Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Airway Obstruction

Respiratory Insufficiency

Respiration Disorders

Respiratory Tract Diseases

Dermatologic Agents

All Drugs and Chemicals

Verteporfin

Photosensitizing Agents

Patients receive visudyne IV over 10 minutes and then undergo I-PDT with EBUS 60-90 minutes after visudyne for up to 3 treatment sessions. Patients undergo blood and tissue sample collection on study. Patients also undergo CT throughout the trial.

Patients undergo SOC p-XRT over a single fraction. Patients receive visudyne IV over 10 minutes and then undergo I-PDT with EBUS 60-90 minutes after visudyne for up to 2 treatment sessions at least 12 weeks apart. Patients undergo blood and tissue sample collection on study. Patients also undergo CT throughout the trial.

Phase II: Patients undergo SOC p-XRT over a single fraction. Patients receive visudyne IV over 10 minutes and then undergo I-PDT with EBUS 60-90 minutes after visudyne for up to 2 treatment sessions at least 12 weeks apart. Patients undergo blood and tissue sample collection on study. Patients also undergo CT throughout the trial.

Undergo blood and tissue sample collection

Biospecimen Collection

Computed Tomography

Endobronchial Ultrasound Bronchoscopy

Interstitial Photodynamic Therapy

Palliative Radiation Therapy

Physical Performance Testing

Questionnaire Administration

Nathaniel Ivanick

This phase I/II trial studies the side effects of interstitial photodynamic therapy following palliative radiotherapy and how well it works in treating patients with inoperable malignant central airway obstruction. Patients who have advanced stage cancer tumors in the lung can often have the breathing passages to the lung partially or completely blocked. These tumors could be due to lung cancer or other cancers (e.g., renal, breast, kidney, etc.) that spread to the lung. This blockage puts the patient at a higher risk for respiratory failure, post-obstructive pneumonia, and prolonged hospitalizations. Treatment for these patients may include bronchoscopic intervention (such as mechanical removal, stenting, laser cauterization, or ballooning), radiation therapy with and without chemotherapy. While palliative x-ray radiotherapy may help in shrinking the tumor, high dose curative radiotherapy that can ablate (a localized, nonsurgical destruction) the tumor also has high risk to cause significant toxicity, including bleeding, abnormal connections or passageways between organs or vessels and abnormal scar tissue that can also produce airway obstruction. Photodynamic therapy (PDT) is another possible treatment that can provide local control of the tumor. PDT consists of injecting a light sensitive drug (photosensitizer, PS) into the vein, waiting for the PS to accumulate in the tumor, and then activating it with a red laser light. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving interstitial photodynamic therapy following palliative radiotherapy may improve tumor response and survival without the serious side effects that are associated with the typical high dose curative x-ray radiotherapy alone in patients with malignant central airway obstruction.

PRIMARY OBJECTIVES:

I. To test the safety of our image-based treatment planning for image-guided interstitial photodynamic therapy (I PDT) with endobronchial ultrasound (EBUS) following standard of care palliative radiotherapy (p-XRT). (Phase I) II. To assess the efficacy of our image-based treatment planning for image-guided I-PDT following standard of care p-XRT. (Phase II)

SECONDARY OBJECTIVES:

I. To assess objective tumor response. (Phase I) II. To evaluate changes in quality of life. (Phase I and II) III. To measure changes in functional lung capacity. (Phase I and II) IV. To measure the relationship between the measured objective tumor response (at 12 +/- 2 weeks post I-PDT) and changes in therapeutic laser light transmission within the target tumor, as a future dosimetric marker for response. (Phase I and II) V. To assess treatment effects on the immune contexture. (Phase I and II) VII. To monitor progression free survival. (Phase I and II)

OUTLINE: This is a phase I study, followed by a phase II.

PHASE I: Patients are assigned to 1 of 2 cohorts.

COHORT 1: Patients receive visudyne intravenously (IV) over 10 minutes and then undergo I-PDT with EBUS 60-90 minutes after visudyne for up to 3 treatment sessions. Patients undergo blood and tissue sample collection on study. Patients also undergo computed tomography (CT) throughout the trial.

COHORT 2: Patients undergo SOC p-XRT over a single fraction. Patients receive visudyne IV over 10 minutes and then undergo I-PDT with EBUS 60-90 minutes after visudyne for up to 2 treatment sessions at least 12 weeks apart. Patients undergo blood and tissue sample collection on study. Patients also undergo CT throughout the trial.

PHASE II: Patients undergo SOC p-XRT over a single fraction. Patients receive visudyne IV over 10 minutes and then undergo I-PDT with EBUS 60-90 minutes after visudyne for up to 2 treatment sessions at least 12 weeks apart. Patients undergo blood and tissue sample collection on study. Patients also undergo CT throughout the trial.

After completion of study treatment, patients are followed up at 30 days and 8, 12, and 24 weeks.

Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction

A Phase I/II Study of Interstitial Photodynamic Therapy Following Palliative Radiotherapy for Patients With Inoperable Malignant Central Airway Obstruction

Will will be associated with treatment related adverse events .grade 3 (with attribution of 'possible', 'probable' or 'definite'. Will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v 5.0).

Will be assessed by complete response (CR) or partial response (PR) defined by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) criteria.

Will be assessed by CR or PR defined by the RECIST v 1.1 criteria.

Will be monitored using the Functional Assessment of Cancer Therapy-Lung. This 36 item self-reported quality of life questionnaire measures responses across six domains: physical well-being, social/family well-being, relationship with doctor, emotional well-being, functional well-being, and additional concerns. This scale was chosen because multiple studies support its validity and use in clinical trials of lung cancer.

