Novel Light Delivery Methods for Lung Cancer Photodynamic Therapy - A Pilot Study
Primary Purpose
Non-small Cell Lung Cancer (NSCLC), Lung Metastasis
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Porfimer sodium
Ethiodized oil
Novel light delivery methods of photodynamic therapy
Fiber optic
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer (NSCLC) focused on measuring Photodynamic Therapy, Peripheral Lung cancer
Eligibility Criteria
Inclusion Criteria:
- Male or female aged between 20 and 75
- Diagnosed with histologically confirmed solid tumor located in the peripheral lung
- Not candidate or failed of standard chemotherapy, radiotherapy or surgery
- Primary lung cancer without mediastinal or distant lymph nodes metastasis (N0-N1)
- The tumor is ≤ 2 cm in size and clearly observable in computerized tomography (CT scan)
- Able to sign an informed consent
Exclusion Criteria:
- Diagnostic of small cell lung cancer or non-solid malignancy
- Solid tumor located in central lung
- Primary lung cancer without distant metastasis (M0)
- Received radiotherapy over the target tumor
- Abnormal blood results
- Received chemotherapy/immunotherapy in the last 4 weeks
- Tumor invasion with major blood vessels
- Allergy to porphyria or known hypersensitivity to Photofrin® or porphyrin-like compounds or to any of its excipients, allergy to Lipiodol or iodine-content contrast medium
- Planned surgical procedure within the next 90 days
- Coexisting ophthalmic disease likely to require slit-lamp examination within the next 90 days
- Acute or chronic medical or psychological illnesses that prevent endoscopy procedures
- Pregnant or intend to become pregnant, breastfeeding or intend to breastfeed during the study
- Received PDT during the past 1 months
- Severe impairment of your kidney or liver function
- Participates or intends to participate in another drug study (other than observational studies) during the study
- Victim of AIDS
- Other critical condition that the investigator considered not suited for participation
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Novel light delivery methods for photodynamic therapy
Arm Description
High refraction-index contrast medium: Lipiodol injected in the bronchial tree can enhance the treatment extension of the photodynamic therapy
Outcomes
Primary Outcome Measures
Feasibility to Perform Novel Photodynamic Therapy Into Tumor
Number of times photodynamic therapy was delivered into the tumor using navigational bronchoscopy for each subject.
Adverse Events Incidence Indicating Safety of Novel Photodynamic Therapy
The incidence of adverse events following Novel PDT will be presented as the primary safety indicator for this treatment.
Secondary Outcome Measures
Tumor Response at 3 Months Post Photodynamic Therapy (PDT)
From the start of treatment until 3 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT)
Up to 6 months
Full Information
NCT ID
NCT04753918
First Posted
February 9, 2021
Last Updated
February 9, 2021
Sponsor
Taoyuan General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04753918
Brief Title
Novel Light Delivery Methods for Lung Cancer Photodynamic Therapy - A Pilot Study
Official Title
Single Center, Prospective, Open Label, Single-arm Clinical Study of Safety & Feasibility of Using Navigational Bronchoscopy to Perform Interstitial PD Therapy Using Lipiodol® as a Light Deliver and Photofrin® as Treatment in Subjects With Unresectable Solid Tumor in Peripheral Lung
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
February 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taoyuan General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
Lung cancer accounts for almost one-third of cancer deaths. Cancer screening strategies have the potential to achieve a 20% reduction in death rates. Newly developed bronchoscopic technologies (such as navigational bronchoscopy in a hybrid operation room) have been shown to enable physicians to safely reach lesions in peripheral regions of the lung and obtain a diagnosis. This new technology may now potentially offer bronchoscopic therapeutic interventions, such as photodynamic therapy, to tumors that were previously unreachable due to their peripheral anatomic location.
Photodynamic therapy (PDT) uses a combination of a photosensitizing drug (a drug that is activated by light), called porfimer sodium (Photofrin®), and a light from a laser that emits no heat. This technique works to allow the medical doctor to specifically target and destroy abnormal or cancer cells while limiting damage to surrounding healthy tissue. The activation of the drug is done by lighting the abnormal area using a fiber-optic device (very fine fiber [like a fishing line] that permits light transmission) inserted into a flexible tube called a bronchoscope. The light activates the porfimer sodium, which is concentrated in the abnormal tissue, leading to its destruction. But the penetrating depth of light is about 1.5 to 2 cm limits the treatment range of tumor size.
We proposed a novel light delivery method of instilling a high-refractive-index (RI) liquid (Lipiodol) to enhance light delivery in the lung.
