Detection Rate of SLN ; Accuracy Rate of Lymph Node MetastasisPhase 1NCT04173676
Sentinel Lymph Node Navigation Surgery Using Near-infrared Imaging in Early Esophageal Cancer
A Phase 1 study testing Indocyanine Green for Injection in people with Detection Rate of SLN ; Accuracy Rate of Lymph Node Metastasis, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The esophageal squamous cell carcinoma (ESCC) has high prevalence and mortality in China, which become a severe challenge for public health. Esophagectomy is the preferred choice for the patients who are diagnosed with ESCC in early stage .Although three-field lymphadenectomy has improved patient survival and reduced… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Detection Rate of SLN ; Accuracy Rate of Lymph Node Metastasis
- What is being tested?
- Indocyanine Green for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 2 Dec 2019to 30 Nov 2021
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old ≤ age ≤ 75 years old, gender is not limited;
- patient who is diagnosed with ESCC and choose to proceed with surgery
- patient with cTNM stage:T1-3N0-1M0
- tumor located at the middle thoracic or lower thoracic esophagus
- The main organ function is basically normal: Karnofsky score >70%;
- Laboratory blood tests meet surgical standards;
Who cannot join
- pregnancy or breastfeeding
- history of iodide or seafood allergy,
- Patient with occult metastatic disease at the time of surgery
- patient with mental disorder;
- Patient who is simultaneously involved in another clinical trial;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, 519000
Xiaojin Wang, MD, +86-13798967219, wangxj55@mail.sysu.edu.cn
About this study
Official title: Sentinel Lymph Node Navigation Using Near-infrared Imaging in Radical Esophagectomy Surgery ：a Single-arm Clinical Trial
The esophageal squamous cell carcinoma (ESCC) has high prevalence and mortality in China, which become a severe challenge for public health. Esophagectomy is the preferred choice for the patients who are diagnosed with ESCC in early stage .Although three-field lymphadenectomy has improved patient survival and reduced tumor recurrence, Surgery-related complications increased dramatically.
It has become a research hotspot to find an effective detection method to identify the lymph node metastasis of ESCC and avoid ineffective expanded lymphadenectomy .The molecular imaging technology has been developed for intra-operative visualization and precise resection of the tumors.
Read more
Indocyanine Green for Injection (ICG) has been used as a contrast agent in the near-infrared imaging system for the surgical navigation technology, which has a relatively positive effect in the clinical application of gastric cancer and liver cancer.There are few reports on the application of ICG near-infrared imaging tracer lymph nodes in the surgery of ESCC. This study intends to identify the detection rate of sentinel lymph node (SLN) and determine the accuracy of regional lymph node metastasis in ESCC by ICG near-infrared imaging technique, which provides clinical evidence for subsequent precise resection of the lymph nodes.
This will be one-arm prospective trial. The ESCC patients will be recruited with strict criteria. 84 patients will be enrolled between18 and 75 years old, without gender limit. The submucosal injection of ICG will be performed preoperatively by gastroscopy on the superior and inferior edge of the esophageal tumor. NIR fluorescence imaging will be performed intraoperatively to observe the lymph nodes. The luminescent lymph node is defined as SLN. According to the standard procedure, 3 field lymphadenectomy will be performed, and all the resected lymph nodes will be subjected to pathological analysis including correlation study of fluorescence signal and tumor tissue in pathology slice.
This clinical trial is anticipated to evaluate the detection rate of SLN in ESCC with ICG near-infrared fluorescence imaging and determine the accuracy of regional lymph node metastasis.
