Lung Cancer (Including Metastatic Cancer)4DCT-FLARNCT07339644
Functional Lung Avoidance Radiotherapy Guided by 4DCT Pulmonary Ventilation Function Imaging: A Prospective Single-arm Clinical Study
A study testing 4DCT Ventilation Imaging-Guided Functional Lung Avoidance Radiotherapy (FLAR) in people with Lung Cancer (Including Metastatic Cancer) and Radiation Pneumonitis, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
This prospective, single-center, single-arm study will evaluate the feasibility and safety of 4DCT ventilation functional imaging-guided functional lung avoidance radiotherapy (FLAR) in patients with lung malignancies receiving IMRT radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Cancer (Including Metastatic Cancer), Radiation Pneumonitis, Radiation-induced Lung Injury
- What is being tested?
- 4DCT Ventilation Imaging-Guided Functional Lung Avoidance Radiotherapy (FLAR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2025to 24 Dec 2027
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 85 years (inclusive); any sex.
- Diagnosed lung malignancy requiring thoracic radiotherapy (e.g., non-small cell lung cancer, small cell lung cancer, or pulmonary metastases).
- Planned to receive thoracic radiotherapy using either conventionally fractionated IMRT/VMAT or stereotactic body radiotherapy (SBRT), and able to complete pre-treatment 4DCT simulation suitable for generating a ventilation map.
- Adequate baseline organ function and clinically judged able to tolerate radiotherapy; ECOG performance status 0-1.
- No absolute contraindication to pulmonary function testing; patients with moderate COPD or impaired lung function may be included if the treating team judges radiotherapy to be tolerable.
- Able to comply with treatment and follow-up assessments.
- Written informed consent provided.
Who cannot join
- Pregnant or breastfeeding women. Women of childbearing potential must have pregnancy excluded prior to radiotherapy per institutional practice.
- Age <18 or >85 years.
- Uncontrolled severe cardiopulmonary disease or other severe comorbidities that make radiotherapy excessively high risk (e.g., decompensated heart failure, unstable cardiopulmonary status, active severe pulmonary infection).
- Prior high-dose thoracic radiotherapy to the same region such that safe re-irradiation is not feasible.
- Concurrent other active/advanced malignancy requiring priority treatment that would confound study outcomes.
- Recent participation in another interventional clinical trial or concurrent investigational therapy judged likely to interfere with this study's endpoints.
Show all 9Show fewer
- Severe psychiatric, cognitive, or other conditions that prevent cooperation with radiotherapy and/or scheduled follow-up.
- Inadequate 4DCT image quality or inability to generate/validate the 4DCT ventilation map required for functional-lung-guided planning.
- Any other condition deemed unsuitable by the investigators in the interest of participant safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Center, Second Affiliated Hospital of Chongqing Medical University
Chongqing, 400000
Xiongying Fang, MD., +86 23 62888436, 1270161476@qq.com
About this study
This prospective, single-center, single-arm study will evaluate the feasibility and safety of 4DCT ventilation functional imaging-guided functional lung avoidance radiotherapy (FLAR) in patients with lung malignancies receiving IMRT radiotherapy.
All participants will undergo 4DCT simulation as part of routine radiotherapy preparation. A ventilation map will be generated from 4DCT data, and the top 80% ventilation region will be defined as the high-function lung. This structure will be imported into the treatment planning system to create an FLAR plan that prioritizes sparing of high-function lung while maintaining target coverage (PTV D95%) and meeting standard dose constraints for organs at risk. A conventional anatomic plan (without functional guidance) will also be created for paired, within-patient dosimetric comparison.
The primary outcome is improvement in dosimetric sparing of the high-function lung (V10, V20, V30, and mean lung dose). Secondary outcomes include the incidence of grade ≥2 radiation pneumonitis (CTCAE v5.0), changes in pulmonary function (e.g., FEV1 and DLCO), and lung-related quality-of-life scores. Assessments will be performed mid-treatment (after 15 fractions), at the end of radiotherapy (after 30 fractions), and at 1, 3, 6, and 12 months after radiotherapy. The study plans to enroll 100 participants and follow each participant for 12 months.
