NCT04753918

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Mar 2021

Shorter than P25 for early_phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

February 15, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

February 9, 2021

Last Update Submit

February 9, 2021

Conditions

Non-small Cell Lung Cancer (NSCLC)Lung Metastasis

Keywords

Photodynamic TherapyPeripheral Lung cancer

Outcome Measures

Primary Outcomes (2)

  • Feasibility to Perform Novel Photodynamic Therapy Into Tumor

    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

    The incidence of adverse events following Novel PDT will be presented as the primary safety indicator for this treatment.

    Up to 6 months

Secondary Outcomes (2)

  • Tumor Response at 3 Months Post Photodynamic Therapy (PDT)

    Up to 3 months

  • Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT)

    From the start of treatment until 6 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria

Study Arms (1)

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

Drug: Porfimer sodiumDrug: Ethiodized oilProcedure: Novel light delivery methods of photodynamic therapyDevice: Fiber optic

Interventions

Porfimer sodiumDRUG

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

Also known as: Photofrin
Novel light delivery methods for photodynamic therapy
Ethiodized oilDRUG

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.

Also known as: Lipiodol
Novel light delivery methods for photodynamic therapy
Novel light delivery methods of photodynamic therapyPROCEDURE

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

Novel light delivery methods for 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.

Novel light delivery methods for photodynamic therapy

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 32802440RESULT

  • 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.

    PMID: 14688713RESULT

  • 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.

    PMID: 29732193RESULT

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Dihematoporphyrin EtherEthiodized OilOptical Fibers

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hematoporphyrin DerivativeHematoporphyrinsPorphyrinsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic CompoundsPigments, BiologicalBiological FactorsIodized OilPlant OilsOilsLipidsPlant PreparationsBiological ProductsComplex MixturesOptical DevicesEquipment and Supplies

Study Officials

  • Yei-San Hsieh, MD

    Taoyan General Hospital, Ministry of Health and Welfare

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yei-San Hsieh, MD

CONTACT

886-975061108yeisanh@gmail.com

Hwailuh Chang, MD

CONTACT

886-3-4799729edchang31@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2021

First Posted

February 15, 2021

Study Start

March 1, 2021

Primary Completion

September 1, 2021

Study Completion

February 1, 2022

Last Updated

February 15, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share