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Feasibility Study of Using Navigational Bronchoscopy to Perform PDT-Photofrin® in Unresectable Peripheral Lung Cancer

Primary Purpose

Non-small Cell Lung Cancer (NSCLC), Lung Metastasis

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Porfimer sodium

Fiber optic

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer (NSCLC) focused on measuring Non-small cell lung cancer, NSCLC, lung cancer, lung carcinoma, lung metastasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female aged 18 or older
Diagnosed with histologically confirmed solid tumor located in the peripheral lung
Not candidate for curative surgery, is unfit for surgery, or does not wish to undergo curative surgery
May be candidate for, have failed, or does not wish to undergo radiation therapy
The tumor is ≤ 3 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
Solid tumor located in central lung
Presence of concurrent non-solid malignancy
Abnormal blood results
Received chemotherapy/immunotherapy in the last 4 weeks
Tumor invades a major blood vessel
Porphyria or known hypersensitivity to Photofrin® or porphyrin-like compounds or to any of its excipients
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 3 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

Sites / Locations

University of Florida
Southeastern Regional Medical Center
Alexian Brothers Hospital Network
Southwestern Regional Medical Center
Providence Medical Research Center
University of Wisconsin-Madison
Toronto General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Photodynamic therapy-Photofrin

Arm Description

Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.

Outcomes

Primary Outcome Measures

Feasibility to Perform Interstitial-Photodynamic Therapy (i-PDT) Into Tumor

Number of times photodynamic therapy was delivered into the tumor using navigational bronchoscopy for each subject.

Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT)

The incidence of adverse events following navigational bronchoscopy-iPDT (interstitial-Photodynamic Therapy) will be presented as the primary safety indicator for this treatment.

Secondary Outcome Measures

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

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

Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Screening (Days -14 to -1). Baseline.

Measured at screening to be the baseline measure. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.

Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 1 (Date of Photofrin Injection).

Measured at Day 1 which is day of the photofrin injection. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.

Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 3 (Day of Photodynamic Therapy)

Measured at Day 3. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.

Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 30 (30 Days Post Photofrin Injection)

Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 3 Months Post Photofrin Injection

Measured at 3 months. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.

Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 6 Months Post Photofrin Injection

Measured at 6 months. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.

Short Form Health Survey (SF-36) Score at Baseline

The Short-Form Health Survey (SF-36) scores range from 0 to 100, with higher scores indicating better health status. SF-36 evaluates 9 dimensions of Health: physical function, role limitations due to physical health problems, body pain, general health, vitality, social functioning, role limitations due to emotional problems domain, and mental health. Summary is provided in the form of physical component score (PCS) and mental component score (MCS) for each of the timepoints.

Short-Form Health Survey (SF-36) Score at Follow-up Visit at 3 Months.

Short-Form Health Survey (SF-36) Score at Study Exit (6 Month Visit)

Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline

Baseline score of EORTC QLQ-C30 which is a multi-dimensional Health Related Quality of Life measure designed for use in lung cancer patients. Includes 5 functional measures (physical, role, emotional, social, cognitive), 8 symptoms (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea) and global health status and financial impact. Most items use 4-item scale from "not at all" to "very much". Raw scores are transformed to 0-100 scale with higher scores representing better functioning/Quality of Life and greater symptom burden.

Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months

3 month score of EORTC QLQ-C30 which is a multi-dimensional Health Related Quality of Life measure designed for use in lung cancer patients. Includes 5 functional measures (physical, role, emotional, social, cognitive), 8 symptoms (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea) and global health status and financial impact. Most items use 4-item scale from "not at all" to "very much". Raw scores are transformed to 0-100 scale with higher scores representing better functioning/Quality of Life and greater symptom burden.

Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months

6 month score of EORTC QLQ-C30 which is a multi-dimensional Health Related Quality of Life measure designed for use in lung cancer patients. Includes 5 functional measures (physical, role, emotional, social, cognitive), 8 symptoms (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea) and global health status and financial impact. Most items use 4-item scale from "not at all" to "very much". Raw scores are transformed to 0-100 scale with higher scores representing better functioning/Quality of Life and greater symptom burden.

Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score

Baseline measure for EORTC QLQ-LC13 which is a 13-item lung cancer-specific questionnaire module. It is used in conjunction with the QLQ-C30. It is comprised of multi-item and single-item measures of lung cancer associated symptoms (coughing, hemoptysis, dyspnea, pain) and side effects from conventional chem-and radiotherapy (alopecia, neuropathy, sore mouth, dysphagia). For these symptom-oriented scales, a higher score means more severe symptoms. The scale is from 1 (not at all) to 4 (very much). The scoring (as reported here) is from 0 to 100 with the higher score meaning a more severe symptom.

Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score

3-Month measure for EORTC QLQ-LC13 which is a 13-item lung cancer-specific questionnaire module. It is used in conjunction with the QLQ-C30. It is comprised of multi-item and single-item measures of lung cancer associated symptoms (coughing, hemoptysis, dyspnea, pain) and side effects from conventional chem-and radiotherapy (alopecia, neuropathy, sore mouth, dysphagia). For these symptom-oriented scales, a higher score means more severe symptoms. The scale is from 1 (not at all) to 4 (very much). The scoring (as reported here) is from 0 to 100 with the higher score meaning a more severe symptom.

