Lung CancerPhase 1NCT03344861
Safety of PDT-Photofrin® Prior to Lung Surgery
A Phase 1 study testing Porfimer Sodium and Fiber optic in people with Lung Cancer and Lung Cancer Metastatic, run by Concordia Laboratories Inc. at 8 sites in United States.
Trial summary
This research study is being conducted to assess the safety of PDT in subjects with peripherally located malignant tumors in lung parenchyma prior to surgical resection. It will involve up to 10 sites in USA. Participation will last 4 months. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Lung Cancer, Lung Cancer Metastatic
- What is being tested?
- Porfimer Sodium and Fiber optic
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 8 sitesUnited States
- Study dates
- 14 Aug 2017to 22 Mar 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18-79
- Diagnosed with primary or metastatic tumor < 5 cm located in peripheral lung that can be completely resectable
- Candidate for surgical resection
- Candidate for bronchoscopy
- Tumor is accessible for unrestricted illumination of PDT
- Subject is deemed likely to survive for at least 3 months
Show all 9Show fewer
- Non-menopausal/non-sterile female subject of childbearing potential has negative B-HCG (Human chorionic gonadotropin) at time of study entry
- Non-menopausal/non-sterile female subject of childbearing potential uses medically acceptable form of birth control
- Subject is able and willing to provide written informed consent to participate in the study, which must comply with ICH (International Council for Harmonisation) guidelines \& local requirements
Who cannot join
- Diagnosis of small cell lung cancer or carcinoid tumors
- Primary or metastatic lung tumor located in central lung or near vertebral body
- Tumor invades a major blood vessel
- Presence of concurrent non-solid malignancy
- Tumor previously treated with radiation therapy
- Chemotherapy in the last four weeks
Show all 13Show fewer
- Tumor treated with PDT within the last 3 months
- Abnormal blood results
- Subject with porphyria or hypersensitivity to Photofrin
- Coexisting ophthalmic disease likely to required slit-lamp exam within next 90 days
- Acute or chronic medical or psychological illness as judged clinical significant to PI to preclude bronchoscopy procedures
- female who is breast-feeding or intends to breast-feed during study
- subject who participated in another study within last 30 days or intends to participate in another study during this study
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Cancer Treatment Centers of America/Southeastern
Atlanta, Georgia, 30265
University of Colorado
Denver, Colorado, 80045
Dubois Medical Center
DuBois, Pennsylvania, 15801
AMITA Health Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
UT MD Anderson Cancer Center
Houston, Texas, 77030
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Providence Health & Services
Spokane, Washington, 99204
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: A Multicenter, Prospective, Open-label, Non-randomized Single-arm Clinical Study of the Safety and Tissue Response to Photodynamic Therapy Using Porfimer Sodium for Injection as Treatment for Solid Lung Tumor Prior to Surgical Resection
This research study is being conducted to assess the safety of PDT in subjects with peripherally located malignant tumors in lung parenchyma prior to surgical resection. It will involve up to 10 sites in USA. Participation will last 4 months.
Read the 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 been 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 lightning the abnormal area using a fiber optic device (very fine fiber [like a fishing line] that permits light transmission) inserted into a flexible tube with a light, called bronchoscope for the lung. The light activates the porfimer sodium concentrated in the abnormal tissue, leading to its destruction.
The purpose of this study is to assess the safety of using photodynamic therapy prior to surgical resection of tumors located in the periphery of the lung.
- Conditions
- Lung Cancer, Lung Cancer Metastatic
- Being tested
- Porfimer Sodium, Fiber optic
- Keywords
- lung cancer, lung carcinoma, lung metastases
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Porfimer SodiumDrug
Also called Photofrin
Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
Fiber opticDevice
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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
| Study group | Role | What they receive |
|---|---|---|
| Photodynamic therapy-Photofrin | Experimental | Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Receives: Drug: Porfimer Sodium; Device: Fiber optic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Number of Participants With at Least One Adverse Event
Safety evaluation will include incidence of all adverse events, including serious and non-serious. The count of how many subjects experienced at least one adverse event.
Measured: 108 days (to 3 months post surgery)
Safety: Physical Examination Summaries of Non-normal Findings for Each Subject
Safety evaluation will include the physical examinations summary of non-normal findings for each subject.