- Conditions
- Lung Cancer (Including Metastatic Cancer), Radiation Pneumonitis, Radiation-induced Lung Injury
- Being tested
- 4DCT Ventilation Imaging-Guided Functional Lung Avoidance Radiotherapy (FLAR)
- Keywords
- Functional lung avoidance radiotherapy, 4DCT ventilation imaging, Functional lung imaging (FLI), Dose-volume histogram (DVH), High-function lung, Radiotherapy planning optimization, Radiation pneumonitis, Pulmonary function
- Medical subject headings
- Lung Neoplasms, Radiation Pneumonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4DCT Ventilation Imaging-Guided Functional Lung Avoidance Radiotherapy (FLAR)Procedure or surgery
Also called Functional Lung Avoidance Radiotherapy, 4DCT-FLAR, 4DCT Ventilation Functional Imaging (4DCT-FLI)-Guided Radiotherapy
All participants undergo 4DCT simulation. A ventilation map is generated from 4DCT data, and the high-function lung is defined as the top 80% ventilation region. This structure is imported into the treatment planning system, and an IMRT plan is optimized to preferentially spare high-function lung while maintaining target (PTV) coverage and meeting standard organ-at-risk constraints. A conventional anatomic plan (without functional guidance) is also created for within-patient paired dosimetric comparison.
| Study group | Role | What they receive |
|---|---|---|
| 4DCT-FLI-Guided Functional Lung Avoidance Radiotherapy (FLAR) | Experimental | Participants receive IMRT planned with 4DCT ventilation functional imaging guidance. A ventilation map is generated from 4DCT, high-function lung (top 80% ventilation) is contoured, and the treatment plan is optimized to spare high-function lung while maintaining target coverage and meeting standard OAR constraints. A conventional anatomic plan is also generated for within-patient dosimetric comparison. Receives: Procedure: 4DCT Ventilation Imaging-Guided Functional Lung Avoidance Radiotherapy (FLAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Radiation-Induced Lung Injury (Grade ≥2)
Incidence of radiation-induced lung injury (RILI) of Grade ≥ 2, assessed using the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
CTCAE grades range from Grade 1 (mild) to Grade 5 (death related to adverse event), with higher grades indicating more severe toxicity.
The primary outcome is the proportion of patients experiencing CTCAE Grade ≥ 2 RILI.
Measured: Time Frame: Assessed at 3 months, 6 months, and 12 months after completion of radiotherapy.
Secondary outcomes (14)
Mean Dose to High-Function Lung (Gy)
DVH-derived mean dose to ventilation-defined high-function lung on paired plans (functional-lung-avoidance vs conventional plans). Lower dose indicates better sparing.
Measured: At baseline treatment planning (prior to radiotherapy delivery).]
MLD for Whole Lung (Gy)
Percentage volume (%) of ventilation-defined high-function lung receiving ≥5 Gy, reported separately for functional-lung-avoidance and conventional radiotherapy plans.
Measured: At baseline treatment planning (prior to radiotherapy delivery).
V5 of High-Function Lung (%)
Percentage volume (%) of ventilation-defined high-function lung receiving ≥5 Gy, reported separately for functional-lung-avoidance and conventional radiotherapy plans.
Measured: At baseline treatment planning (prior to radiotherapy delivery).
V20 of High-Function Lung（%）
DVH-derived V20 of ventilation-defined high-function lung, defined as the percentage of lung volume receiving ≥20 Gy, compared between functional-lung-avoidance and conventional radiotherapy plans.
Measured: At baseline treatment planning (prior to radiotherapy delivery).
Mean Dose to Heart (Gy)
DVH-derived mean dose (Dmean) to the heart, compared between functional-lung-avoidance and conventional radiotherapy plans.
Measured: At treatment planning (baseline, pre-radiotherapy delivery).
Maximum Dose to Esophagus (Gy)
DVH-derived maximum dose (Dmax) to the esophagus, compared between functional-lung-avoidance and conventional radiotherapy plans.
