detected on 68Ga-NODAGA-LM3 PET/CT
The tracer uptake is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimensional region of interest.
Measured: From study completion to 6 months after completion.
Secondary outcomes (2)
SUVmax of normal organs
The biodistribution of Al18F-NOTA-LM3 will be evaluated in the following organs: pituitary gland, parotids, thyroids, lungs, blood pool, liver, spleen, pancreas (head and uncinate process), gallbladder, stomach, small intestine, kidneys, and adrenal glands. SUVmax of these organs were measured and recorded.
Measured: From study completion to 6 months after completion.
Absorbed dose of target organs
Absorbed dose of target organs were calculated using HERMES software.
Measured: From study completion to 6 months after completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start23 Mar 2023
- Primary completion27 Mar 2025 (estimated)
- Study completion27 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meixi Liu, MD, Principal investigator, Peking Uion Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056362
- Sponsor's protocol ID
- ALFLM3NET
- Status last verified
- Sep 2024
- First submitted
- 19 Mar 2023
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu M, Zhang Y, Yan X, Zhang H, Ren C, Huang Z, Cheng Y, Xu Q, Li Y, Jia R, Zhu W, Huo L. Assessment of the diagnostic efficacy and clinical significance of [18F]AlF-NOTA-LM3 PET/CT in patients with well-differentiated neuroendocrine tumors. Eur J Nucl Med Mol Imaging. 2026 Jan;53(2):954-967. doi: 10.1007/s00259-025-07484-9. Epub 2025 Aug 5.
PubMed 40762797Liu M, Ren C, Zhang H, Zhang Y, Huang Z, Jia R, Cheng Y, Bai C, Xu Q, Zhu W, Huo L. Evaluation of the safety, biodistribution, dosimetry of [18F]AlF-NOTA-LM3 and head-to-head comparison with [68Ga]Ga-DOTATATE in patients with well-differentiated neuroendocrine tumors: an interim analysis of a prospective trial. Eur J Nucl Med Mol Imaging. 2024 Oct;51(12):3719-3730. doi: 10.1007/s00259-024-06790-y. Epub 2024 Jun 15.
PubMed 38878175
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Biodistribution, Dosimetry, Diagnostic Ability, and Safety of Al18F-NOTA-LM3 in Patients With Well-differentiated Neuroendocrine Tumors, and Comparison With 68Ga-DOTATATE and 68Ga-NODAGA-LM3: A Prospective, Single-center, Double-blinded Study
- ClinicalTrials.gov ID
- NCT06056362
- Acronym / sponsor ID
- ALFLM3NET
- Conditions
- Neuroendocrine Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 27 Mar 2025 (estimated)
- Study completion
- 27 Mar 2025 (estimated)
- First posted
- 28 Sep 2023 (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.
This prospective, single-center, double-blinded study investigates the biodistribution, dosimetry, safety, and diagnostic ability of Al18F-NOTA-LM3 in patients with well-differentiated neuroendocrine tumors. And compares the diagnostic ability of Al18F-NOTA-LM3 with 68Ga-DOTATATE PET/CT and 68Ga-NODAGA-LM3 PET/CT. Clinical management will also be compared using different imaging modalities.
Detailed description
Somatostatin receptors (SSTR), especially SSTR subtype 2 (SSTR2), are highly expressed in well-differentiated neuroendocrine tumors (NETs). Radiolabeled somatostatin analogs, including 68Ga-DOTATATE, are widely used for NET imaging and play essential roles in primary tumor seeking, staging, as well as management. SSTR antagonists have recently emerged as another type of somatostatin analog and showed better performance than analogs. Our previous studies exhibited better diagnostic efficacy of 68Ga-DOTA-LM3, 68Ga-DOTA-JR11, and 68Ga-NODAGA-LM3 compared to 68Ga-DOTATATE, especially liver metastasis.