Measured: 108 days (to 3 months post surgery)
Safety: Vital Sign Summary of Abnormal Findings for Each Subject
Safety evaluation will include vital sign summary for each subject. Only abnormal counts are included.
Measured: 108 days (to 3 months post surgery)
Safety: Laboratory Tests Summaries of Abnormal Findings for Each Subject
Safety evaluation will include laboratory tests summarized for each subject with any abnormal lab results considered an AE (adverse event) to be listed.
Measured: 108 days (to 3 months post surgery)
Safety: Skin Photosensitivity Events Summaries of Abnormal Findings for Each Subject
Safety evaluation will include incidence of skin photosensitivity summarized for each subject.
Measured: 108 days (to 3 months post surgery)
Secondary outcomes (21)
Macroscopic Tissue Examination
The mean measurement of tumor size after surgery. The largest diameter seen is measured.
Measured: Day 13 to 18
Summary of Microscopic Tissue Examination: Percentage of Participants With Complete Response After Surgery
The Percentage of Participants with Complete Response in Tumor area (no non-viable/necrotic tumor) after surgery
Measured: Day 13 to 18
Microscopic Tissue Examination: Percent Tumor Cell Necrosis in Tumor Area After Surgery
The mean with standard deviation of the percent of tumor cell necrosis in the tumor area after surgery. The tumor itself was examined after it was removed to determine the percent of necrosis seen.
Measured: Day 13 to 18
Microscopic Tissue Examination: Brisk Inflammatory Reaction After Surgery
The number of participants showing a brisk inflammatory reaction in the tumor area after surgery. This is determined through a histological examination. Brisk Inflammatory Reaction is defined as lymphocytes that infiltrate diffusely the entire tumor and/or infiltrate across the entire base of the tumor.
Measured: Day 13 to 18
Microscopic Tissue Examination: Number of Participants With Cavitation in Normal Lung Area After Surgery
The number of participants with cavitation seen in the normal lung area from the microscopic tissue examination after surgery
Measured: Day 13 to 18
Microscopic Tissue Examination: Number of Participants With Hemorrhage Seen After Surgery
The Number of Participants with hemorrhage seen during the microscopic tissue examination after surgery
Measured: Day 13 to 18
Microscopic Tissue Examination: Number of Participants With Pneumonitis in the Normal Lung After Surgery
The Number of Participants with pneumonitis seen in the normal lung area after surgery following the microscopic tissue examination
Measured: Day 13 to 18
Microscopic Tissue Examination: Number of Participants With Increased Alveolar Macrophages in the Normal Lung After Surgery
The number of participants with increased alveolar macrophages post surgery determined in the microscopic tissue examination.
Measured: Day 13 to 18
Microscopic Tissue Examination: Number of Participants With Atypical/Reactive Type 2 Pneumocytes in the Normal Lung After Surgery
Number of Participants with Atypical/Reactive Type 2 pneumocytes seen in the normal lung after surgery during the Microscopic Tissue Examination:
Measured: Day 13 to 18
Microscopic Tissue Examination: Number of Participants With Mucus Plugging/Mucositis in the Normal Lung After Surgery
Number of Participants with Mucus Plugging/Mucositis seen in the normal lung after surgery during the Microscopic Tissue Examination.