- Being tested
- Indocyanine Green for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine Green for InjectionDrug
The sentinel lymph nodes were observed by submucosal injection of ICG
| Study group | Role | What they receive |
|---|---|---|
| use of indocyanine green | Experimental | submucosal injection of ICG is by gastroscopy on the superior and inferior edge of the esophageal tumor,Dose of 0.5mg Receives: Drug: Indocyanine Green for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
the detection rate of sentinel lymph node
the detection rate of sentinel lymph node in all the enrolled patients
Measured: through study completion, an average of 1 year
The positive rate of sentinel lymph node
the positive rate of sentinel lymph node in all the enrolled patients
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start2 Dec 2019
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Detection Rate of SLN ; Accuracy Rate of Lymph Node MetastasisStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The sentinel lymph nodes are observed by submucosal injection of ICG
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173676
- Sponsor's protocol ID
- No.ZDWY[2018]LunziNo.(K31-1)
- Status last verified
- May 2020
- First submitted
- 17 Nov 2019
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shirakawa S, Toyama H, Kido M, Fukumoto T. A prospective single-center protocol for using near-infrared fluorescence imaging with indocyanine green during staging laparoscopy to detect small metastasis from pancreatic cancer. BMC Surg. 2019 Nov 7;19(1):165. doi: 10.1186/s12893-019-0635-0.
PubMed 31699083Lim HJ, Chiow AKH, Lee LS, Tan SS, Goh BK, Koh YX, Chan CY, Lee SY. Novel method of intraoperative liver tumour localisation with indocyanine green and near-infrared imaging. Singapore Med J. 2021 Apr;62(4):182-189. doi: 10.11622/smedj.2019137. Epub 2019 Nov 4.
PubMed 31680180Yanagi Y, Yoshimaru K, Matsuura T, Shibui Y, Kohashi K, Takahashi Y, Obata S, Sozaki R, Izaki T, Taguchi T. The outcome of real-time evaluation of biliary flow using near-infrared fluorescence cholangiography with Indocyanine green in biliary atresia surgery. J Pediatr Surg. 2019 Dec;54(12):2574-2578. doi: 10.1016/j.jpedsurg.2019.08.029. Epub 2019 Sep 2.
PubMed 31575415Hayami S, Matsuda K, Iwamoto H, Ueno M, Kawai M, Hirono S, Okada K, Miyazawa M, Tamura K, Mitani Y, Kitahata Y, Mizumoto Y, Yamaue H. Visualization and quantification of anastomotic perfusion in colorectal surgery using near-infrared fluorescence. Tech Coloproctol. 2019 Oct;23(10):973-980. doi: 10.1007/s10151-019-02089-5. Epub 2019 Sep 18.
PubMed 31535238Zhou SC, Tian YT, Wang XW, Zhao CD, Ma S, Jiang J, Li EN, Zhou HT, Liu Q, Liang JW, Zhou ZX, Wang XS. Application of indocyanine green-enhanced near-infrared fluorescence-guided imaging in laparoscopic lateral pelvic lymph node dissection for middle-low rectal cancer. World J Gastroenterol. 2019 Aug 21;25(31):4502-4511. doi: 10.3748/wjg.v25.i31.4502.
PubMed 31496628Yamada Y, Ohno M, Fujino A, Kanamori Y, Irie R, Yoshioka T, Miyazaki O, Uchida H, Fukuda A, Sakamoto S, Kasahara M, Matsumoto K, Fuchimoto Y, Hoshino K, Kuroda T, Hishiki T. Fluorescence-Guided Surgery for Hepatoblastoma with Indocyanine Green. Cancers (Basel). 2019 Aug 20;11(8):1215. doi: 10.3390/cancers11081215.
PubMed 31434361Predina JD, Newton AD, Corbett C, Shin M, Sulfyok LF, Okusanya OT, Delikatny EJ, Nie S, Gaughan C, Jarrar D, Pechet T, Kucharczuk JC, Singhal S. Near-infrared intraoperative imaging for minimally invasive pulmonary metastasectomy for sarcomas. J Thorac Cardiovasc Surg. 2019 May;157(5):2061-2069. doi: 10.1016/j.jtcvs.2018.10.169. Epub 2018 Dec 14.
PubMed 31288365Pennathur A, Gibson MK, Jobe BA, Luketich JD. Oesophageal carcinoma. Lancet. 2013 Feb 2;381(9864):400-12. doi: 10.1016/S0140-6736(12)60643-6.
