Multiple Myeloma and Malignant Plasma Cell NeoplasmsEarly Phase 1NCT06717113
A Molecular Probe Targeting BCMA for the Clinical Diagnosis of Multiple Myeloma
A Early Phase 1 study testing 18F-FDG and 68Ga-BC1 in people with Multiple Myeloma and Malignant Plasma Cell Neoplasms, run by Peking University First Hospital at 2 sites in China.
Trial summary
Multiple Myeloma (MM), the second most common hematological malignancy, continues to pose challenges in precise clinical identification. As a potential solution, nuclear medicine immuno-PET imaging has emerged as a promising approach. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma and Malignant Plasma Cell Neoplasms
- What is being tested?
- 18F-FDG and 68Ga-BC1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesChina
- Study dates
- 15 Apr 2025to Dec 2028
- Phase
- Early Phase 1
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Suspected multiple myeloma patients scheduled for bone marrow aspiration or tissue biopsy within the past 3 months; able to fully understand and voluntarily participate in the study, with signed informed consent; able to cooperate with the examination.
- Diagnosed symptomatic multiple myeloma patients; able to fully understand and voluntarily participate in the study, with signed informed consent; able to cooperate with the examination.
Who cannot join
- Pregnant women; individuals unable to understand the examination process or who are unable to cooperate.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Department of Nuclear Medicine, Peking University First Hospital
Beijing, Beijing Municipality, 010000
Tianyao Wang, Ph.D., +86-010-83575252, tianyao.wang@pku.edu.cn
Zhao Chen, M.D., +86-010-83572916, 19801258667@163.com
- Enrolling by invitation
Peking University First Hospital
Beijing, Beijing Municipality, 100000
About this study
Official title: Clinical PET Imaging Evaluation of 68Ga-BC1 Probe in Multiple Myeloma
Multiple Myeloma (MM), the second most common hematological malignancy, continues to pose challenges in precise clinical identification. As a potential solution, nuclear medicine immuno-PET imaging has emerged as a promising approach. However, traditional full-length antibody probes suffer from delayed tumor uptake peaks and low target-to-background ratios, limiting their clinical utility. In our study, a peptide or nanobody targeting BCMA was developed by computer-aided designing, which was subsequently radiolabeled with 68Ga to create a novel molecular probe, 68Ga-MM-BC1. This research aims to overcome the diagnostic limitations of MM and may also offer valuable insights for molecular-targeted imaging in other malignant tumors.
Read the detailed description
Multiple Myeloma (MM) predominantly affects the elderly and often presents insidiously, with most patients being diagnosed at an advanced stage. As China\'s population ages, the incidence of MM is increasing, now surpassing that of acute leukemia. The primary clinical manifestation is bone destruction, which lacks specificity. Diagnosis primarily relies on invasive bone marrow biopsies to detect clonal plasma cell proliferation. However, improper selection of the biopsy site can lead to false-negative results. BCMA is highly expressed on the surface of malignant plasma cells in MM, making it a characteristic tumor biomarker for this disease.
With the rising incidence of malignant tumors in China, there is an increasing demand for radiopharmaceuticals in clinical practice. Given the limitations of 18F-FDG in PET imaging, particularly regarding specificity, the development of novel targeted nuclear medicine molecular probes holds significant academic and clinical value. This is especially true for monitoring the therapeutic effects of peptide or nanobody-based treatments targeting BCMA, which offers distinct advantages. This project focuses on utilizing a peptide or nanobody with high affinity for BCMA as the targeting group for radiopharmaceuticals, exploring the diagnostic efficacy of 68Ga-BC1 in MM patients with high BCMA expression. This approach not only aids in the early diagnosis of MM but also helps tailor effective precision treatments for patients based on their BCMA expression levels.
