Early Gastric CancerPhase 2NCT04973475
Indocyanine Green Tracer Using in Laparoscopic Distal Gastrectomy for Early Gastric Cancer
A Phase 2 study testing Indocyanine Green in people with Early Gastric Cancer and Indocyanine Green, run by Fujian Medical University at 1 site in China.
Trial summary
This study aims to explore the value of indocyanine green (ICG) in laparoscopic distal gastrectomy with lymph node dissection for early gastric cancer.The patients with early gastric adenocarcinoma (cT1, N-/+, M0) will be studied. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Early Gastric Cancer, Indocyanine Green, Lymph Node Dissection
- What is being tested?
- Indocyanine Green
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Jul 2021to Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- Clinical stage tumor T1 (cT1), N0/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition. Preoperative staging was made by conducting mandatory computed tomography (CT) scans and an optional endoscopic ultrasound
- No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
- Tumor located in the lower third of the stomach, expected to receive radical distal gastrectomy
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
- American Society of Anesthesiology score (ASA) class I, II, or III
- Written informed consent
Who cannot join
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
- Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
- History of other malignant disease within past five years
Show all 17Show fewer
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within past six months
- History of cerebrovascular accident within past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- Forced expiratory volume in 1 second (FEV1)<50% of predicted values
- Rejection of laparoscopic resection
- Preoperatively confirmed tumors invading the dentate line or duodenum
- History of allergy to iodine agents
- Tumor located in the upper third of the stomach, expected to receive radical total gastrectomy
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastric Surgery
Fuzhou, Fujian
Chang-Ming Huang, Huang, Huang, hcmlr2002@163.com
About this study
Official title: Prospective Clinical Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Distal Gastrectomy With Lymph Node Dissection for Early Gastric Cancer
This study aims to explore the value of indocyanine green (ICG) in laparoscopic distal gastrectomy with lymph node dissection for early gastric cancer.The patients with early gastric adenocarcinoma (cT1, N-/+, M0) will be studied.
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will receiving injection of indocyanine greenat 8 points around the primary tumor with gastroscope 1 day before surgery. During the operation, laparoscopic gastrectomy and perigastric lymph node dissection were performed under ICG imaging equipment. After the surgical specimens were isolated, under the fluorescent illumination of the ICG imaging equipment, the lymph nodes that showed fluorescence and the lymph nodes that did not show fluorescence were collected from each LN station.
- Being tested
- Indocyanine Green
- Keywords
- Stomach Neoplasms, Indocyanine Green Tracer, Laparoscopic Distal Gastrectomy, Lymph Node Dissection
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine GreenDrug
Also called ICG
Laparoscopic distal gastrectomy with lymph node dissection for early gastric cancer using Indocyanine Green Tracer
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Indocyanine Green Tracer | Experimental | Indocyanine Green Tracer will be used in laparoscopic distal gastrectomy with lymph node dissection for gastric adenocarcinoma. Receives: Drug: Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
False negative rate
The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes
Measured: One month after surgery
Secondary outcomes (20)
True positive rate
The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes
Measured: One month after surgery
False positive rate
The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes
Measured: One month after surgery
True negative rate
The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes
Measured: One month after surgery
Total number of retrieved lymph nodes
Total number of retrieved lymph nodes
Measured: One month after surgery
Lymph node noncompliance rate
Lymph node noncompliance was defined as the absence of lymph nodes that should have been excised from more than 1 lymph node station. Major lymph node noncompliance was defined as more than 2 intended lymph node stations that were not removed.
Measured: One month after surgery
Number of Metastasis Lymph Nodes
Number of Metastasis Lymph Nodes
Measured: One month after surgery
Metastasis rate of lymph node
Metastasis rate of lymph node
Measured: One month after surgery
Morbidity and mortality rates
This is for the early postoperative complication and mortality, which defined as the event observed within 30 days after surgery.
Measured: One month after surgery
3-year overall survival rate
3-year overall survival rate
Measured: 36 months
3-year disease free survival rate
3-year disease free survival rate
Measured: 36 months
3-year recurrence pattern
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
Measured: 36 months
Intraoperative morbidity rates
The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
Measured: 1 day
Time to first ambulation
Time to first ambulation in hours is used to assess the postoperative recovery course.
Measured: 30 days
Time to first flatus
Time to first flatus in days is used to assess the postoperative recovery course.
Measured: 30 days
Time to first liquid diet
Time to first liquid diet in days is used to assess the postoperative recovery course.