The purpose of this study is to determine if physicians can reach the tumors in the periphery of the lung via electro-navigational bronchoscopy in a hybrid operation room and inject the lipiodol to cover the whole tumor then deliver photodynamic therapy by placing the optical fiber into the tumor
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer (NSCLC), Lung Metastasis
Keywords
Photodynamic Therapy, Peripheral Lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Novel light delivery methods for photodynamic therapy
Arm Type
Experimental
Arm Description
High refraction-index contrast medium: Lipiodol injected in the bronchial tree can enhance the treatment extension of the photodynamic therapy
Intervention Type
Drug
Intervention Name(s)
Porfimer sodium
Other Intervention Name(s)
Photofrin
Intervention Description
Photofrin 2mg/kg was iv injected 48-50 hours before light illumination.
Intervention Type
Drug
Intervention Name(s)
Ethiodized oil
Other Intervention Name(s)
Lipiodol
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Novel light delivery methods of photodynamic therapy
Intervention Description
Using high-refraction index contrast medium: lipiodol as a light diffusor to enhance the range of photodynamic therapy
Intervention Type
Device
Intervention Name(s)
Fiber optic
Intervention Description
A cylindrical laser fiber was then inserted through the guide sheath to the tumor region then illuminate light to complete the photodynamic therapy.
Primary Outcome Measure Information:
Title
Feasibility to Perform Novel Photodynamic Therapy Into Tumor
Description
Number of times photodynamic therapy was delivered into the tumor using navigational bronchoscopy for each subject.
Time Frame
Day 3 post-treatment
Title
Adverse Events Incidence Indicating Safety of Novel Photodynamic Therapy
Description
The incidence of adverse events following Novel PDT will be presented as the primary safety indicator for this treatment.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Tumor Response at 3 Months Post Photodynamic Therapy (PDT)
Description
From the start of treatment until 3 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Time Frame
Up to 3 months
Title
Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT)
Description
Up to 6 months
Time Frame
From the start of treatment until 6 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female aged between 20 and 75
Diagnosed with histologically confirmed solid tumor located in the peripheral lung
Not candidate or failed of standard chemotherapy, radiotherapy or surgery
Primary lung cancer without mediastinal or distant lymph nodes metastasis (N0-N1)
The tumor is ≤ 2 cm in size and clearly observable in computerized tomography (CT scan)
Able to sign an informed consent
Exclusion Criteria:
Diagnostic of small cell lung cancer or non-solid malignancy
Solid tumor located in central lung
Primary lung cancer without distant metastasis (M0)
Received radiotherapy over the target tumor
Abnormal blood results
Received chemotherapy/immunotherapy in the last 4 weeks
Tumor invasion with major blood vessels
Allergy to porphyria or known hypersensitivity to Photofrin® or porphyrin-like compounds or to any of its excipients, allergy to Lipiodol or iodine-content contrast medium
Planned surgical procedure within the next 90 days
Coexisting ophthalmic disease likely to require slit-lamp examination within the next 90 days
Acute or chronic medical or psychological illnesses that prevent endoscopy procedures
Pregnant or intend to become pregnant, breastfeeding or intend to breastfeed during the study
Received PDT during the past 1 months
Severe impairment of your kidney or liver function
Participates or intends to participate in another drug study (other than observational studies) during the study
Victim of AIDS
Other critical condition that the investigator considered not suited for participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yei-San Hsieh, MD
Phone
886-975061108
Email
yeisanh@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hwailuh Chang, MD
Phone
886-3-4799729
Ext
4208
Email
edchang31@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yei-San Hsieh, MD
Organizational Affiliation
Taoyan General Hospital, Ministry of Health and Welfare
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32802440
Citation
Chang H, Liao KS, Hsieh YS. Bronchoscopic light delivery method for peripheral lung cancer photodynamic therapy. J Thorac Dis. 2020 Jul;12(7):3611-3621. doi: 10.21037/jtd-19-3887.
Results Reference
result
PubMed Identifier
14688713
Citation
Friedberg JS, Skema C, Burdick J, Yodh AG, Carr SR, Culver JP. A novel technique for light delivery through branched or bent anatomic structures. J Thorac Cardiovasc Surg. 2003 Dec;126(6):1963-7. doi: 10.1016/s0022-5223(03)01320-5.
Results Reference
result
PubMed Identifier
29732193
Citation
Chen KC, Lee JM. Photodynamic therapeutic ablation for peripheral pulmonary malignancy via electromagnetic navigation bronchoscopy localization in a hybrid operating room (OR): a pioneering study. J Thorac Dis. 2018 Apr;10(Suppl 6):S725-S730. doi: 10.21037/jtd.2018.03.139.
Results Reference
result
Links:
URL
https://clinicaltrials.gov/ct2/show/results/NCT02916745
Description
Feasibility Study of Using Navigational Bronchoscopy to Perform PDT-Photofrin® in Unresectable Peripheral Lung Cancer
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Novel Light Delivery Methods for Lung Cancer Photodynamic Therapy - A Pilot Study
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