68Ga-BC1, a novel BCMA-targeting molecular probe labeled with 68Ga, has potential applications in the diagnosis and research of various BCMA-expressing malignancies, including MM. 68Ga-BC1 is synthesized using THP as a bifunctional chelator to coordinate with 68Ga^3+, and the labelling process is simple, allowing for direct use without purification. It demonstrates high in vivo stability and significant tumor uptake in tumor-bearing mice, with superior imaging performance. In this project, the automated labelling process of 68Ga-BC1 will be studied, and quality control measures for the resulting radiopharmaceutical injection will be established. A quality standard for this new PET probe will be set, laying the groundwork for the clinical translation of this drug within China. This study aims to provide valuable data on 68Ga-BC1 PET/CT imaging, offering insights for the early diagnosis, treatment planning, and efficacy evaluation of patients with BCMA-expressing malignancies.
- Being tested
- 18F-FDG, 68Ga-BC1
- Keywords
- multiple myeloma, molecular probe, Immuno-PET
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDGDrug
Prior to the examination, patients will be required to fast for at least 6 hours. 18F-FDG (0.05-0.1 mCi/kg) will be intravenously injected, and one hour after the injection, head and torso imaging will be performed using a Shanghai United Imaging uMI 780 PET/CT scanner, covering the region from the top of the head to the upper third of the thigh. The patient will lie supine and breathe calmly during the procedure. After image acquisition, the data will be reconstructed using the OSEM method to generate coronal, sagittal, transverse, and PET/CT fusion images.
68Ga-BC1Drug
The prepared and quality-controlled 68Ga-BC1 (0.05-0.1 mCi/kg) will be intravenously injected into the patient. Two hours after the injection, whole-body imaging will be performed using a Shanghai United Imaging uMI 780 PET/CT scanner, covering the region from the top of the head to the mid-thigh. If any indeterminate lesions are found during the routine imaging, delayed imaging will be performed for further differentiation. The patient will lie supine and breathe calmly during the procedure. After image acquisition, the data will be reconstructed using the OSEM method to generate coronal, sagittal, transverse, and PET/CT fusion images.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-BC1 PET/CT diagnosis | Experimental | Not described Receives: Drug: 68Ga-BC1 |
| 18F-FDG PET/CT diagnosis | Active comparator | Not described Receives: Drug: 18F-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
MM patients will be recruited to undergo PET/CT imaging using 68Ga-NB381 and 18F-FDG to evaluate and verify that the imaging agent 68Ga-NB381 can safely and effectively identify lesions.
This study will investigate the radioactive uptake of 68Ga-BC1 in lesion sites of multiple myeloma patients and evaluate the ability of 68Ga-BC1 to detect BCMA overexpression in these patients.
According to the admission and exclusion criteria, patients who meet the conditions are screened. After the patients were enrolled, baseline examination information was collected, including blood routine, blood biochemistry, tumour markers, histopathological diagnosis results, imaging diagnosis results, etc.
For the Follow-up information, the patient's bone marrow aspirate or pathological tissue biopsy, laboratory test results (blood monoclonal M protein, 24-hour urine light chain, etc.), bone scintigraphy, CT or MR and other imaging examination results would be collected.
Measured: All PET/CT images will be reviewed by physicians, and a unified diagnostic opinion will be provided within 3 days after adminis. After imaging, patients will be scheduled for follow-up visits every 3 months, with a follow-up period of at least 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start15 Apr 2025
- Primary completion31 Dec 2025 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple Myeloma and Malignant Plasma Cell NeoplasmsStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- This study is an interventional clinical trial in which enrolled patients will undergo a comparative analysis using two PET/CT imaging agents: 68Ga-NB381 and 18F-FDG. The two drugs should be given at least one day apart.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tianyao Wang, Peking University First Hospital
- Investigators
- Lei Kang, M.D., Study chair, Peking University First HospitalYujun Dong Dong, M.D., Study director, Peking University First HospitalTianyao Wang, Ph.D., Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717113
- Sponsor's protocol ID
- PekingUFH-MM-BC1
- Status last verified
- Jun 2025
- First submitted
- 28 Sep 2024
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Some representative clinical trial results will be used for publication in ICMJE journals.