PubMed 23374478Rice TW, Apperson-Hansen C, DiPaola LM, Semple ME, Lerut TE, Orringer MB, Chen LQ, Hofstetter WL, Smithers BM, Rusch VW, Wijnhoven BP, Chen KN, Davies AR, D'Journo XB, Kesler KA, Luketich JD, Ferguson MK, Rasanen JV, van Hillegersberg R, Fang W, Durand L, Allum WH, Cecconello I, Cerfolio RJ, Pera M, Griffin SM, Burger R, Liu JF, Allen MS, Law S, Watson TJ, Darling GE, Scott WJ, Duranceau A, Denlinger CE, Schipper PH, Ishwaran H, Blackstone EH. Worldwide Esophageal Cancer Collaboration: clinical staging data. Dis Esophagus. 2016 Oct;29(7):707-714. doi: 10.1111/dote.12493.
PubMed 27731549Lerut T, Nafteux P, Moons J, Coosemans W, Decker G, De Leyn P, Van Raemdonck D, Ectors N. Three-field lymphadenectomy for carcinoma of the esophagus and gastroesophageal junction in 174 R0 resections: impact on staging, disease-free survival, and outcome: a plea for adaptation of TNM classification in upper-half esophageal carcinoma. Ann Surg. 2004 Dec;240(6):962-72; discussion 972-4. doi: 10.1097/01.sla.0000145925.70409.d7.
PubMed 15570202Taniyama Y, Nakamura T, Mitamura A, Teshima J, Katsura K, Abe S, Nakano T, Kamei T, Miyata G, Ouchi N. A strategy for supraclavicular lymph node dissection using recurrent laryngeal nerve lymph node status in thoracic esophageal squamous cell carcinoma. Ann Thorac Surg. 2013 Jun;95(6):1930-7. doi: 10.1016/j.athoracsur.2013.03.069. Epub 2013 May 1.
PubMed 23642437Wang X, Hu Y, Wu X, Liang M, Hu Z, Gan X, Li D, Cao Q, Shan H. Near-infrared fluorescence imaging-guided lymphatic mapping in thoracic esophageal cancer surgery. Surg Endosc. 2022 Jun;36(6):3994-4003. doi: 10.1007/s00464-021-08720-7. Epub 2021 Sep 7.
PubMed 34494149
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Navigation Using Near-infrared Imaging in Radical Esophagectomy Surgery ：a Single-arm Clinical Trial
- ClinicalTrials.gov ID
- NCT04173676
- Acronym / sponsor ID
- No.ZDWY[2018]LunziNo.(K31-1)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-sen University
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 22 Nov 2019 (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.
The esophageal squamous cell carcinoma (ESCC) has high prevalence and mortality in China, which become a severe challenge for public health. Esophagectomy is the preferred choice for the patients who are diagnosed with ESCC in early stage .Although three-field lymphadenectomy has improved patient survival and reduced tumor recurrence, Surgery-related complications increased dramatically.
It has become a research hotspot to find an effective detection method to identify the lymph node metastasis of ESCC and avoid ineffective expanded lymphadenectomy .The molecular imaging technology has been developed for intra-operative visualization and precise resection of the tumors.
Indocyanine Green for Injection (ICG) has been used as a contrast agent in the near-infrared imaging system for the surgical navigation technology, which has a relatively positive effect in the clinical application of gastric cancer and liver cancer.There are few reports on the application of ICG near-infrared imaging tracer lymph nodes in the surgery of ESCC. This study intends to identify the detection rate of sentinel lymph node (SLN) and determine the accuracy of regional lymph node metastasis in ESCC by ICG near-infrared imaging technique, which provides clinical evidence for subsequent precise resection of the lymph nodes.
This will be one-arm prospective trial. The ESCC patients will be recruited with strict criteria. 84 patients will be enrolled between18 and 75 years old, without gender limit. The submucosal injection of ICG will be performed preoperatively by gastroscopy on the superior and inferior edge of the esophageal tumor. NIR fluorescence imaging will be performed intraoperatively to observe the lymph nodes. The luminescent lymph node is defined as SLN. According to the standard procedure, 3 field lymphadenectomy will be performed, and all the resected lymph nodes will be subjected to pathological analysis including correlation study of fluorescence signal and tumor tissue in pathology slice.