Measured: At treatment planning (baseline, pre-radiotherapy delivery).]
Maximum Dose to Spinal Cord (Gy)
DVH-derived maximum dose (Dmax) to the spinal cord, compared between functional-lung-avoidance and conventional radiotherapy plans.
Measured: At treatment planning (baseline, pre-radiotherapy delivery).
Target Coverage (PTV D95)
Percentage of planning target volume (PTV) receiving at least 95% of prescribed dose, compared between functional-lung-avoidance and conventional plans.
Measured: At treatment planning (baseline, pre-radiotherapy delivery).
Conformity Index of Radiotherapy Plans
Conformity Index (CI) of paired treatment plans, comparing functional-lung-avoidance and conventional anatomic radiotherapy plans.
The Conformity Index is defined as the ratio of the prescription isodose volume to the target volume (CI = VRI / VT).
The score ranges from 1.0 to >2.0, where a value closer to 1.0 indicates better conformity and thus higher plan quality.
Measured: At treatment planning (baseline, pre-radiotherapy delivery).
Homogeneity Index of Radiotherapy Plans
Homogeneity Index (HI) of paired treatment plans, comparing functional-lung-avoidance and conventional anatomic radiotherapy plans.
The Homogeneity Index is defined as (D2% - D98%) / D50%.
The score typically ranges from 0 to 1.0, where lower values indicate more homogeneous dose distribution and better plan quality.
Measured: At treatment planning (baseline, pre-radiotherapy delivery).
Gradient Measure (GM) of Radiotherapy Plans
Gradient Measure (cm) of paired radiotherapy plans, comparing 4DCT-FLI-guided functional lung avoidance plans and conventional anatomic plans. GM is defined as the difference between the equivalent sphere radii of the 50% and 100% prescription isodose volumes (GM = R50% - R100%); lower values indicate steeper dose fall-off and better plan quality.
Measured: At treatment planning (baseline, pre-radiotherapy delivery).
Forced Expiratory Volume in 1 Second (FEV1)
FEV1 measured by standardized spirometry (L and % predicted). Outcome is change from baseline.
Measured: Baseline and 1, 3, 6, and 12 months after radiotherapy.
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
DLCO measured using a standardized single-breath method (mL/min/mmHg and % predicted). Outcome is change from baseline.
Measured: Baseline and 1, 3, 6, and 12 months after radiotherapy.
Forced Vital Capacity (FVC)
FVC measured by standardized spirometry (L and % predicted). Outcome is change from baseline.
Measured: Baseline and 1, 3, 6, and 12 months after radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start24 Oct 2025
- Primary completion24 Dec 2026 (estimated)
- Study completion24 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer (Including Metastatic Cancer)Studies 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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, single-center prospective study. All participants receive 4DCT ventilation imaging-guided functional lung avoidance radiotherapy (FLAR). For within-patient paired dosimetric comparison, a conventional anatomic plan (non-functional plan) is also generated for each participant.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZhenZhou Yang, The Second Affiliated Hospital of Chongqing Medical University
- Investigators
- zhengjun Guo, MD., Principal investigator, The Second Clinical College of Chongqing Medical University: The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339644
- Sponsor's protocol ID
- IRB-2025-243
- Acronym
- 4DCT-FLAR
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vinogradskiy Y, Castillo R, Castillo E, Tucker SL, Liao Z, Guerrero T, Martel MK. Use of 4-dimensional computed tomography-based ventilation imaging to correlate lung dose and function with clinical outcomes. Int J Radiat Oncol Biol Phys. 2013 Jun 1;86(2):366-71. doi: 10.1016/j.ijrobp.2013.01.004. Epub 2013 Mar 6.