Publications
Kang L, Jiang D, England CG, Barnhart TE, Yu B, Rosenkrans ZT, Wang R, Engle JW, Xu X, Huang P, Cai W. ImmunoPET imaging of CD38 in murine lymphoma models using 89Zr-labeled daratumumab. Eur J Nucl Med Mol Imaging. 2018 Jul;45(8):1372-1381. doi: 10.1007/s00259-018-3941-3. Epub 2018 Feb 15.
PubMed 29450576Kang L, Li C, Rosenkrans ZT, Engle JW, Wang R, Jiang D, Xu X, Cai W. Noninvasive Evaluation of CD20 Expression Using 64Cu-Labeled F(ab')2 Fragments of Obinutuzumab in Lymphoma. J Nucl Med. 2021 Mar;62(3):372-378. doi: 10.2967/jnumed.120.246595. Epub 2020 Aug 21.
PubMed 32826320Kang L, Li C, Yang Q, Sutherlin L, Wang L, Chen Z, Becker KV, Huo N, Qiu Y, Engle JW, Wang R, He C, Jiang D, Xu X, Cai W. 64Cu-labeled daratumumab F(ab')2 fragment enables early visualization of CD38-positive lymphoma. Eur J Nucl Med Mol Imaging. 2022 Apr;49(5):1470-1481. doi: 10.1007/s00259-021-05593-9. Epub 2021 Oct 22.
PubMed 34677626Gu T, Chen Z, Tang B, Wang T, Yang Q, Liu H, Liang Z, Wang Q, Zhang Y, Sun Y, Di M, Yuan T, Qiu Y, Du Y, Song L, Wu S, Wang W, Xu X, Dong Y, Kang L. A single-arm prospective phase I trial of 68Ga-PFBC01 PET/CT for multiple myeloma B cell maturation antigen imaging. J Clin Invest. 2026 Jun 30:e207391. doi: 10.1172/JCI207391. Online ahead of print.
PubMed 42378054
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical PET Imaging Evaluation of 68Ga-BC1 Probe in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06717113
- Acronym / sponsor ID
- PekingUFH-MM-BC1
- Keywords
- multiple myeloma, molecular probe, Immuno-PET
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 4 Dec 2024 (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.
Multiple Myeloma (MM), the second most common hematological malignancy, continues to pose challenges in precise clinical identification. As a potential solution, nuclear medicine immuno-PET imaging has emerged as a promising approach. However, traditional full-length antibody probes suffer from delayed tumor uptake peaks and low target-to-background ratios, limiting their clinical utility. In our study, a peptide or nanobody targeting BCMA was developed by computer-aided designing, which was subsequently radiolabeled with 68Ga to create a novel molecular probe, 68Ga-MM-BC1. This research aims to overcome the diagnostic limitations of MM and may also offer valuable insights for molecular-targeted imaging in other malignant tumors.
Detailed description
Multiple Myeloma (MM) predominantly affects the elderly and often presents insidiously, with most patients being diagnosed at an advanced stage. As China\'s population ages, the incidence of MM is increasing, now surpassing that of acute leukemia. The primary clinical manifestation is bone destruction, which lacks specificity. Diagnosis primarily relies on invasive bone marrow biopsies to detect clonal plasma cell proliferation. However, improper selection of the biopsy site can lead to false-negative results. BCMA is highly expressed on the surface of malignant plasma cells in MM, making it a characteristic tumor biomarker for this disease.
With the rising incidence of malignant tumors in China, there is an increasing demand for radiopharmaceuticals in clinical practice. Given the limitations of 18F-FDG in PET imaging, particularly regarding specificity, the development of novel targeted nuclear medicine molecular probes holds significant academic and clinical value. This is especially true for monitoring the therapeutic effects of peptide or nanobody-based treatments targeting BCMA, which offers distinct advantages. This project focuses on utilizing a peptide or nanobody with high affinity for BCMA as the targeting group for radiopharmaceuticals, exploring the diagnostic efficacy of 68Ga-BC1 in MM patients with high BCMA expression. This approach not only aids in the early diagnosis of MM but also helps tailor effective precision treatments for patients based on their BCMA expression levels.