6-Month measure for EORTC QLQ-LC13 which is a 13-item lung cancer-specific questionnaire module. It is used in conjunction with the QLQ-C30. It is comprised of multi-item and single-item measures of lung cancer associated symptoms (coughing, hemoptysis, dyspnea, pain) and side effects from conventional chem-and radiotherapy (alopecia, neuropathy, sore mouth, dysphagia). For these symptom-oriented scales, a higher score means more severe symptoms. The scale is from 1 (not at all) to 4 (very much). The scoring (as reported here) is from 0 to 100 with the higher score meaning a more severe symptom.

Number of Participants With Indicated Adverse Events

Adverse events (AEs) noted by number of participants with at least one event. An AE was defined as any untoward medical occurrence in a subject during the course of the study, regardless of causal relationship. AEs were coded using MedDRA Version 21.1

Number of Subjects With at Least One Serious Adverse Event

The number of subjects with at least one serious adverse event are listed.

Safety: Physical Examination Summaries for Each Subject

Safety evaluation will include the physical examinations summary of non-normal findings for each subject.

Safety: Number of Participants With Indicated Vital Sign Summaries

Safety evaluation included vital sign summary for each subject. Vital signs included pulse, blood pressure, temperature and respiration rate. Only clinically relevant results, as per the investigator judgement, are included. These would be vital signs that are out of the normal range but could be considered outside enough to be clinically relevant to the subject's health.

Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events

The treatment emergent adverse events related to PFTs are noted. Pulmonary function test measurements were: Diffusion Capacity of Lung for Carbon Monoxide (%), Expiratory Reserve Volume (mL), Forced Vital Capacity (mL), Forced Expiratory Volume in 1 second (mL), Forced Expiratory Flow 25% to 75% (L/min), Functional Residual Capacity (mL), Maximum Voluntary Ventilation (L/min), Residual Volume (mL), Peak Expiratory Flow (L/min), Slow Vital Capacity (mL), Total Lung Capacity (mL)

Safety: Laboratory Test Summaries for Each Subject

Safety evaluation includes laboratory tests summarized for each subject with any abnormal lab results considered an Adverse Event to be listed. The investigators commented on any laboratory value outside the normal reference range. If the value was judged to be an Adverse Event, it is listed. The values analysed were: Hematology (Hemoglobin, Hematocrit, White Blood Cell, Red Blood Cell, Platelet Count, Prothrombin Time) and Chemistry (Glucose (random), Blood Urea Nitrogen, Electrolytes (sodium, potassium, chloride), Creatinine, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase, Total Bilirubin, Albumin, Total Protein)

Full Information

NCT ID

NCT02916745

First Posted

September 26, 2016

Last Updated

February 24, 2020

Sponsor

Concordia Laboratories Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02916745

Brief Title

Feasibility Study of Using Navigational Bronchoscopy to Perform PDT-Photofrin® in Unresectable Peripheral Lung Cancer

Official Title

Multicenter, Prospective, OL, Single-arm Clinical Study of Safety & Feasibility of Using Navigational Bronchoscopy to Perform Interstitial PD Therapy Using Photofrin® as Treatment in Subjects With Unresectable Solid Tumor in Peripheral Lung

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

January 26, 2017 (Actual)

Primary Completion Date

April 12, 2019 (Actual)

Study Completion Date

April 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Concordia Laboratories Inc.

4. Oversight

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.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This research study is being conducted to assess the safety and feasibility of using a new developed bronchoscopic technology called electronavigational bronchoscopy to treat subjects with solid tumor in peripheral lung, who are inoperable or refused surgery. It will involve 10 sites in USA and Canada. Participation will last 6 months.

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) have shown to enable physicians to safely reach lesions in peripheral regions of the lung and obtain 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 bronchoscope. The light activates the porfimer sodium, which is concentrated in the abnormal tissue, leading to its destruction. The purpose of this study is to determine if physicians can reach the tumors in the periphery of the lung via electronavigational bronchoscopy and deliver the photodynamic therapy by placing the optical fiber into the tumor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer (NSCLC), Lung Metastasis

Keywords

Non-small cell lung cancer, NSCLC, lung cancer, lung carcinoma, lung metastasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Photodynamic therapy-Photofrin

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Porfimer sodium

Other Intervention Name(s)

Photofrin

Intervention Description

After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.

Intervention Type

Device

Intervention Name(s)

Fiber optic

Intervention Description

A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.

Primary Outcome Measure Information:

Title

Feasibility to Perform Interstitial-Photodynamic Therapy (i-PDT) Into Tumor

Description

Number of times photodynamic therapy was delivered into the tumor using navigational bronchoscopy for each subject.

Time Frame

Day 3 post-treatment

Title

Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT)

Description

The incidence of adverse events following navigational bronchoscopy-iPDT (interstitial-Photodynamic Therapy) will be presented as the primary safety indicator for this treatment.