PubMed 23474113
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Lung Avoidance Radiotherapy Guided by 4DCT Pulmonary Ventilation Function Imaging: A Prospective Single-arm Clinical Study
- ClinicalTrials.gov ID
- NCT07339644
- Acronym / sponsor ID
- 4DCT-FLAR / IRB-2025-243
- Conditions
- Lung Cancer (Including Metastatic Cancer), Radiation Pneumonitis, Radiation-induced Lung Injury
- Keywords
- Functional lung avoidance radiotherapy, 4DCT ventilation imaging, Functional lung imaging (FLI), Dose-volume histogram (DVH), High-function lung, Radiotherapy planning optimization, Radiation pneumonitis, Pulmonary function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- 24 Dec 2026 (estimated)
- Study completion
- 24 Dec 2027 (estimated)
- First posted
- 14 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.
This prospective, single-center, single-arm study will evaluate the feasibility and safety of 4DCT ventilation functional imaging-guided functional lung avoidance radiotherapy (FLAR) in patients with lung malignancies receiving IMRT radiotherapy.
All participants will undergo 4DCT simulation as part of routine radiotherapy preparation. A ventilation map will be generated from 4DCT data, and the top 80% ventilation region will be defined as the high-function lung. This structure will be imported into the treatment planning system to create an FLAR plan that prioritizes sparing of high-function lung while maintaining target coverage (PTV D95%) and meeting standard dose constraints for organs at risk. A conventional anatomic plan (without functional guidance) will also be created for paired, within-patient dosimetric comparison.
The primary outcome is improvement in dosimetric sparing of the high-function lung (V10, V20, V30, and mean lung dose). Secondary outcomes include the incidence of grade ≥2 radiation pneumonitis (CTCAE v5.0), changes in pulmonary function (e.g., FEV1 and DLCO), and lung-related quality-of-life scores. Assessments will be performed mid-treatment (after 15 fractions), at the end of radiotherapy (after 30 fractions), and at 1, 3, 6, and 12 months after radiotherapy. The study plans to enroll 100 participants and follow each participant for 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, single-center prospective study. All participants receive 4DCT ventilation imaging-guided functional lung avoidance radiotherapy (FLAR). For within-patient paired dosimetric comparison, a conventional anatomic plan (non-functional plan) is also generated for each participant.
| Arm | Type | Receives |
|---|---|---|
| 4DCT-FLI-Guided Functional Lung Avoidance Radiotherapy (FLAR) | Experimental | Procedure: 4DCT Ventilation Imaging-Guided Functional Lung Avoidance Radiotherapy (FLAR)Participants receive IMRT planned with 4DCT ventilation functional imaging guidance. A ventilation map is generated from 4DCT, high-function lung (top 80% ventilation) is contoured, and the treatment plan is optimized to spare high-function lung while maintaining target coverage and meeting standard OAR constraints. A conventional anatomic plan is also generated for within-patient dosimetric comparison. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 85 years (inclusive); any sex.
- Diagnosed lung malignancy requiring thoracic radiotherapy (e.g., non-small cell lung cancer, small cell lung cancer, or pulmonary metastases).
- Planned to receive thoracic radiotherapy using either conventionally fractionated IMRT/VMAT or stereotactic body radiotherapy (SBRT), and able to complete pre-treatment 4DCT simulation suitable for generating a ventilation map.
- Adequate baseline organ function and clinically judged able to tolerate radiotherapy; ECOG performance status 0-1.
- No absolute contraindication to pulmonary function testing; patients with moderate COPD or impaired lung function may be included if the treating team judges radiotherapy to be tolerable.
Key exclusion criteria (9 listed)
- Pregnant or breastfeeding women. Women of childbearing potential must have pregnancy excluded prior to radiotherapy per institutional practice.
- Age <18 or >85 years.
- Uncontrolled severe cardiopulmonary disease or other severe comorbidities that make radiotherapy excessively high risk (e.g., decompensated heart failure, unstable cardiopulmonary status, active severe pulmonary infection).
- Prior high-dose thoracic radiotherapy to the same region such that safe re-irradiation is not feasible.
- Concurrent other active/advanced malignancy requiring priority treatment that would confound study outcomes.