Measured: Day 13 to 18
Microscopic Tissue Examination: Number of Participants With Interstitial Fibrosis in the Normal Lung After Surgery
Number of participants with interstitial fibrosis in the normal lung after surgery seen during the Microscopic Tissue Examination
Measured: Day 13 to 18
Microscopic Tissue Examination: Number of Participants With Necrosis in the Normal Lung After Surgery
Number of Participants with Necrosis seen in the normal lung after surgery during the Microscopic Tissue Examination
Measured: Day 13 to 18
Microscopic Tissue Examination: Number of Participants With Large Vessel Damage Indicated by Fibrinoid Necrosis, Thrombus, Vasculitis in the Normal Lung After Surgery
Number of Participants with Large Vessel Damage indicated by fibrinoid necrosis, thrombus, vasculitis in the normal lung after surgery seen during Microscopic Tissue Examination
Measured: Day 13 to 18
Microscopic Tissue Examination: Number of Participants With Acute Alveolar Damage in the Normal Lung After Surgery
Number of Participants with Acute Alveolar damage in the normal lung after surgery seen during the Microscopic Tissue Examination
Measured: Day 13 to 18
Microscopic Tissue Examination: Number of Participants With Organizing Pneumonia Pattern in the Normal Lung After Surgery
Number of Participants with Organizing pneumonia pattern in the normal lung after surgery seen during Microscopic Tissue Examination
Measured: Day 13 to 18
ECOG (Eastern Cooperative Oncology Group) Performance Status: Baseline
Number of Participants with ECOG Performance at Baseline showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Measured: Baseline (-30 to -1 Days)
ECOG Performance Status: Period 1 PDT Day 3
Number of Participants with ECOG Performance Status at Period 1 PDT Day 3, showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Measured: Day 3
ECOG Performance Status: Period II Surgery (Day 13-18)
Number of Participants with ECOG Performance Status at Period II Surgery (Day 13-18) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Measured: Day 13 to 18
ECOG Performance Status: Period III Follow-up (Day 20-25)
Number of Participants with ECOG Performance Status at Period III Follow-up (Day 20-25) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Measured: Day 20 to 25
ECOG Performance Status: Period III Follow-up (Day 43 -48)
Number of Participants with ECOG Performance Status at Period III Follow-up (Day 43 -48) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Measured: Day 43 to 48
ECOG Performance Status: Period III Follow-up (Day 103 - 108)
Number of Participants with ECOG Performance Status at Period III Follow-up (Day 103 - 108) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Measured: 108 days (to 3 months post surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start14 Aug 2017
- Primary completion22 Mar 2019
- Study completion22 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concordia Laboratories Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erin O'Neil, Study chair, Concordia Laboratories Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344861
- Sponsor's protocol ID
- CLI-PHO1701
- Status last verified
- Dec 2019
- First submitted
- 13 Nov 2017
- Last updated
- 13 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a phase 2 study with only 10 subjects which is of minor use to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Open-label, Non-randomized Single-arm Clinical Study of the Safety and Tissue Response to Photodynamic Therapy Using Porfimer Sodium for Injection as Treatment for Solid Lung Tumor Prior to Surgical Resection
- ClinicalTrials.gov ID
- NCT03344861
- Acronym / sponsor ID
- CLI-PHO1701
- Conditions
- Lung Cancer, Lung Cancer Metastatic
- Keywords
- lung cancer, lung carcinoma, lung metastases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Concordia Laboratories Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 22 Mar 2019 (actual)
- Study completion
- 22 Mar 2019 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Posted 2 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is being conducted to assess the safety of PDT in subjects with peripherally located malignant tumors in lung parenchyma prior to surgical resection. It will involve up to 10 sites in USA. Participation will last 4 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 been 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 lightning the abnormal area using a fiber optic device (very fine fiber [like a fishing line] that permits light transmission) inserted into a flexible tube with a light, called bronchoscope for the lung. The light activates the porfimer sodium concentrated in the abnormal tissue, leading to its destruction.
The purpose of this study is to assess the safety of using photodynamic therapy prior to surgical resection of tumors located in the periphery of the lung.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photodynamic therapy-Photofrin | Experimental | Drug: Porfimer Sodium, Device: Fiber opticPhotodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female aged 18-79
- Diagnosed with primary or metastatic tumor < 5 cm located in peripheral lung that can be completely resectable
- Candidate for surgical resection
- Candidate for bronchoscopy
- Tumor is accessible for unrestricted illumination of PDT
Key exclusion criteria (13 listed)
- Diagnosis of small cell lung cancer or carcinoid tumors
- Primary or metastatic lung tumor located in central lung or near vertebral body
- Tumor invades a major blood vessel
- Presence of concurrent non-solid malignancy
- Tumor previously treated with radiation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Porfimer SodiumAlso: PhotofrinPorfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. | Drug | Photodynamic therapy-Photofrin |
| Fiber opticAfter 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length. | Device | Photodynamic therapy-Photofrin |
Primary outcome
Safety: Number of Participants With at Least One Adverse Event
Time frame: 108 days (to 3 months post surgery)
Safety evaluation will include incidence of all adverse events, including serious and non-serious. The count of how many subjects experienced at least one adverse event.
