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Novel Light Delivery Methods for Lung Cancer Photodynamic Therapy - A Pilot Study

NCT04753918 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2021-02-15

No results posted yet for this study

Summary

This research study is being conducted to assess the safety and feasibility of using a newly developed bronchoscopic light delivery method of photodynamic therapy to treat subjects with solid tumors in peripheral lung, who are inoperable or refused surgery.

Conditions

  • Non-small Cell Lung Cancer (NSCLC)
  • Lung Metastasis

Interventions

DRUG

Porfimer sodium

Photofrin 2mg/kg was iv injected 48-50 hours before light illumination.

DRUG

Ethiodized oil

In hybrid operation room setting, a navigational bronchoscope guide sheath was inserted to the proximal end of the tumor region. About 5 ml Lipiodol was infused to full cover whole the tumor.

PROCEDURE

Novel light delivery methods of photodynamic therapy

Using high-refraction index contrast medium: lipiodol as a light diffusor to enhance the range of photodynamic therapy

DEVICE

Fiber optic

A cylindrical laser fiber was then inserted through the guide sheath to the tumor region then illuminate light to complete the photodynamic therapy.

Sponsors & Collaborators

  • Taoyuan General Hospital

    lead OTHER_GOV

Principal Investigators

  • Yei-San Hsieh, MD · Taoyan General Hospital, Ministry of Health and Welfare

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2021-09-30
Completion
2022-02-28
FDA Drug
Yes
FDA Device
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04753918 on ClinicalTrials.gov