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

February 9, 2021 updated by: Taoyuan General Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

3

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Novel light delivery methods for photodynamic therapy
High refraction-index contrast medium: Lipiodol injected in the bronchial tree can enhance the treatment extension of the photodynamic therapy
Drug: Porfimer sodium
Photofrin 2mg/kg was iv injected 48-50 hours before light illumination.
Other Names:
  • Photofrin
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.
Other Names:
  • Lipiodol
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 3 post-treatment
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.
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor Response at 3 Months Post Photodynamic Therapy (PDT)
Time Frame: Up to 3 months
From the start of treatment until 3 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
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
Up to 6 months
From the start of treatment until 6 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taoyuan General Hospital

Investigators

  • Principal Investigator: Yei-San Hsieh, MD, Taoyan General Hospital, Ministry of Health and Welfare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2021

Primary Completion (ANTICIPATED)

September 1, 2021

Study Completion (ANTICIPATED)

February 1, 2022

Study Registration Dates

First Submitted

February 9, 2021

First Submitted That Met QC Criteria

February 9, 2021

First Posted (ACTUAL)

February 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TYGH107071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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