This clinical trial is anticipated to evaluate the detection rate of SLN in ESCC with ICG near-infrared fluorescence imaging and determine the accuracy of regional lymph node metastasis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The sentinel lymph nodes are observed by submucosal injection of ICG
| Arm | Type | Receives |
|---|---|---|
| use of indocyanine green | Experimental | Drug: Indocyanine Green for Injectionsubmucosal injection of ICG is by gastroscopy on the superior and inferior edge of the esophageal tumor,Dose of 0.5mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years old ≤ age ≤ 75 years old, gender is not limited;
- patient who is diagnosed with ESCC and choose to proceed with surgery
- patient with cTNM stage:T1-3N0-1M0
- tumor located at the middle thoracic or lower thoracic esophagus
- The main organ function is basically normal: Karnofsky score >70%;
Key exclusion criteria (5 listed)
- pregnancy or breastfeeding
- history of iodide or seafood allergy,
- Patient with occult metastatic disease at the time of surgery
- patient with mental disorder;
- Patient who is simultaneously involved in another clinical trial;
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 Green for InjectionThe sentinel lymph nodes were observed by submucosal injection of ICG | Drug | use of indocyanine green |
Primary outcome
the detection rate of sentinel lymph node
Time frame: through study completion, an average of 1 year
the detection rate of sentinel lymph node in all the enrolled patients
The positive rate of sentinel lymph node
Time frame: through study completion, an average of 1 year
the positive rate of sentinel lymph node in all the enrolled patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Results publication: PubMed 31699083Shirakawa S, Toyama H, Kido M, Fukumoto T. A prospective single-center protocol for using near-infrared fluorescence imaging with indocyanine green during staging laparoscopy to detect small metastasis from pancreatic cancer. BMC Surg. 2019 Nov 7;19(1):165. doi: 10.1186/s12893-019-0635-0.
- Results publication: PubMed 31680180Lim HJ, Chiow AKH, Lee LS, Tan SS, Goh BK, Koh YX, Chan CY, Lee SY. Novel method of intraoperative liver tumour localisation with indocyanine green and near-infrared imaging. Singapore Med J. 2021 Apr;62(4):182-189. doi: 10.11622/smedj.2019137. Epub 2019 Nov 4.
- Results publication: PubMed 31575415Yanagi Y, Yoshimaru K, Matsuura T, Shibui Y, Kohashi K, Takahashi Y, Obata S, Sozaki R, Izaki T, Taguchi T. The outcome of real-time evaluation of biliary flow using near-infrared fluorescence cholangiography with Indocyanine green in biliary atresia surgery. J Pediatr Surg. 2019 Dec;54(12):2574-2578. doi: 10.1016/j.jpedsurg.2019.08.029. Epub 2019 Sep 2.
- Results publication: PubMed 31535238Hayami S, Matsuda K, Iwamoto H, Ueno M, Kawai M, Hirono S, Okada K, Miyazawa M, Tamura K, Mitani Y, Kitahata Y, Mizumoto Y, Yamaue H. Visualization and quantification of anastomotic perfusion in colorectal surgery using near-infrared fluorescence. Tech Coloproctol. 2019 Oct;23(10):973-980. doi: 10.1007/s10151-019-02089-5. Epub 2019 Sep 18.
- Results publication: PubMed 31496628Zhou SC, Tian YT, Wang XW, Zhao CD, Ma S, Jiang J, Li EN, Zhou HT, Liu Q, Liang JW, Zhou ZX, Wang XS. Application of indocyanine green-enhanced near-infrared fluorescence-guided imaging in laparoscopic lateral pelvic lymph node dissection for middle-low rectal cancer. World J Gastroenterol. 2019 Aug 21;25(31):4502-4511. doi: 10.3748/wjg.v25.i31.4502.