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 |
|---|---|---|
| 4DCT Ventilation Imaging-Guided Functional Lung Avoidance Radiotherapy (FLAR)Also: Functional Lung Avoidance Radiotherapy, 4DCT-FLAR, 4DCT Ventilation Functional Imaging (4DCT-FLI)-Guided RadiotherapyAll participants undergo 4DCT simulation. A ventilation map is generated from 4DCT data, and the high-function lung is defined as the top 80% ventilation region. This structure is imported into the treatment planning system, and an IMRT plan is optimized to preferentially spare high-function lung while maintaining target (PTV) coverage and meeting standard organ-at-risk constraints. A conventional anatomic plan (without functional guidance) is also created for within-patient paired dosimetric comparison. | Procedure or surgery | 4DCT-FLI-Guided Functional Lung Avoidance Radiotherapy (FLAR) |
Primary outcome
Incidence of Radiation-Induced Lung Injury (Grade ≥2)
Time frame: Time Frame: Assessed at 3 months, 6 months, and 12 months after completion of radiotherapy.
Incidence of radiation-induced lung injury (RILI) of Grade ≥ 2, assessed using the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0. CTCAE grades range from Grade 1 (mild) to Grade 5 (death related to adverse event), with higher grades indicating more severe toxicity. The primary outcome is the proportion of patients experiencing CTCAE Grade ≥ 2 RILI.
14 secondary outcomes
Mean Dose to High-Function Lung (Gy)
Time frame: At baseline treatment planning (prior to radiotherapy delivery).]
MLD for Whole Lung (Gy)
Time frame: At baseline treatment planning (prior to radiotherapy delivery).
V5 of High-Function Lung (%)
Time frame: At baseline treatment planning (prior to radiotherapy delivery).
V20 of High-Function Lung（%）
Time frame: At baseline treatment planning (prior to radiotherapy delivery).
Mean Dose to Heart (Gy)
Time frame: At treatment planning (baseline, pre-radiotherapy delivery).
Maximum Dose to Esophagus (Gy)
Time frame: At treatment planning (baseline, pre-radiotherapy delivery).]
Maximum Dose to Spinal Cord (Gy)
Time frame: At treatment planning (baseline, pre-radiotherapy delivery).
Target Coverage (PTV D95)
Time frame: At treatment planning (baseline, pre-radiotherapy delivery).
Conformity Index of Radiotherapy Plans
Time frame: At treatment planning (baseline, pre-radiotherapy delivery).
Homogeneity Index of Radiotherapy Plans
Time frame: At treatment planning (baseline, pre-radiotherapy delivery).
Gradient Measure (GM) of Radiotherapy Plans
Time frame: At treatment planning (baseline, pre-radiotherapy delivery).
Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline and 1, 3, 6, and 12 months after radiotherapy.
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Time frame: Baseline and 1, 3, 6, and 12 months after radiotherapy.
Forced Vital Capacity (FVC)
Time frame: Baseline and 1, 3, 6, and 12 months after radiotherapy.
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 9 Feb 2026.
- Results publication: PubMed 23474113Vinogradskiy Y, Castillo R, Castillo E, Tucker SL, Liao Z, Guerrero T, Martel MK. Use of 4-dimensional computed tomography-based ventilation imaging to correlate lung dose and function with clinical outcomes. Int J Radiat Oncol Biol Phys. 2013 Jun 1;86(2):366-71. doi: 10.1016/j.ijrobp.2013.01.004. Epub 2013 Mar 6.
- 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.
zhengjun Guo, MD. principal investigator
The Second Clinical College of Chongqing Medical University: The Second Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4DCT Ventilation Imaging-Guided Functional Lung Avoidance Radiotherapy (FLAR) in people with Lung Cancer (Including Metastatic Cancer) and Radiation Pneumonitis, run by The Second Affiliated Hospital of Chongqing Medical University 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 7 inclusion and 9 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 9 Feb 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 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.
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 Zhi chen, MD. (+86 18982928222, 2023440076@stu.cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Radiation-Induced Lung Injury (Grade ≥2) (time frame: Time Frame: Assessed at 3 months, 6 months, and 12 months after completion of radiotherapy.). 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 NCT07339644, which also lists 1 linked publication.
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 9 Feb 2026.