18F-labeled radiotracers have shown several advantages compared to 68Ga-labelled tracers, including increased cyclotron production, lower positron energy, and longer half-life when compared to 68Ga, theoretically to the benefit of image quality. The purpose of this study is to investigate the biodistribution, safety, and diagnostic ability of Al18F-NOTA-LM3 in patients with well-differentiated neuroendocrine tumors. And compare the diagnostic ability of Al18F-NOTA-LM3 with 68Ga-DOTATATE PET/CT and 68Ga-NODAGA-LM3 PET/CT. Clinical management related to imaging will also be compared.
Patients with histologically confirmed well-differentiated neuroendocrine tumors (G1 and G2) will be recruited in this study. All patients will be randomized into two arms (A and B): Patients in arm A performed Al18F-NOTA-LM3 and 68Ga-DOTATATE. Patients in arm B performed Al18F-NOTA-LM3 and 68Ga-NODAGA-LM3. The first eight patients will undergo serial PET scans at 5, 15, 30, 45, 60, and 120 min after injection of Al18F-NOTA-LM3. The following patients will perform a whole-body PET/CT scan at 60-90 minutes after injection of Al18F-NOTA-LM3. All patients a whole-body PET/CT scan at 40-60 minutes after administering 68Ga-DOTATATE or 68Ga-NODAGA-LM3. For each patient, the two pet scans should be done within a week and the interval between the two scans should be at least 24h in case of mutual interference.
The images were reviewed by 2 experienced nuclear medicine physicians who were masked to all patients' clinical information. The results were based on consensus, with any discrepant result resolved by a consensus image interpretation by a third senior physician.
The biodistribution, dosimetry, safety, and diagnostic ability of Al18F-NOTA-LM3 will be explored. The diagnostic ability of Al18F-NOTA-LM3 with 68Ga-DOTATATE PET/CT and 68Ga-NODAGA-LM3 PET/CT will be compared. We will also compare the clinical management using different imaging modalities.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Al18F-NOTA-LM3 and 68Ga-DOTATATE group | Experimental | Diagnostic Test: Al18F-NOTA-LM3, Diagnostic Test: 68Ga-DOTATATEPatients will perform an Al18F-NOTA-LM3 PET/CT as well as a 68Ga-DOTATATE PET/CT. |
| Arm B: Al18F-NOTA-LM3 and 68Ga-NODAGA-LM3 group | Experimental | Diagnostic Test: Al18F-NOTA-LM3, Diagnostic Test: 68Ga-NODAGA-LM3Patients will perform an Al18F-NOTA-LM3 PET/CT as well as a 68Ga-NODAGA-LM3 PET/CT. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 to 80 years.
- Histologically proven, well-differentiated, NETs (G1 or G2).
- No long-acting somatostatin analog treatment within 4 weeks.
- No PRRT treatment within 8 weeks.
Key exclusion criteria (5 listed)
- Combined with other types of tumors.
- Severe liver or renal dysfunction (ALT/AST≥5 ULN, GFR<30ml/min).
- Active infection.
- Pregnant or breast-feeding women.
- Inability to perform PET/CT scans.
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 |
|---|---|---|
| Al18F-NOTA-LM340 patients will be enrolled in this arm. The first enrolled 8 patients will undergo serial whole-body PET/CT scans at multiple time points (5, 15, 30, 45, 60, and 120 min) after injection of Al18F-NOTA-LM3. The following patients will undergo a whole-body PET/CT scan 60-120 minutes after injection. | Diagnostic test | Arm A: Al18F-NOTA-LM3 and 68Ga-DOTATATE group |
| 68Ga-DOTATATEAll patients in arm A will undergo a whole-body PET/CT scan 40-60 minutes after injection of 68Ga-DOTATATE. 68Ga-DOTATATE PET/CT and Al18F-NOTA-LM3 PET/CT should be performed within a week and the interval between the two scans at least 24h. | Diagnostic test | Arm A: Al18F-NOTA-LM3 and 68Ga-DOTATATE group |
| Al18F-NOTA-LM340 patients will be enrolled in this arm. All patients will undergo a whole-body PET/CT scan 60-120 minutes after injection. | Diagnostic test | Arm B: Al18F-NOTA-LM3 and 68Ga-NODAGA-LM3 group |
| 68Ga-NODAGA-LM3All patients in arm B will undergo a whole-body PET/CT scan 40-60 minutes after injection of 68Ga-NODAGA-LM3. 68Ga-NODAGA-LM3 PET/CT and Al18F-NOTA-LM3 PET/CT should be performed within a week and the interval between the two scans at least 24h. | Diagnostic test | Arm B: Al18F-NOTA-LM3 and 68Ga-NODAGA-LM3 group |
Primary outcome
Safety of Al18F-NOTA-LM3
Time frame: From radiotracer injection to 24 hours post-injection.