Safety: Physical Examination Summaries of Non-normal Findings for Each Subject
Time frame: 108 days (to 3 months post surgery)
Safety evaluation will include the physical examinations summary of non-normal findings for each subject.
Safety: Vital Sign Summary of Abnormal Findings for Each Subject
Time frame: 108 days (to 3 months post surgery)
Safety evaluation will include vital sign summary for each subject. Only abnormal counts are included.
Safety: Laboratory Tests Summaries of Abnormal Findings for Each Subject
Time frame: 108 days (to 3 months post surgery)
Safety evaluation will include laboratory tests summarized for each subject with any abnormal lab results considered an AE (adverse event) to be listed.
Safety: Skin Photosensitivity Events Summaries of Abnormal Findings for Each Subject
Time frame: 108 days (to 3 months post surgery)
Safety evaluation will include incidence of skin photosensitivity summarized for each subject.
21 secondary outcomes
Macroscopic Tissue Examination
Time frame: Day 13 to 18
Summary of Microscopic Tissue Examination: Percentage of Participants With Complete Response After Surgery
Time frame: Day 13 to 18
Microscopic Tissue Examination: Percent Tumor Cell Necrosis in Tumor Area After Surgery
Time frame: Day 13 to 18
Microscopic Tissue Examination: Brisk Inflammatory Reaction After Surgery
Time frame: Day 13 to 18
Microscopic Tissue Examination: Number of Participants With Cavitation in Normal Lung Area After Surgery
Time frame: Day 13 to 18
Microscopic Tissue Examination: Number of Participants With Hemorrhage Seen After Surgery
Time frame: Day 13 to 18
Microscopic Tissue Examination: Number of Participants With Pneumonitis in the Normal Lung After Surgery
Time frame: Day 13 to 18
Microscopic Tissue Examination: Number of Participants With Increased Alveolar Macrophages in the Normal Lung After Surgery
Time frame: Day 13 to 18
Microscopic Tissue Examination: Number of Participants With Atypical/Reactive Type 2 Pneumocytes in the Normal Lung After Surgery
Time frame: Day 13 to 18
Microscopic Tissue Examination: Number of Participants With Mucus Plugging/Mucositis in the Normal Lung After Surgery
Time frame: Day 13 to 18
Microscopic Tissue Examination: Number of Participants With Interstitial Fibrosis in the Normal Lung After Surgery
Time frame: Day 13 to 18
Microscopic Tissue Examination: Number of Participants With Necrosis in the Normal Lung After Surgery
Time frame: Day 13 to 18
Microscopic Tissue Examination: Number of Participants With Large Vessel Damage Indicated by Fibrinoid Necrosis, Thrombus, Vasculitis in the Normal Lung After Surgery
Time frame: Day 13 to 18
Microscopic Tissue Examination: Number of Participants With Acute Alveolar Damage in the Normal Lung After Surgery
Time frame: Day 13 to 18
Microscopic Tissue Examination: Number of Participants With Organizing Pneumonia Pattern in the Normal Lung After Surgery
Time frame: Day 13 to 18
ECOG (Eastern Cooperative Oncology Group) Performance Status: Baseline
Time frame: Baseline (-30 to -1 Days)
ECOG Performance Status: Period 1 PDT Day 3
Time frame: Day 3
ECOG Performance Status: Period II Surgery (Day 13-18)
Time frame: Day 13 to 18
ECOG Performance Status: Period III Follow-up (Day 20-25)
Time frame: Day 20 to 25
ECOG Performance Status: Period III Follow-up (Day 43 -48)
Time frame: Day 43 to 48
ECOG Performance Status: Period III Follow-up (Day 103 - 108)
Time frame: 108 days (to 3 months post surgery)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. This is a phase 2 study with only 10 subjects which is of minor use to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin O'Neil study chair
Concordia Laboratories Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Porfimer Sodium and Fiber optic in people with Lung Cancer and Lung Cancer Metastatic, run by Concordia Laboratories Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Number of Participants With at Least One Adverse Event (time frame: 108 days (to 3 months post surgery)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.