Will be measured with the six-minute walk test.

Will be measured with our light dosimetry system.

will be measured with flow cytometry in fresh blood samples collected prior and 30 days after the I-PDT.

Will be summarized using standard Kaplan-Meier methods.

Roswell Park Cancer Institute

Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Patients undergo RP-EBUS bronchoscopy per standard of care. If the study staff cannot reach the target lesion or is unable to determine a diagnosis, patients undergo bronchoscopy using mobile CT imaging. Patients' medical records are also reviewed for up to 6 months.

Electronic Health Record Review

Roberto F. Casal

Roberto F Casal

This study investigates whether using a mobile-CT-assisted bronchoscopy (M-CAB) during a bronchoscopy procedure will better enable the study staff to reach the lung tumor, perform a biopsy, and obtain a diagnosis. One method that doctors use for diagnosing lung tumors is bronchoscopy guided by an X-ray machine (called fluoroscope). Though much better guidance could be provided with a CT scanner when compared to the fluoroscope, the standard CT equipment is very large, fixed in a radiology room, and difficult to use with bronchoscopy. Mobile CT imaging systems may more easily and effectively perform the same tasks of the standard CT imaging in the bronchoscopy room, offering better guidance than the standard fluoroscope.

PRIMARY OBJECTIVE

I. To determine the added value of mobile-CT)-assisted bronchoscopy (M-CAB) for the diagnosis of peripheral lung nodules defined as the proportion of patients in whom bronchoscopy with radial-probe endobronchial ultrasound (RP-EBUS) and 2-D Fluoroscopy is non-diagnostic (lesion is not reached or rapid-onsite cytology is non-diagnostic) and diagnosis is obtained after utilizing mobile-CT assistance.

SECONDARY OBJECTIVES:

I. Describe the navigational yield of bronchoscopy with RP-EBUS/2-dimensional (2-D) fluoroscopy for peripheral nodules.

II. Describe the diagnostic yield of bronchoscopy with RP-EBUS/2-D fluoroscopy for peripheral nodules.

III. Describe the mobile-CT (M-CT) added navigational yield. IV. Describe the sensitivity for malignancy of bronchoscopy with RP-EBUS/2-D fluoroscopy and its increase (if any) provided by mobile-CT assistance.

V. Describe anatomical and procedural characteristics that can influence navigational and diagnostic yield (tumor location, tumor characteristics -solid, semisolid-, air-bronchus sign, biopsy tool, relationship between biopsy tool/tumor).

VI. Describe procedure duration. VII. Describe time required to obtain mobile CT scans VIII. Describe fluoroscopy time and estimate radiation dose to the patient. IX. Describe procedural complications.

OUTLINE:

Patients undergo RP-EBUS bronchoscopy per standard of care. If the study staff cannot reach the target lesion or is unable to determine a diagnosis, patients undergo bronchoscopy using mobile CT imaging. Patients' medical records are also reviewed for up to 6 months.

Feasibility of Mobile-CT-Assisted Bronchoscopy for the Diagnosis of Lung Lesion

Mobile-CT-Assisted Bronchoscopy

Defined as the proportion of patients in whom bronchoscopy with thin or ultrathin scope, radial-probe endobronchial ultrasound (RP-EBUS) and 2-dimensional (2-D) fluoroscopy is non-diagnostic (lesion is not reached or rapid-onsite cytology is non-diagnostic) and diagnosis is obtained after utilizing mobile-CT assistance. Descriptive statistics (mean standard deviation \[SD\] or median interquartile range \[IQR\], frequency \[%\]) will be used to summarize patient characteristics.

Navigational yield for standard of care (SOC) will be estimated along with 95% confidence intervals (CIs).

Diagnostic yield of SOC and diagnostic yield of SOC + M-CT along with their 95% CIs will be estimated.

M-CT added diagnostic yield in a subgroup with non-diagnostic subjects by SOC will be estimated along with its 95% CI. M-CT added diagnostic yield in a subgroup with non-diagnostic subjects by SOC will be estimated along with its 95% CI. Two-sided exact binomial test will be used to test if diagnostic yield of SOC + M-CT is significantly different from 0.2 in the subgroup.

Sensitivity for malignancy of SOC and sensitivity for malignancy of SOC + M-CT will be estimated, considering final pathology as the gold standard test.

Anatomic and procedural characteristics that are associated with navigational and diagnostic yield will be evaluated by multivariate logistic regression models. A p-value of less than 0.05 will indicate a statistical significance.

Will be summarized by mean (standard deviation \[SD\]) or median (interquartile range \[IQR\]).

Will be summarized by mean (SD) or median (IQR).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction	NCT06306638	Malignant Solid...	Biospecimen Col... Computed Tomogr... Endobronchial U... Interstitial Ph... Palliative Radi... Physical Perfor... Questionnaire A... Verteporfin	18 Years -	Roswell Park Cancer Institute
Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction	NCT06306638	Malignant Solid...	Biospecimen Col... Computed Tomogr... Endobronchial U... Interstitial Ph... Palliative Radi... Physical Perfor... Questionnaire A... Verteporfin	18 Years -	Roswell Park Cancer Institute
Feasibility of Mobile-CT-Assisted Bronchoscopy for the Diagnosis of Lung Lesion	NCT04995172	Lung Neoplasm	Computed Tomogr... Electronic Heal... Endobronchial U...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for endobronchial ultrasound bronchoscopy