Non-small Cell Lung CancerPhase 1NCT02570815
Near-Infrared Fluorescence Guided Robotic Pulmonary Segmentectomy for Early Stage Lung Cancer
A Phase 1 study testing indocyanine green in people with Non-small Cell Lung Cancer, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
Lungs are made up of individual lobes. When a lung cancer tumour is detected in one of these lobes, surgeons typically perform a Lobectomy. A Lobectomy is the surgery most commonly done to treat early-stage lung cancer and requires removal of an entire lobe of the lung, which removes a large amount of lung tissue For… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- indocyanine green
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to Dec 2026
- Phase
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Tumor size <3 cm
- Clinical Stage 1 Non-Small Cell Lung Cancer (NSCLC)
- CT-imaging confirming that the tumour is confined to the one broncho-pulmonary segment, rendering the patient a candidate for segmental resection.
Who cannot join
- Hypersensitivity or allergy to ICG, sodium iodide or iodine
- Women who are currently pregnant or are breast feeding; or women of child bearing potential who are not currently taking adequate birth control.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Lisa Patterson, 905-522-1155 ext. 35096, pattersl@stjoes.ca
About this study
Official title: Near-Infrared Fluorescence Guided Robotic Pulmonary Segmentectomy for Early Stage Lung Cancer: Analysis of Accuracy and Added Value
Lungs are made up of individual lobes. When a lung cancer tumour is detected in one of these lobes, surgeons typically perform a Lobectomy. A Lobectomy is the surgery most commonly done to treat early-stage lung cancer and requires removal of an entire lobe of the lung, which removes a large amount of lung tissue For patients with small tumours saving as much healthy lung tissue as possible is important. Each lobe of the lung has smaller sections called segments. When a lung cancer is in one of these segments, it is possible to remove that segment, without removing the entire lobe. This surgery is called a segmentectomy. Compared to a lobectomy, a segmentectomy saves a larger amount of healthy lung tissue.
With the advances in screening technology for lung cancer tumours, an increasing amount of very small lung cancer tumours are being found, and the demand for segmentectomy is increasing. A segmentectomy is a hard surgery to perform robotically because it is difficult to view the tissue lines that separate each segment within the lobe. As a result, it is difficult for the surgeon to see exactly which pieces of tissue should be removed. Because of these challenges, many patients having robotic surgery will have a lobectomy, even if a full lobectomy is not needed.
Near-Infrared Fluorescence (NIF) using indocyanine green (ICG) fluorescent dye is a recent advancement in the robotic platform of robotic surgery. The surgeon will view the CT scan to determine which segment the tumour is located in. Once identified, the surgeon will isolate the segment by cutting off the blood supply to that segment. Then ICG will be injected into a vein. It is expected that the entire lung, except the isolated segment, which will remain 'dark' as it was isolated from blood supply, will fluoresce, giving off a green hue when viewed with the da Vinci Firefly camera. The surgeon will identify 'dark' segment, and will remove it. A pathologist will examine the excised tissue to ensure that the tumour was removed in its entirety. Once confirmed, the surgeon will end the procedure. If the pathologist determines that the segment removed did not contain the entire tumour, then the surgeon will perform a routine lobectomy. This ensures patient safety and confirms that all participants will have the entire tumour removed from their lung.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- indocyanine green
- Keywords
- lung cancer, segmentectomy, robotic surgery, near-infrared fluorescent, IC-GREEN, indocyanine green, early-stage lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indocyanine greenDrug
Also called IC-GREEN
ICG will be prepared as a sterile solution (2.5 mg/10mL) for injection. After vascular ligation, a 6 to 8mL bolus of ICG solution will be injected into the peripheral vein catheter, followed by a 10mL saline solution bolus. The Firefly camera will then be used for the NIF imaging. It is expected that the entire lung, except the segment which was previously isolated from blood supply, will fluoresce within 30-40 seconds, exhibiting a green hue. The surgeon will perform the pulmonary resection and the resected 'dark' lung segment will be immediately evaluated by a pathologist, depending on the pathologist findings the operation may be concluded or the patient will receive a pulmonary lobectomy.
| Study group | Role | What they receive |
|---|---|---|
| indocyanine green | Experimental | Non-toxic, fluorescent dye Receives: Drug: indocyanine green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of using NIF-guidance in robotic pulmonary segmentectomy for early-stage lung cancer will be evaluated using items 1, 2, and 3 of a 7-item binary rating scale. An score of 3/7 for these items will indicate success.
Item 1: Visualization of fluoresced lung by NIF imaging; Item 2:Demarcation of a dark segment and inter-segmental plane; Item 3: Completion of segmental resection along the borders of the dark-segmental plane.
