CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 10 enrolled
Drug / intervention
Porfimer Sodium +1 moredrug
Likely dose
Porfimer Sodium 2 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03344861
NCT03344861Phase 1Completed
CompareCT.gov

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

Concordia Laboratories Inc.·interventional·Posted Nov 17, 2017·Updated Jan 13, 2020

In Brief

A Phase 1 clinical trial evaluating Porfimer Sodium and Fiber optic for Lung Cancer and Lung Cancer Metastatic. Completed, enrolled 10 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer, Lung Cancer Metastatic
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedNov 17, 2017
Enrollment StartAug 14, 2017
Primary CompletionMar 22, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.6 years ago

Interventions

Porfimer Sodiumdrug

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.