- Results publication: PubMed 31434361Yamada Y, Ohno M, Fujino A, Kanamori Y, Irie R, Yoshioka T, Miyazaki O, Uchida H, Fukuda A, Sakamoto S, Kasahara M, Matsumoto K, Fuchimoto Y, Hoshino K, Kuroda T, Hishiki T. Fluorescence-Guided Surgery for Hepatoblastoma with Indocyanine Green. Cancers (Basel). 2019 Aug 20;11(8):1215. doi: 10.3390/cancers11081215.
- Results publication: PubMed 31288365Predina JD, Newton AD, Corbett C, Shin M, Sulfyok LF, Okusanya OT, Delikatny EJ, Nie S, Gaughan C, Jarrar D, Pechet T, Kucharczuk JC, Singhal S. Near-infrared intraoperative imaging for minimally invasive pulmonary metastasectomy for sarcomas. J Thorac Cardiovasc Surg. 2019 May;157(5):2061-2069. doi: 10.1016/j.jtcvs.2018.10.169. Epub 2018 Dec 14.
- Results publication: PubMed 23374478Pennathur A, Gibson MK, Jobe BA, Luketich JD. Oesophageal carcinoma. Lancet. 2013 Feb 2;381(9864):400-12. doi: 10.1016/S0140-6736(12)60643-6.
- Results publication: PubMed 27731549Rice TW, Apperson-Hansen C, DiPaola LM, Semple ME, Lerut TE, Orringer MB, Chen LQ, Hofstetter WL, Smithers BM, Rusch VW, Wijnhoven BP, Chen KN, Davies AR, D'Journo XB, Kesler KA, Luketich JD, Ferguson MK, Rasanen JV, van Hillegersberg R, Fang W, Durand L, Allum WH, Cecconello I, Cerfolio RJ, Pera M, Griffin SM, Burger R, Liu JF, Allen MS, Law S, Watson TJ, Darling GE, Scott WJ, Duranceau A, Denlinger CE, Schipper PH, Ishwaran H, Blackstone EH. Worldwide Esophageal Cancer Collaboration: clinical staging data. Dis Esophagus. 2016 Oct;29(7):707-714. doi: 10.1111/dote.12493.
- Results publication: PubMed 15570202Lerut T, Nafteux P, Moons J, Coosemans W, Decker G, De Leyn P, Van Raemdonck D, Ectors N. Three-field lymphadenectomy for carcinoma of the esophagus and gastroesophageal junction in 174 R0 resections: impact on staging, disease-free survival, and outcome: a plea for adaptation of TNM classification in upper-half esophageal carcinoma. Ann Surg. 2004 Dec;240(6):962-72; discussion 972-4. doi: 10.1097/01.sla.0000145925.70409.d7.
- Results publication: PubMed 23642437Taniyama Y, Nakamura T, Mitamura A, Teshima J, Katsura K, Abe S, Nakano T, Kamei T, Miyata G, Ouchi N. A strategy for supraclavicular lymph node dissection using recurrent laryngeal nerve lymph node status in thoracic esophageal squamous cell carcinoma. Ann Thorac Surg. 2013 Jun;95(6):1930-7. doi: 10.1016/j.athoracsur.2013.03.069. Epub 2013 May 1.
- Derived from this study: PubMed 34494149Wang X, Hu Y, Wu X, Liang M, Hu Z, Gan X, Li D, Cao Q, Shan H. Near-infrared fluorescence imaging-guided lymphatic mapping in thoracic esophageal cancer surgery. Surg Endosc. 2022 Jun;36(6):3994-4003. doi: 10.1007/s00464-021-08720-7. Epub 2021 Sep 7.
- Individual participant dataSharing planned: No
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.
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 for Injection in people with Detection Rate of SLN ; Accuracy Rate of Lymph Node Metastasis, run by Fifth Affiliated Hospital, Sun Yat-Sen 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 6 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 24 Feb 2021. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong Shan, PhD (+86-18826913336, shanhong@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the detection rate of sentinel lymph node (time frame: through study completion, an average of 1 year). The study lists 2 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 NCT04173676, which also lists 12 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 24 Feb 2021.