Measured: 1 year
Secondary outcomes (14)
Safety will be measured by the rate of adverse reactions to ICG dye as defined by the Ottawa Thoracic Morbidity and Mortality classification
Measured: 1 year
Safety will also be measured by the rate of perioperative complications as defined by the Ottawa Thoracic Morbidity and Mortality classification
Measured: 1 year
Anatomical accuracy will be evaluated using items 4, 5, and 6 of the Indocyanine Green Segmentectomy 7-Item Binary Scale. A score of 3/7 on these items will indicate success of anatomical accuracy
Item 4: Ex-vivo localization of lesions; Item 5: Ex-vivo confirmation of tumor-free margins around lesion; Item 6: Ex-vivo confirmation of adequate anatomical inter-segmental.
Measured: 1 year
Added value of ICG-guidance will be evaluated using Item 7 of the 7-item binary rating scale. A score of 1/7 will indicate added value of ICG-guidance
Item 7: Added value of NIF-guidance
Measured: 1 year
Overall success of the intervention will be evaluated using Items 1-7 of the binary rating scale, only an aggregate score of 7/7 will be considered a success
Measured: 1 year
Reproducibility and validity of the procedure will be measured by the rate of overall success
Measured: 1 year
Partial success of the intervention will be measured by scores between 1/5 and 4/5 on the 7-item binary scale
Measured: 1 year
Length of time of the procedure will be measured by collecting the procedure start and procedure start time
Measured: 1 year
Length of time of the operation will be measured by collecting the time the patient entered the operating room until the time the patient left the operating room
Measured: 1 year
Rate of conversions to lobectomy will be measured by collecting the proportion of conversions to lobectomy or thoracotomy
Measured: 1 year
Rate of conversion to thoracotomy will be measured by collecting the proportion of conversions to thoracotomy
Measured: 1 year
Duration the patient had chest tubes in situ will be measured by collecting the date of surgery and the date the chest tube was removed
Measured: 1 year
Duration of hospital length of stay will be measured by collecting the data of admission and the date of discharge
Measured: 1 year
Learning Curve
Learning curve will be evaluated during the analysis of the data using Items 1-7 of the 7-item binary rating scale, particularly the measured difference (millimeters) in the predicted cautery-marked intersegmental planes delineated prior to using ICG and the true anatomical intersegmental planes delineated with ICG and NIF.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startOct 2016
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wael Hanna, St. Joseph's Healthcare Hamilton
- Investigators
- Waël C. Hanna, MDCM, MBA, FRCSC, Principal investigator, St. Joseph's Healthcare Hamilton / McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570815
- Sponsor's protocol ID
- BFCRS-RP-001-1504-29
- Other IDs
- 101
- Status last verified
- Jan 2026
- First submitted
- 22 Sep 2015
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Landreneau RJ, Sugarbaker DJ, Mack MJ, Hazelrigg SR, Luketich JD, Fetterman L, Liptay MJ, Bartley S, Boley TM, Keenan RJ, Ferson PF, Weyant RJ, Naunheim KS. Wedge resection versus lobectomy for stage I (T1 N0 M0) non-small-cell lung cancer. J Thorac Cardiovasc Surg. 1997 Apr;113(4):691-8; discussion 698-700. doi: 10.1016/S0022-5223(97)70226-5.
PubMed 9104978Zhao X, Qian L, Luo Q, Huang J. Segmentectomy as a safe and equally effective surgical option under complete video-assisted thoracic surgery for patients of stage I non-small cell lung cancer. J Cardiothorac Surg. 2013 Apr 29;8:116. doi: 10.1186/1749-8090-8-116.
PubMed 23628209Pardolesi A, Veronesi G, Solli P, Spaggiari L. Use of indocyanine green to facilitate intersegmental plane identification during robotic anatomic segmentectomy. J Thorac Cardiovasc Surg. 2014 Aug;148(2):737-8. doi: 10.1016/j.jtcvs.2014.03.001. Epub 2014 Mar 5. No abstract available.
PubMed 24680390Finley RJ, Mayo JR, Grant K, Clifton JC, English J, Leo J, Lam S. Preoperative computed tomography-guided microcoil localization of small peripheral pulmonary nodules: a prospective randomized controlled trial. J Thorac Cardiovasc Surg. 2015 Jan;149(1):26-31. doi: 10.1016/j.jtcvs.2014.08.055. Epub 2014 Sep 16.