Measured: 30 days
Time to first soft diet
Time to first soft diet in days is used to assess the postoperative recovery course.
Measured: 30 days
Duration of postoperative hospital stay
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Measured: 30 days
The variation of white blood cell count
The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Measured: Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of hemoglobin
The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Measured: Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of C-reactive protein
The variation of C-reactive protein
Measured: Preoperative 3 days and postoperative 1, 3, and 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study startJul 2021 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Early Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Ming Huang, Prof., Fujian Medical University
- Investigators
- Chang-Ming Huang, MD, Study chair, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973475
- Sponsor's protocol ID
- FUGES-023
- Status last verified
- Jul 2021
- First submitted
- 13 Jul 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fock KM. Review article: the epidemiology and prevention of gastric cancer. Aliment Pharmacol Ther. 2014 Aug;40(3):250-60. doi: 10.1111/apt.12814. Epub 2014 Jun 10.
PubMed 24912650Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Msika S, Chastang C, Houry S, Lacaine F, Huguier M. Lymph node involvement as the only prognostic factor in curative resected gastric carcinoma: a multivariate analysis. World J Surg. 1989 Jan-Feb;13(1):118-23; discussion 123. doi: 10.1007/BF01671171.
PubMed 2471364Maruyama K, Gunven P, Okabayashi K, Sasako M, Kinoshita T. Lymph node metastases of gastric cancer. General pattern in 1931 patients. Ann Surg. 1989 Nov;210(5):596-602. doi: 10.1097/00000658-198911000-00005.
PubMed 2818028Zhang YX, Yang K. Significance of nodal dissection and nodal positivity in gastric cancer. Transl Gastroenterol Hepatol. 2020 Apr 5;5:17. doi: 10.21037/tgh.2019.09.13. eCollection 2020.
PubMed 32258521Mocellin S. The Effect of Lymph Node Dissection on the Survival of Patients With Operable Gastric Carcinoma. JAMA Oncol. 2016 Oct 1;2(10):1363-1364. doi: 10.1001/jamaoncol.2016.2044.
PubMed 27442439Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2018 (5th edition). Gastric Cancer. 2021 Jan;24(1):1-21. doi: 10.1007/s10120-020-01042-y. Epub 2020 Feb 14. No abstract available.
PubMed 32060757Sasako M, McCulloch P, Kinoshita T, Maruyama K. New method to evaluate the therapeutic value of lymph node dissection for gastric cancer. Br J Surg. 1995 Mar;82(3):346-51. doi: 10.1002/bjs.1800820321.
PubMed 7796005Kurokawa Y, Takeuchi H, Doki Y, Mine S, Terashima M, Yasuda T, Yoshida K, Daiko H, Sakuramoto S, Yoshikawa T, Kunisaki C, Seto Y, Tamura S, Shimokawa T, Sano T, Kitagawa Y. Mapping of Lymph Node Metastasis From Esophagogastric Junction Tumors: A Prospective Nationwide Multicenter Study. Ann Surg. 2021 Jul 1;274(1):120-127. doi: 10.1097/SLA.0000000000003499.
PubMed 31404008Baiocchi GL, Giacopuzzi S, Reim D, Piessen G, Costa PMD, Reynolds JV, Meyer HJ, Morgagni P, Gockel I, Santos LL, Jensen LS, Murphy T, D'Ugo D, Rosati R, Fumagalli Romario U, Degiuli M, Kielan W, Monig S, Kolodziejczyk P, Polkowski W, Pera M, Schneider PM, Wijnhoven B, de Steur WO, Gisbertz SS, Hartgrink H, van Sandick JW, Botticini M, Holscher AH, Allum W, De Manzoni G. Incidence and Grading of Complications After Gastrectomy for Cancer Using the GASTRODATA Registry: A European Retrospective Observational Study. Ann Surg. 2020 Nov;272(5):807-813. doi: 10.1097/SLA.0000000000004341.
PubMed 32925254Han SU, Hur H, Lee HJ, Cho GS, Kim MC, Park YK, Kim W, Hyung WJ; Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) Group. Surgeon Quality Control and Standardization of D2 Lymphadenectomy for Gastric Cancer: A Prospective Multicenter Observational Study (KLASS-02-QC). Ann Surg. 2021 Feb 1;273(2):315-324. doi: 10.1097/SLA.0000000000003883.