Adverse effects were recorded according to CTCAE (version 5.0) after radiotracer injection and PET scan.
Detection rate of Al18F-NOTA-LM3 on per-patient basis
Time frame: From study completion to 6 months after completion.
Percentage of patients with lesions detected on Al18F-NOTA-LM3 PET/CT.
SUVmax of lesions detected on Al18F-NOTA-LM3 PET/CT
Time frame: From study completion to 6 months after completion.
The tracer uptake is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimensional region of interest.
Detection rate of 68Ga-DOTATATE on per-patient basis
Time frame: From study completion to 6 months after completion.
Percentage of patients with lesions detected on 68Ga-DOTATATE PET/CT.
SUVmax of lesions detected on 68Ga-DOTATATE PET/CT
Time frame: From study completion to 6 months after completion.
The tracer uptake is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimensional region of interest.
Detection rate of 68Ga-NODAGA-LM3 on per-patient basis
Time frame: From study completion to 6 months after completion.
Percentage of patients with lesions detected on 68Ga-NODAGA-LM3 PET/CT.
SUVmax of lesions detected on 68Ga-NODAGA-LM3 PET/CT
Time frame: From study completion to 6 months after completion.
The tracer uptake is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimensional region of interest.
2 secondary outcomes
SUVmax of normal organs
Time frame: From study completion to 6 months after completion.
Absorbed dose of target organs
Time frame: From study completion to 6 months after completion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Derived from this study: PubMed 40762797Liu M, Zhang Y, Yan X, Zhang H, Ren C, Huang Z, Cheng Y, Xu Q, Li Y, Jia R, Zhu W, Huo L. Assessment of the diagnostic efficacy and clinical significance of [18F]AlF-NOTA-LM3 PET/CT in patients with well-differentiated neuroendocrine tumors. Eur J Nucl Med Mol Imaging. 2026 Jan;53(2):954-967. doi: 10.1007/s00259-025-07484-9. Epub 2025 Aug 5.
- Derived from this study: PubMed 38878175Liu M, Ren C, Zhang H, Zhang Y, Huang Z, Jia R, Cheng Y, Bai C, Xu Q, Zhu W, Huo L. Evaluation of the safety, biodistribution, dosimetry of [18F]AlF-NOTA-LM3 and head-to-head comparison with [68Ga]Ga-DOTATATE in patients with well-differentiated neuroendocrine tumors: an interim analysis of a prospective trial. Eur J Nucl Med Mol Imaging. 2024 Oct;51(12):3719-3730. doi: 10.1007/s00259-024-06790-y. Epub 2024 Jun 15.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Meixi Liu, MD principal investigator
Peking Uion Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Al18F-NOTA-LM3, 68Ga-DOTATATE and 68Ga-NODAGA-LM3 in people with Neuroendocrine Tumors, run by Peking Union Medical College Hospital at 1 site in China.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Apr 2025. 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 China. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meixi Liu, MD (+86-15010405355, meixiliu_pumc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Al18F-NOTA-LM3 (time frame: From radiotracer injection to 24 hours post-injection.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06056362, which also lists 2 linked publications.
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 Apr 2025.