PubMed 25293355Ivanovic J, Al-Hussaini A, Al-Shehab D, Threader J, Villeneuve PJ, Ramsay T, Maziak DE, Gilbert S, Shamji FM, Sundaresan RS, Seely AJ. Evaluating the reliability and reproducibility of the Ottawa Thoracic Morbidity and Mortality classification system. Ann Thorac Surg. 2011 Feb;91(2):387-93. doi: 10.1016/j.athoracsur.2010.10.035.
PubMed 21256276
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-Infrared Fluorescence Guided Robotic Pulmonary Segmentectomy for Early Stage Lung Cancer: Analysis of Accuracy and Added Value
- ClinicalTrials.gov ID
- NCT02570815
- Acronym / sponsor ID
- BFCRS-RP-001-1504-29
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- lung cancer, segmentectomy, robotic surgery, near-infrared fluorescent, IC-GREEN, indocyanine green, early-stage lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Oct 2015 (estimated)
- 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.
Lungs are made up of individual lobes. When a lung cancer tumour is detected in one of these lobes, surgeons typically perform a Lobectomy. A Lobectomy is the surgery most commonly done to treat early-stage lung cancer and requires removal of an entire lobe of the lung, which removes a large amount of lung tissue For patients with small tumours saving as much healthy lung tissue as possible is important. Each lobe of the lung has smaller sections called segments. When a lung cancer is in one of these segments, it is possible to remove that segment, without removing the entire lobe. This surgery is called a segmentectomy. Compared to a lobectomy, a segmentectomy saves a larger amount of healthy lung tissue.
With the advances in screening technology for lung cancer tumours, an increasing amount of very small lung cancer tumours are being found, and the demand for segmentectomy is increasing. A segmentectomy is a hard surgery to perform robotically because it is difficult to view the tissue lines that separate each segment within the lobe. As a result, it is difficult for the surgeon to see exactly which pieces of tissue should be removed. Because of these challenges, many patients having robotic surgery will have a lobectomy, even if a full lobectomy is not needed.
Near-Infrared Fluorescence (NIF) using indocyanine green (ICG) fluorescent dye is a recent advancement in the robotic platform of robotic surgery. The surgeon will view the CT scan to determine which segment the tumour is located in. Once identified, the surgeon will isolate the segment by cutting off the blood supply to that segment. Then ICG will be injected into a vein. It is expected that the entire lung, except the isolated segment, which will remain 'dark' as it was isolated from blood supply, will fluoresce, giving off a green hue when viewed with the da Vinci Firefly camera. The surgeon will identify 'dark' segment, and will remove it. A pathologist will examine the excised tissue to ensure that the tumour was removed in its entirety. Once confirmed, the surgeon will end the procedure. If the pathologist determines that the segment removed did not contain the entire tumour, then the surgeon will perform a routine lobectomy. This ensures patient safety and confirms that all participants will have the entire tumour removed from their lung.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| indocyanine green | Experimental | Drug: indocyanine greenNon-toxic, fluorescent dye |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Tumor size <3 cm
- Clinical Stage 1 Non-Small Cell Lung Cancer (NSCLC)
- CT-imaging confirming that the tumour is confined to the one broncho-pulmonary segment, rendering the patient a candidate for segmental resection.
Key exclusion criteria (2 listed)
- Hypersensitivity or allergy to ICG, sodium iodide or iodine
- Women who are currently pregnant or are breast feeding; or women of child bearing potential who are not currently taking adequate birth control.
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 |
|---|---|---|
| indocyanine greenAlso: IC-GREENICG will be prepared as a sterile solution (2.5 mg/10mL) for injection. After vascular ligation, a 6 to 8mL bolus of ICG solution will be injected into the peripheral vein catheter, followed by a 10mL saline solution bolus. The Firefly camera will then be used for the NIF imaging. It is expected that the entire lung, except the segment which was previously isolated from blood supply, will fluoresce within 30-40 seconds, exhibiting a green hue. The surgeon will perform the pulmonary resection and the resected 'dark' lung segment will be immediately evaluated by a pathologist, depending on the pathologist findings the operation may be concluded or the patient will receive a pulmonary lobectomy. | Drug | indocyanine green |
Primary outcome
Feasibility of using NIF-guidance in robotic pulmonary segmentectomy for early-stage lung cancer will be evaluated using items 1, 2, and 3 of a 7-item binary rating scale. An score of 3/7 for these items will indicate success.
Time frame: 1 year
Item 1: Visualization of fluoresced lung by NIF imaging; Item 2:Demarcation of a dark segment and inter-segmental plane; Item 3: Completion of segmental resection along the borders of the dark-segmental plane.