PubMed 33064386Liu M, Xing J, Xu K, Yuan P, Cui M, Zhang C, Yang H, Yao Z, Zhang N, Tan F, Su X. Application of Near-Infrared Fluorescence Imaging with Indocyanine Green in Totally Laparoscopic Distal Gastrectomy. J Gastric Cancer. 2020 Sep;20(3):290-299. doi: 10.5230/jgc.2020.20.e25. Epub 2020 Aug 31.
PubMed 33024585Roh CK, Choi S, Seo WJ, Cho M, Son T, Kim HI, Hyung WJ. Indocyanine green fluorescence lymphography during gastrectomy after initial endoscopic submucosal dissection for early gastric cancer. Br J Surg. 2020 May;107(6):712-719. doi: 10.1002/bjs.11438. Epub 2020 Feb 7.
PubMed 32031248Cianchi F, Indennitate G, Paoli B, Ortolani M, Lami G, Manetti N, Tarantino O, Messeri S, Foppa C, Badii B, Novelli L, Skalamera I, Nelli T, Coratti F, Perigli G, Staderini F. The Clinical Value of Fluorescent Lymphography with Indocyanine Green During Robotic Surgery for Gastric Cancer: a Matched Cohort Study. J Gastrointest Surg. 2020 Oct;24(10):2197-2203. doi: 10.1007/s11605-019-04382-y. Epub 2019 Sep 4.
PubMed 31485904
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Distal Gastrectomy With Lymph Node Dissection for Early Gastric Cancer
- ClinicalTrials.gov ID
- NCT04973475
- Acronym / sponsor ID
- FUGES-023
- Keywords
- Stomach Neoplasms, Indocyanine Green Tracer, Laparoscopic Distal Gastrectomy, Lymph Node Dissection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 22 Jul 2021 (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 study aims to explore the value of indocyanine green (ICG) in laparoscopic distal gastrectomy with lymph node dissection for early gastric cancer.The patients with early gastric adenocarcinoma (cT1, N-/+, M0) will be studied.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will receiving injection of indocyanine greenat 8 points around the primary tumor with gastroscope 1 day before surgery. During the operation, laparoscopic gastrectomy and perigastric lymph node dissection were performed under ICG imaging equipment. After the surgical specimens were isolated, under the fluorescent illumination of the ICG imaging equipment, the lymph nodes that showed fluorescence and the lymph nodes that did not show fluorescence were collected from each LN station.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Indocyanine Green Tracer | Experimental | Drug: Indocyanine GreenIndocyanine Green Tracer will be used in laparoscopic distal gastrectomy with lymph node dissection for gastric adenocarcinoma. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age from 18 to 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- Clinical stage tumor T1 (cT1), N0/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition. Preoperative staging was made by conducting mandatory computed tomography (CT) scans and an optional endoscopic ultrasound
- No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
- Tumor located in the lower third of the stomach, expected to receive radical distal gastrectomy
Key exclusion criteria (17 listed)
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
- Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
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: ICGLaparoscopic distal gastrectomy with lymph node dissection for early gastric cancer using Indocyanine Green Tracer | Drug | Experimental: Indocyanine Green Tracer |
Primary outcome
False negative rate
Time frame: One month after surgery
The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes
20 secondary outcomes
True positive rate
Time frame: One month after surgery
False positive rate
Time frame: One month after surgery
True negative rate
Time frame: One month after surgery
Total number of retrieved lymph nodes
Time frame: One month after surgery
Lymph node noncompliance rate
Time frame: One month after surgery
Number of Metastasis Lymph Nodes
Time frame: One month after surgery
Metastasis rate of lymph node
Time frame: One month after surgery
Morbidity and mortality rates
Time frame: One month after surgery
3-year overall survival rate
Time frame: 36 months
3-year disease free survival rate
Time frame: 36 months
3-year recurrence pattern
Time frame: 36 months
Intraoperative morbidity rates
Time frame: 1 day
Time to first ambulation
Time frame: 30 days
Time to first flatus
Time frame: 30 days
Time to first liquid diet
Time frame: 30 days
Time to first soft diet
Time frame: 30 days
Duration of postoperative hospital stay
Time frame: 30 days
The variation of white blood cell count
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of hemoglobin
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of C-reactive protein
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Background: PubMed 24912650Fock KM. Review article: the epidemiology and prevention of gastric cancer. Aliment Pharmacol Ther. 2014 Aug;40(3):250-60. doi: 10.1111/apt.12814. Epub 2014 Jun 10.
