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Clinical study of intraoperative pulmonary sentinel lymph nodes mapping using Vitamin B2 for lung cancer surgery

Clinical study of intraoperative pulmonary sentinel lymph nodes mapping using Vitamin B2 for lung cancer surgery - Sentinel lymph nodes mapping using Vitamin B2

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000025816
Enrollment
10
Registered
2017-01-26
Start date
2017-02-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer

Interventions

1) Vitamin B2, a fluorescent substance 2) Fluorescence endoscopy

Sponsors

Kanazawa University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Cases where a definitive diagnosis of non small cell pulmonary carcinoma has been obtained prior to surgery. Cases which belong to a clinical stage of 1A to 3B, where complete resection is expected to be carried out. Cases with no previous history of other malignant tumors. Cases with no previous history of treatment for lung cancer, such as radiation or chemotherapy, prior to surgery. Cases not accompanied by inflammatory conditions, such as pneumonia and pleurisy. Cases involving patients between the ages of 20 and 75 years with an ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 1. Cases with no history of bronchial asthma or serious drug allergy. Cases with normal bone marrow, liver and kidney function. Cases with no serious complication involving respiratory or cardiac function and that can withstand surgery. Cases where written consent has been obtained from the patient with regard to participating in the trial.

Exclusion criteria

Exclusion criteria: Cases with cardiovascular disease that requires treatment, interstitial pneumonia, severe pulmonary emphysema, or impaired liver or kidney function. Cases where it is impossible to perform lung lobe resection and systemic lymph node dissection due to problems with respiratory function or for other reasons. Cases involving pregnant or lactating women. Cases where the lead physician has determined that there is a problem with regard to performing surgery. Cases where the administration of vitamin B2 has been known to cause some abnormality.

Design outcomes

Primary

MeasureTime frame
Safety: Onset of an adverse event

Secondary

MeasureTime frame
1) Possibility to identify sentinel lymph node 2) Sensitibity, specificity, positive predictive value, negative predictive value to identify sentinel lymph node

Countries

Japan

Contacts

Public ContactMasaya Tamura

Kanazawa University School of Medicine Department of General Thoracic surgery

mtamura@med.kanazawa-u.ac.jp+81-076-265-2000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026