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

Taoyuan General Hospital

Status and phase

Unknown

Early Phase 1

Conditions

Non-small Cell Lung Cancer (NSCLC)

Lung Metastasis

Treatments

Drug: Ethiodized oil

Drug: Porfimer sodium

Device: Fiber optic

Procedure: Novel light delivery methods of photodynamic therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04753918

TYGH107071

Details and patient eligibility

About

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.

Full 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

Enrollment

3 estimated patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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