- Background: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background: PubMed 2471364Msika S, Chastang C, Houry S, Lacaine F, Huguier M. Lymph node involvement as the only prognostic factor in curative resected gastric carcinoma: a multivariate analysis. World J Surg. 1989 Jan-Feb;13(1):118-23; discussion 123. doi: 10.1007/BF01671171.
- Background: PubMed 2818028Maruyama K, Gunven P, Okabayashi K, Sasako M, Kinoshita T. Lymph node metastases of gastric cancer. General pattern in 1931 patients. Ann Surg. 1989 Nov;210(5):596-602. doi: 10.1097/00000658-198911000-00005.
- Background: PubMed 32258521Zhang YX, Yang K. Significance of nodal dissection and nodal positivity in gastric cancer. Transl Gastroenterol Hepatol. 2020 Apr 5;5:17. doi: 10.21037/tgh.2019.09.13. eCollection 2020.
- Background: PubMed 27442439Mocellin S. The Effect of Lymph Node Dissection on the Survival of Patients With Operable Gastric Carcinoma. JAMA Oncol. 2016 Oct 1;2(10):1363-1364. doi: 10.1001/jamaoncol.2016.2044.
- Background: PubMed 32060757Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2018 (5th edition). Gastric Cancer. 2021 Jan;24(1):1-21. doi: 10.1007/s10120-020-01042-y. Epub 2020 Feb 14. No abstract available.
- Background: PubMed 7796005Sasako M, McCulloch P, Kinoshita T, Maruyama K. New method to evaluate the therapeutic value of lymph node dissection for gastric cancer. Br J Surg. 1995 Mar;82(3):346-51. doi: 10.1002/bjs.1800820321.
- Background: PubMed 31404008Kurokawa Y, Takeuchi H, Doki Y, Mine S, Terashima M, Yasuda T, Yoshida K, Daiko H, Sakuramoto S, Yoshikawa T, Kunisaki C, Seto Y, Tamura S, Shimokawa T, Sano T, Kitagawa Y. Mapping of Lymph Node Metastasis From Esophagogastric Junction Tumors: A Prospective Nationwide Multicenter Study. Ann Surg. 2021 Jul 1;274(1):120-127. doi: 10.1097/SLA.0000000000003499.
- Background: PubMed 32925254Baiocchi GL, Giacopuzzi S, Reim D, Piessen G, Costa PMD, Reynolds JV, Meyer HJ, Morgagni P, Gockel I, Santos LL, Jensen LS, Murphy T, D'Ugo D, Rosati R, Fumagalli Romario U, Degiuli M, Kielan W, Monig S, Kolodziejczyk P, Polkowski W, Pera M, Schneider PM, Wijnhoven B, de Steur WO, Gisbertz SS, Hartgrink H, van Sandick JW, Botticini M, Holscher AH, Allum W, De Manzoni G. Incidence and Grading of Complications After Gastrectomy for Cancer Using the GASTRODATA Registry: A European Retrospective Observational Study. Ann Surg. 2020 Nov;272(5):807-813. doi: 10.1097/SLA.0000000000004341.
- Background: PubMed 33064386Han SU, Hur H, Lee HJ, Cho GS, Kim MC, Park YK, Kim W, Hyung WJ; Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) Group. Surgeon Quality Control and Standardization of D2 Lymphadenectomy for Gastric Cancer: A Prospective Multicenter Observational Study (KLASS-02-QC). Ann Surg. 2021 Feb 1;273(2):315-324. doi: 10.1097/SLA.0000000000003883.
- Background: PubMed 33024585Liu M, Xing J, Xu K, Yuan P, Cui M, Zhang C, Yang H, Yao Z, Zhang N, Tan F, Su X. Application of Near-Infrared Fluorescence Imaging with Indocyanine Green in Totally Laparoscopic Distal Gastrectomy. J Gastric Cancer. 2020 Sep;20(3):290-299. doi: 10.5230/jgc.2020.20.e25. Epub 2020 Aug 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang-Ming Huang, MD study chair
Fujian Medical University Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Indocyanine Green in people with Early Gastric Cancer and Indocyanine Green, run by Fujian 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 8 inclusion and 17 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 22 Jul 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chang-Ming Huang, MD (+86-13805069676, hcmlr2002@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
False negative rate (time frame: One month after surgery). 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 NCT04973475, which also lists 14 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 22 Jul 2021.