Application of SERS Technology Based Intraoperative Navigation System in Lung Cancer

Lung Cancer Clinical Trial

Official title:

Application of Surface-enhanced Raman Scatting (SERS) Technology Based Intraoperative Navigation System in Lung Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05881057
• Other study ID #: 2022HY0519
• Status: Not yet recruiting
• Start date: June 2023
• Est. completion date: June 2028

Study information

• Verified date: May 2023
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Yayi He, PHD,MD
• Phone: +86 021-65115006
• Email: doctorjael[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to explore the application of Surface-enhanced Raman Scatting (SERS) technology in lung cancer surgery and clarify its mechanism through multi-omics mass spectrometry platform, and then further prove the clinical transformation value of this technology.

Description:

This study intends to apply the intraoperative navigation system based on Surface-enhanced Raman Scatting (SERS) technology to detect the PH of lung tissue, and to evaluate the benign and malignant resection margins of lung tissue based on this. In order to clarify the discrimination mechanism, a multi-omics mass spectrometry platform is planned to study the internal small molecules and pathway changes. In addition, the patients were followed up for five years to explore the correlation between the prognosis of patients and the PH of lung tissues and lymph nodes, which could prove the clinical transformation value of this technology.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 2028
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Voluntary participation in clinical research; Fully understand and informed the study and sign the informed consent form (ICF); Be willing to follow and be able to complete all trial procedures.

2. Male or female aged 18-75 years or more when signing ICF.

3. Extended tumor resection was performed to remove the lung tumor tissue, and the resection margin was =2cm from the tumor margin.

4. The effective measured diameter of all the lung tissues to be measured was greater than 0.5cm.

5. The patient had not received previous systemic therapy for cancer.

Exclusion Criteria:

1. Unresectable lung cancer patients.

2. Patients had received previous systemic therapy for lung cancer.

3. Patients with other active malignant tumors within the past year or at the same time.

4. The patient had a known history of psychotropic drug abuse or drug use; She had a history of alcohol abuse.

5. According to the investigator's judgment, the patient had other factors that may lead to the early termination of the study.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

References & Publications (6)

Becker N, Motsch E, Trotter A, Heussel CP, Dienemann H, Schnabel PA, Kauczor HU, Maldonado SG, Miller AB, Kaaks R, Delorme S. Lung cancer mortality reduction by LDCT screening-Results from the randomized German LUSI trial. Int J Cancer. 2020 Mar 15;146(6) — View Citation

Edwards JG, Chansky K, Van Schil P, Nicholson AG, Boubia S, Brambilla E, Donington J, Galateau-Salle F, Hoffmann H, Infante M, Marino M, Marom EM, Nakajima J, Ostrowski M, Travis WD, Tsao MS, Yatabe Y, Giroux DJ, Shemanski L, Crowley J, Krasnik M, Asamura — View Citation

National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4; — View Citation

Pastorino U, Silva M, Sestini S, Sabia F, Boeri M, Cantarutti A, Sverzellati N, Sozzi G, Corrao G, Marchiano A. Prolonged lung cancer screening reduced 10-year mortality in the MILD trial: new confirmation of lung cancer screening efficacy. Ann Oncol. 201 — View Citation

Saji H, Okada M, Tsuboi M, Nakajima R, Suzuki K, Aokage K, Aoki T, Okami J, Yoshino I, Ito H, Okumura N, Yamaguchi M, Ikeda N, Wakabayashi M, Nakamura K, Fukuda H, Nakamura S, Mitsudomi T, Watanabe SI, Asamura H; West Japan Oncology Group and Japan Clinic — View Citation

Suzuki K, Watanabe SI, Wakabayashi M, Saji H, Aokage K, Moriya Y, Yoshino I, Tsuboi M, Nakamura S, Nakamura K, Mitsudomi T, Asamura H; West Japan Oncology Group and Japan Clinical Oncology Group. A single-arm study of sublobar resection for ground-glass o — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival(OS)	Time from randomization to death (from any cause).	From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months
Primary	Recurrence free survival(RFS)	The time from surgery to recurrence or the end of follow-up was defined.	From date of randomization until the date of first documented progression from any cause, whichever came first, assessed up to 60 months