68Ga-BC1, a novel BCMA-targeting molecular probe labeled with 68Ga, has potential applications in the diagnosis and research of various BCMA-expressing malignancies, including MM. 68Ga-BC1 is synthesized using THP as a bifunctional chelator to coordinate with 68Ga^3+, and the labelling process is simple, allowing for direct use without purification. It demonstrates high in vivo stability and significant tumor uptake in tumor-bearing mice, with superior imaging performance. In this project, the automated labelling process of 68Ga-BC1 will be studied, and quality control measures for the resulting radiopharmaceutical injection will be established. A quality standard for this new PET probe will be set, laying the groundwork for the clinical translation of this drug within China. This study aims to provide valuable data on 68Ga-BC1 PET/CT imaging, offering insights for the early diagnosis, treatment planning, and efficacy evaluation of patients with BCMA-expressing malignancies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is an interventional clinical trial in which enrolled patients will undergo a comparative analysis using two PET/CT imaging agents: 68Ga-NB381 and 18F-FDG. The two drugs should be given at least one day apart.
| Arm | Type | Receives |
|---|---|---|
| 68Ga-BC1 PET/CT diagnosis | Experimental | Drug: 68Ga-BC1 |
| 18F-FDG PET/CT diagnosis | Active comparator | Drug: 18F-FDG |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Suspected multiple myeloma patients scheduled for bone marrow aspiration or tissue biopsy within the past 3 months; able to fully understand and voluntarily participate in the study, with signed informed consent; able to cooperate with the examination.
- Diagnosed symptomatic multiple myeloma patients; able to fully understand and voluntarily participate in the study, with signed informed consent; able to cooperate with the examination.
Key exclusion criteria (1 listed)
- Pregnant women; individuals unable to understand the examination process or who are unable to cooperate.
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 |
|---|---|---|
| 18F-FDGPrior to the examination, patients will be required to fast for at least 6 hours. 18F-FDG (0.05-0.1 mCi/kg) will be intravenously injected, and one hour after the injection, head and torso imaging will be performed using a Shanghai United Imaging uMI 780 PET/CT scanner, covering the region from the top of the head to the upper third of the thigh. The patient will lie supine and breathe calmly during the procedure. After image acquisition, the data will be reconstructed using the OSEM method to generate coronal, sagittal, transverse, and PET/CT fusion images. | Drug | 18F-FDG PET/CT diagnosis |
| 68Ga-BC1The prepared and quality-controlled 68Ga-BC1 (0.05-0.1 mCi/kg) will be intravenously injected into the patient. Two hours after the injection, whole-body imaging will be performed using a Shanghai United Imaging uMI 780 PET/CT scanner, covering the region from the top of the head to the mid-thigh. If any indeterminate lesions are found during the routine imaging, delayed imaging will be performed for further differentiation. The patient will lie supine and breathe calmly during the procedure. After image acquisition, the data will be reconstructed using the OSEM method to generate coronal, sagittal, transverse, and PET/CT fusion images. | Drug | 68Ga-BC1 PET/CT diagnosis |
Primary outcome
MM patients will be recruited to undergo PET/CT imaging using 68Ga-NB381 and 18F-FDG to evaluate and verify that the imaging agent 68Ga-NB381 can safely and effectively identify lesions.
Time frame: All PET/CT images will be reviewed by physicians, and a unified diagnostic opinion will be provided within 3 days after adminis. After imaging, patients will be scheduled for follow-up visits every 3 months, with a follow-up period of at least 12 months.
This study will investigate the radioactive uptake of 68Ga-BC1 in lesion sites of multiple myeloma patients and evaluate the ability of 68Ga-BC1 to detect BCMA overexpression in these patients. According to the admission and exclusion criteria, patients who meet the conditions are screened. After the patients were enrolled, baseline examination information was collected, including blood routine, blood biochemistry, tumour markers, histopathological diagnosis results, imaging diagnosis results, etc. For the Follow-up information, the patient's bone marrow aspirate or pathological tissue biopsy, laboratory test results (blood monoclonal M protein, 24-hour urine light chain, etc.), bone scintigraphy, CT or MR and other imaging examination results would be collected.