Time Frame

Up to 6 months

Secondary Outcome Measure Information:

Title

Tumor Response at 3 Months Post Photodynamic Therapy (PDT)

Description

From the start of treatment until 3 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria

Time Frame

Up to 3 months

Title

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

Description

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

Time Frame

Up to 6 months

Title

Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Screening (Days -14 to -1). Baseline.

Description

Time Frame

up to day 0 (-14 to -1 days)

Title

Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 1 (Date of Photofrin Injection).

Description

Time Frame

1 day

Title

Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 3 (Day of Photodynamic Therapy)

Description

Time Frame

Day 3

Title

Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 30 (30 Days Post Photofrin Injection)

Description

Time Frame

Day 30

Title

Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 3 Months Post Photofrin Injection

Description

Time Frame

up to 3 months

Title

Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 6 Months Post Photofrin Injection

Description

Time Frame

Up to 6 months

Title

Short Form Health Survey (SF-36) Score at Baseline

Description

Time Frame

Baseline

Title

Short-Form Health Survey (SF-36) Score at Follow-up Visit at 3 Months.

Description

Time Frame

up to 3 months

Title

Short-Form Health Survey (SF-36) Score at Study Exit (6 Month Visit)

Description

Time Frame

Up to 6 months

Title

Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline

Description

Time Frame

Baseline

Title

Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months

Description

Time Frame

up to 3 months

Title

Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months

Description

Time Frame

Up to 6 months

Title

Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score

Description

Time Frame

Baseline

Title

Description

Time Frame

up to 3 months

Title

Description

Time Frame

Up to 6 months

Title

Number of Participants With Indicated Adverse Events

Description

Time Frame

Up to 6 months post-treatment

Title

Number of Subjects With at Least One Serious Adverse Event

Description

The number of subjects with at least one serious adverse event are listed.

Time Frame

Up to 6 months

Title

Safety: Physical Examination Summaries for Each Subject

Description

Safety evaluation will include the physical examinations summary of non-normal findings for each subject.

Time Frame

Up to 6 months

Title

Safety: Number of Participants With Indicated Vital Sign Summaries

Description

Time Frame

Up to 6 months

Title

Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events

Description

Time Frame

Up to 6 months

Title

Safety: Laboratory Test Summaries for Each Subject

Description

Time Frame

Up to 6 months

Other Pre-specified Outcome Measures:

Title

Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.

Description

Distribution of lymphocyte subsets from peripheral blood was determined by flow cytometry. Flow cytometry is a laser-based technique used to detect and measure physical and chemical characteristics of a population of cells or particles. It allows simultaneous multi-parameter analysis of single cells. The selected markers of interest, representative of the broader markers were: Total Thymus-cells (T-Cells), Cluster of Differentiation 4 (CD4) T cell subsets, and Cluster of Differentiation 9 (CD8) T cell subset, CD4 T Regulatory (T Reg) cells, Natural Killer Cells, Activated T cells, Myeloid-Derived Suppressor Cells (MSCDs), Monocytes. The Percent Gated and Absolute counts were analysed for each marker. Gating allows the analysis to be restricted to a specific size of cells (e.g. lymphocytes) to allow a more specific analysis. Absolute counting quantifies the total number of cells. It is recommended to look at both values to get the full picture.

Time Frame

Baseline, 10 days post-treatment

Title

Skin Photosensitivity as a Adverse Event of Special Interest: Participants With Event

Description

Adverse Event of special interest was Skin Photosensitivity. Skin photosensitivity was examined because all subjects who receive Photofrin are photosensitive and must observe precautions to avoid exposure of eyes and skin to direct sunlight or bright indoor lights for 30 days or longer. Changes in skin will be assessed by grade of erythema, edema and blistering and will be tabulated by Common Terminology Criteria for Adverse Events (CTCAE) grade in the dermatology/skin category.

Time Frame

Up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female aged 18 or older Diagnosed with histologically confirmed solid tumor located in the peripheral lung Not candidate for curative surgery, is unfit for surgery, or does not wish to undergo curative surgery May be candidate for, have failed, or does not wish to undergo radiation therapy The tumor is ≤ 3 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 Solid tumor located in central lung Presence of concurrent non-solid malignancy Abnormal blood results Received chemotherapy/immunotherapy in the last 4 weeks Tumor invades a major blood vessel Porphyria or known hypersensitivity to Photofrin® or porphyrin-like compounds or to any of its excipients 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 3 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michelle Depot, Ph.D.

Organizational Affiliation

at the request of Concordia Laboratories Inc.

Official's Role

Study Director

Facility Information:

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32611

Country

United States

Facility Name

Southeastern Regional Medical Center

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30265

Country

United States

Facility Name

Alexian Brothers Hospital Network

City

Elk Grove Village

State/Province

Illinois

ZIP/Postal Code

60007

Country

United States

Facility Name

Southwestern Regional Medical Center

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74133

Country

United States

Facility Name

Providence Medical Research Center

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

University of Wisconsin-Madison

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53715

Country

United States

Facility Name

Toronto General Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G2C4

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Feasibility Study of Using Navigational Bronchoscopy to Perform PDT-Photofrin® in Unresectable Peripheral Lung Cancer

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