Non-small Cell Lung Cancer (NSCLC)Early Phase 1NCT04753918
Novel Light Delivery Methods for Lung Cancer Photodynamic Therapy - A Pilot Study
A Early Phase 1 study testing Porfimer sodium, Ethiodized oil and Novel light delivery methods of photodynamic therapy in people with Non-small Cell Lung Cancer (NSCLC) and Lung Metastasis, run by Taoyuan General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC), Lung Metastasis
- What is being tested?
- Porfimer sodium, Ethiodized oil and Novel light delivery methods of photodynamic therapy
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Feb 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this 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
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.
Read the 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
- Being tested
- Porfimer sodium, Ethiodized oil, Novel light delivery methods of photodynamic therapy, Fiber optic
- Keywords
- Photodynamic Therapy, Peripheral Lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Porfimer sodiumDrug
Also called Photofrin
Photofrin 2mg/kg was iv injected 48-50 hours before light illumination.
Ethiodized oilDrug
Also called Lipiodol
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.
Novel light delivery methods of photodynamic therapyProcedure or surgery
Using high-refraction index contrast medium: lipiodol as a light diffusor to enhance the range of photodynamic therapy
Fiber opticDevice
A cylindrical laser fiber was then inserted through the guide sheath to the tumor region then illuminate light to complete the photodynamic therapy.
| Study group | Role | What they receive |
|---|---|---|
| Novel light delivery methods for photodynamic therapy | Experimental | High refraction-index contrast medium: Lipiodol injected in the bronchial tree can enhance the treatment extension of the photodynamic therapy Receives: Drug: Porfimer sodium; Drug: Ethiodized oil; Procedure: Novel light delivery methods of photodynamic therapy; Device: Fiber optic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility to Perform Novel Photodynamic Therapy Into Tumor
Number of times photodynamic therapy was delivered into the tumor using navigational bronchoscopy for each subject.
Measured: Day 3 post-treatment
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.
Measured: Up to 6 months
Secondary outcomes (2)
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
Measured: Up to 3 months
Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT)
Up to 6 months
Measured: From the start of treatment until 6 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study startMar 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taoyuan General Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yei-San Hsieh, MD, Principal investigator, Taoyan General Hospital, Ministry of Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753918
- Sponsor's protocol ID
- TYGH107071
- Status last verified
- Feb 2021
- First submitted
- 9 Feb 2021
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32802440Friedberg 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.
PubMed 14688713Chen 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.
PubMed 29732193
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04753918
- Acronym / sponsor ID
- TYGH107071
- Keywords
- Photodynamic Therapy, Peripheral Lung cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Taoyuan General HospitalOther government
- Study start
- Mar 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novel light delivery methods for photodynamic therapy | Experimental | Drug: Porfimer sodium, Drug: Ethiodized oil, Procedure: Novel light delivery methods of photodynamic therapy, Device: Fiber opticHigh refraction-index contrast medium: Lipiodol injected in the bronchial tree can enhance the treatment extension of the photodynamic therapy |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Porfimer sodiumAlso: PhotofrinPhotofrin 2mg/kg was iv injected 48-50 hours before light illumination. | Drug | Novel light delivery methods for photodynamic therapy |
| Ethiodized oilAlso: LipiodolIn 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. | Drug | Novel light delivery methods for photodynamic therapy |
| Novel light delivery methods of photodynamic therapyUsing high-refraction index contrast medium: lipiodol as a light diffusor to enhance the range of photodynamic therapy | Procedure or surgery | Novel light delivery methods for photodynamic therapy |
| Fiber opticA cylindrical laser fiber was then inserted through the guide sheath to the tumor region then illuminate light to complete the photodynamic therapy. | Device | Novel light delivery methods for photodynamic therapy |
Primary outcome
Feasibility to Perform Novel Photodynamic Therapy Into Tumor
Time frame: Day 3 post-treatment
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
Time frame: Up to 6 months
The incidence of adverse events following Novel PDT will be presented as the primary safety indicator for this treatment.
2 secondary outcomes
Tumor Response at 3 Months Post Photodynamic Therapy (PDT)
Time frame: Up to 3 months
Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT)
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Results publication: PubMed 32802440Chang 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 publication: PubMed 14688713Friedberg 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 publication: PubMed 29732193Chen 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.
- Feasibility Study of Using Navigational Bronchoscopy to Perform PDT-Photofrin® in Unresectable Peripheral Lung CancerLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yei-San Hsieh, MD principal investigator
Taoyan General Hospital, Ministry of Health and Welfare
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Porfimer sodium, Ethiodized oil and Novel light delivery methods of photodynamic therapy in people with Non-small Cell Lung Cancer (NSCLC) and Lung Metastasis, run by Taoyuan General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yei-San Hsieh, MD (886-975061108, yeisanh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility to Perform Novel Photodynamic Therapy Into Tumor (time frame: Day 3 post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04753918, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2021.