14 secondary outcomes
Safety will be measured by the rate of adverse reactions to ICG dye as defined by the Ottawa Thoracic Morbidity and Mortality classification
Time frame: 1 year
Safety will also be measured by the rate of perioperative complications as defined by the Ottawa Thoracic Morbidity and Mortality classification
Time frame: 1 year
Anatomical accuracy will be evaluated using items 4, 5, and 6 of the Indocyanine Green Segmentectomy 7-Item Binary Scale. A score of 3/7 on these items will indicate success of anatomical accuracy
Time frame: 1 year
Added value of ICG-guidance will be evaluated using Item 7 of the 7-item binary rating scale. A score of 1/7 will indicate added value of ICG-guidance
Time frame: 1 year
Overall success of the intervention will be evaluated using Items 1-7 of the binary rating scale, only an aggregate score of 7/7 will be considered a success
Time frame: 1 year
Reproducibility and validity of the procedure will be measured by the rate of overall success
Time frame: 1 year
Partial success of the intervention will be measured by scores between 1/5 and 4/5 on the 7-item binary scale
Time frame: 1 year
Length of time of the procedure will be measured by collecting the procedure start and procedure start time
Time frame: 1 year
Length of time of the operation will be measured by collecting the time the patient entered the operating room until the time the patient left the operating room
Time frame: 1 year
Rate of conversions to lobectomy will be measured by collecting the proportion of conversions to lobectomy or thoracotomy
Time frame: 1 year
Rate of conversion to thoracotomy will be measured by collecting the proportion of conversions to thoracotomy
Time frame: 1 year
Duration the patient had chest tubes in situ will be measured by collecting the date of surgery and the date the chest tube was removed
Time frame: 1 year
Duration of hospital length of stay will be measured by collecting the data of admission and the date of discharge
Time frame: 1 year
Learning Curve
Time frame: 1 year
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 Feb 2026.
- Background: PubMed 9104978Landreneau RJ, Sugarbaker DJ, Mack MJ, Hazelrigg SR, Luketich JD, Fetterman L, Liptay MJ, Bartley S, Boley TM, Keenan RJ, Ferson PF, Weyant RJ, Naunheim KS. Wedge resection versus lobectomy for stage I (T1 N0 M0) non-small-cell lung cancer. J Thorac Cardiovasc Surg. 1997 Apr;113(4):691-8; discussion 698-700. doi: 10.1016/S0022-5223(97)70226-5.
- Background: PubMed 23628209Zhao X, Qian L, Luo Q, Huang J. Segmentectomy as a safe and equally effective surgical option under complete video-assisted thoracic surgery for patients of stage I non-small cell lung cancer. J Cardiothorac Surg. 2013 Apr 29;8:116. doi: 10.1186/1749-8090-8-116.
- Background: PubMed 24680390Pardolesi A, Veronesi G, Solli P, Spaggiari L. Use of indocyanine green to facilitate intersegmental plane identification during robotic anatomic segmentectomy. J Thorac Cardiovasc Surg. 2014 Aug;148(2):737-8. doi: 10.1016/j.jtcvs.2014.03.001. Epub 2014 Mar 5. No abstract available.
- Background: PubMed 25293355Finley RJ, Mayo JR, Grant K, Clifton JC, English J, Leo J, Lam S. Preoperative computed tomography-guided microcoil localization of small peripheral pulmonary nodules: a prospective randomized controlled trial. J Thorac Cardiovasc Surg. 2015 Jan;149(1):26-31. doi: 10.1016/j.jtcvs.2014.08.055. Epub 2014 Sep 16.
- Background: PubMed 21256276Ivanovic J, Al-Hussaini A, Al-Shehab D, Threader J, Villeneuve PJ, Ramsay T, Maziak DE, Gilbert S, Shamji FM, Sundaresan RS, Seely AJ. Evaluating the reliability and reproducibility of the Ottawa Thoracic Morbidity and Mortality classification system. Ann Thorac Surg. 2011 Feb;91(2):387-93. doi: 10.1016/j.athoracsur.2010.10.035.
- Individual participant dataSharing planned: No
Related trials for Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Waël C. Hanna, MDCM, MBA, FRCSC principal investigator
St. Joseph's Healthcare Hamilton / McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing indocyanine green in people with Non-small Cell Lung Cancer, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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 2 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 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 Canada. 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?
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.
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 Lisa L Patterson, BA (905-522-1155, patterls@stjoes.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of using NIF-guidance in robotic pulmonary segmentectomy for early-stage lung cancer will be evaluated using items 1, 2, and 3 of a 7-item binary rating scale. An score of 3/7 for these items will indicate success. (time frame: 1 year). 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 NCT02570815, which also lists 5 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 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.