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To test the feasibility of super-D ENB guided-PDT to treat small lung cancer which cannot be eradicated through surgical resection.

PDT with super-D EBN localization will be given for treating the target lung lesion. Intrvenous photofrin (2mg/kg) will be given 48 hours before intervention. After localization of the tumor by ENB, a 630nm of light will be give for the lesion with the dosage of 2oo J/cm. Intravenous general anesthesia and endobronchial intubation will be performed under the whole procedure.

super-D ENB guided-PDT

Jang-Ming Lee, MD. PhD.

Peiwen Yang, PhD.

Jang-Ming Lee

With the increased incidence of lung cancer and prevalence of low dose CT screening, treating of early lung cancer has becoming an important issue in the clinical practice of thoracic oncology. In this clinical study, the investigators will evaluate whether superDimension (superD) ENB (Electromagnetic navigation bronchoscopy) in combination with interstitial photodynamic therapy can provide the chance of tumor eradication.

Lung cancer is the one the major cause of cancer death all over the world especially in Asia. The prevalence of low dose CT screening has made more patients of lung cancer treated in the early stage. The treatment of choice for of early lung cancer is surgical resection. However, several difficulties exist in surgery for treating early lung cancer. eg. Some presenting as multi-focal lesions, which cannot be completely eradicated by surgical resection.

Electromagnetic navigation bronchoscopy (ENB)（superDimension™ Navigation System, super-D ENB) is a novel technique, which uses an image guided localization system to direct steerable bronchoscopic tools to predetermined points within the bronchial tree. This technology allows improved access to peripheral lesions in particular.

Photodynamic therapy (PDT) has been adopted an effective treatment option for the central located lung cancer by using photosensitizer which is focally retained in the tumor leading to tumor-specific abrasion by irradiating with a certain wave-length of light. The most frequently used and commercially available photosensitizer for lung cancer is PDT with Photofrin under 623 nm red light irradiation. For the peripheral lung cancer which cannot be approached by bronchoscopy, interstitial PDT with the aids of CT guided catheter implantation has been adopted. However, there are potential disadvantages of such approach including 1) bleeding or hemothorax during CT-guided catheter implantation; 2) dislodging of the catheter after lung collapse in the procedure; 3) unable to treat other lesion after pneumothorax.

In the current proposal, the investigators use ENB in combination with PDT to handle to test the feasibility of super-D ENB guided-PDT to treat small lung cancer which cannot be eradicated through surgical resection.

ENB and Photodynamic Therapy in the Treatment for Early Lung Cancer

The Application of Electro-magnetic Navigation Bronchoscopy (ENB) and Photodynamic Therapy in the Treatment for Early Lung Cancer

The time interval between enrollment and the earliest onset of any of the following events,: tumor local recurrence , distant metastasis, and mortality

defined as any deviation from the normal postoperative course

the pulmonary function at 6, 12, and 24 months post-operation

The time interval between enrollment and death

National Taiwan University Hospital

The participants enrolled will receive single fraction of ultra-high dose SBRT(30Gy/1F).

SBRT

Hongqing Zhuang, M.D.

Yi Chen, M.D.

The goal of this prospective single-arm phase II study is to study the efficacy and safety of stereotactic body radiotherapy (SBRT) for early lung cancer. The main questions it aims to answer are:

How effective is this regimen of SBRT for early lung cancer? How safe is this regimen of SBRT for early lung cancer?

The goal of this prospective single-arm phase II study is to study the efficacy and safety of stereotactic body radiotherapy (SBRT) for early lung cancer. This study intends to enroll 100 participants in 2 years. The participants enrolled will receive single fraction of ultra-high dose stereotactic body radiotherapy (SBRT) (30Gy/1F).

Single Ultra-high Dose Stereotactic Body Radiation Therapy for Early Lung Cancer

Clinical Study of Single Ultra-high Dose Stereotactic Body Radiation Therapy for Early Lung Cancer

Study Protocol, Statistical Analysis Plan, and Clinical Study Report will be shared with researchers for research use after permission was obtained from the study institution.

The time from the date of treatment to the date of disease progression or death or last follow-up.

The time from the date of treatment to the date of death or last follow-up.

The incidence of All adverse event (AE), treatment emergent AE (TEAE), treatment-related AE (TRAE), immune-related AE (irAE), serious AE (SAE) and radiation-related AE(rAE), the relevance and severity related with the study protocol.

Peking University Third Hospital

After surgical treatment, pathological specimens were extracted to obtain pathological results

Surgery

This experiment has now collected 50 cases, all through CT chest scans and blood exosome detection. Twenty-two patients underwent surgical treatment and 14 tissue specimens were examined for cancer and paracancerous tissue exosomesWe found that exosomal micor-A was highly expressed in early stage lung cancer tissues and was significantly higher than paracancerous tissues. The micor-A in the adjacent tissues was significantly higher than that in peripheral blood exosomes

Combined Diagnosis of CT and Exosome in Early Lung Cancer

exosomal micor-A was highly expressed in early stage lung cancer tissues

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ENB and Photodynamic Therapy in the Treatment for Early Lung Cancer	NCT03211078	Lung Cancer	super-D ENB gui...	20 Years -	National Taiwan University Hospital
Single Ultra-high Dose Stereotactic Body Radiation Therapy for Early Lung Cancer	NCT05802654	Early Lung Canc... Stereotactic Bo...	SBRT	18 Years - 80 Years	Peking University Third Hospital
Combined Diagnosis of CT and Exosome in Early Lung Cancer	NCT03542253	Early Lung Canc...	Surgery	-	Second Affiliated Hospital of Soochow University

Spots Global Cancer Trial Database for early lung cancer