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 6 Jun 2025.
- Background: PubMed 29450576Kang L, Jiang D, England CG, Barnhart TE, Yu B, Rosenkrans ZT, Wang R, Engle JW, Xu X, Huang P, Cai W. ImmunoPET imaging of CD38 in murine lymphoma models using 89Zr-labeled daratumumab. Eur J Nucl Med Mol Imaging. 2018 Jul;45(8):1372-1381. doi: 10.1007/s00259-018-3941-3. Epub 2018 Feb 15.
- Background: PubMed 32826320Kang L, Li C, Rosenkrans ZT, Engle JW, Wang R, Jiang D, Xu X, Cai W. Noninvasive Evaluation of CD20 Expression Using 64Cu-Labeled F(ab')2 Fragments of Obinutuzumab in Lymphoma. J Nucl Med. 2021 Mar;62(3):372-378. doi: 10.2967/jnumed.120.246595. Epub 2020 Aug 21.
- Background: PubMed 34677626Kang L, Li C, Yang Q, Sutherlin L, Wang L, Chen Z, Becker KV, Huo N, Qiu Y, Engle JW, Wang R, He C, Jiang D, Xu X, Cai W. 64Cu-labeled daratumumab F(ab')2 fragment enables early visualization of CD38-positive lymphoma. Eur J Nucl Med Mol Imaging. 2022 Apr;49(5):1470-1481. doi: 10.1007/s00259-021-05593-9. Epub 2021 Oct 22.
- Derived from this study: PubMed 42378054Gu T, Chen Z, Tang B, Wang T, Yang Q, Liu H, Liang Z, Wang Q, Zhang Y, Sun Y, Di M, Yuan T, Qiu Y, Du Y, Song L, Wu S, Wang W, Xu X, Dong Y, Kang L. A single-arm prospective phase I trial of 68Ga-PFBC01 PET/CT for multiple myeloma B cell maturation antigen imaging. J Clin Invest. 2026 Jun 30:e207391. doi: 10.1172/JCI207391. Online ahead of print.
- Individual participant dataSharing planned: Yes. Some representative clinical trial results will be used for publication in ICMJE journals.
Related trials for Multiple Myeloma and Malignant Plasma Cell Neoplasms
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 3
Wisconsin Ginseng for Decreasing Cancer Related Fatigue
Malignant Solid Neoplasm, Chronic Lymphocytic Leukemia
Active, not recruitingPhase 2
Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Exon 14 Deletion Genetic Changes (MATCH - Subprotocol C2)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 2
Testing GDC-0449 (Vismodegib) as Potentially Targeted Treatment in Cancers With Smoothened or Patched 1 Mutant Tumors (MATCH - Subprotocol T)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 2
Testing BVD-523FB (Ulixertinib) as Potentially Targeted Treatment in Cancers With Genetic Changes (MATCH - Subprotocol Z1L)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
Lei Kang, M.D. study chair
Peking University First Hospital
Yujun Dong Dong, M.D. study director
Peking University First Hospital
Tianyao Wang, Ph.D. principal investigator
Peking University First Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 18F-FDG and 68Ga-BC1 in people with Multiple Myeloma and Malignant Plasma Cell Neoplasms, run by Peking University First Hospital at 2 sites 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 2 inclusion and 1 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 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Tianyao Wang, PhD (9298551137, tianyao.wang@pkufh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MM patients will be recruited to undergo PET/CT imaging using 68Ga-NB381 and 18F-FDG to evaluate and verify that the imaging agent 68Ga-NB381 can safely and effectively identify lesions. (time frame: All PET/CT images will be reviewed by physicians, and a unified diagnostic opinion will be provided within 3 days after adminis. After imaging, patients will be scheduled for follow-up visits every 3 months, with a follow-up period of at least 12 months.). 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 NCT06717113, which also lists 4 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 6 Jun 2025.