Novel Light Delivery Methods for Lung Cancer Photodynamic Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-31

Study Completion Date

2022-02-28

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Non-small Cell Lung Cancer (NSCLC) Lung Metastasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Porfimer sodium

Intervention Type DRUG

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

Ethiodized oil

Intervention Type DRUG

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 therapy

Intervention Type PROCEDURE

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

Fiber optic

Intervention Type DEVICE

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

Interventions

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Porfimer sodium

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

Intervention Type 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.

Intervention Type DRUG

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

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

Other Intervention Names

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Photofrin Lipiodol

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No