Safety of Photodynamic Therapy (PDT) in the Ablation of High-grade Dysplasia (HGD) in Barrett's Esophagus (BE) (Oedisse)
Photodynamic therapy (PDT) uses a combination of a drug, porfimer sodium, and a light from a non heated laser. The activation of the drug is done by lighting of abnormal areas using a fiber optic device. The fiber optic device is a very fine fiber (like a fishing line) that permits transmission of light. The fiber optic device is inserted into a diffusing balloon device to ensure the good positioning of the fiber optic within the esophagus (food pipe). It is thought that the size and the flexibility of a new diffusing balloon device could improve the safety profile of the photodynamic treatment by reducing the risk of narrowing or closure of the food pipe (esophageal stenosis) sometimes occurring after treatment.
This research study will evaluate the safety and effectiveness of PDT with porfimer sodium using a new diffusing balloon device for light application in the removal of high-grade dysplasia (HGD, precancerous change in the food pipe tissue) in Barrett's esophagus (BE). This study will provide advanced knowledge about phototoxicity (reaction similar to sunburn) and esophageal stenosis, main risks with this therapy. It will involve 75 patients with HGD in BE across North America and Europe and will last between 13 and 16 weeks. In addition, concentrations of porfimer sodium in the esophageal tissue will be analyzed in a subgroup of patients.
Device: Medlight PDT Balloon
Procedure: Endoscopy with biopsy
Procedure: Chest x-ray
Procedure: Blood collection
Procedure: Tissue sample collection
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter, Prospective, Open-label, Single-arm Phase IIIb/IV Clinical Study on the Safety of Photodynamic Therapy With Porfimer Sodium for Injection for the Ablation of High-grade Dysplasia in Barrett's Esophagus|
- Incidence of phototoxicity reaction [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Incidence of esophageal stenosis [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Proportion of patients with complete ablation (removal) of high-grade dysplasia [ Time Frame: 3 months ] [ Designated as safety issue: No ]Complete ablation of high-grade dysplasia (pre-cancerous tissue) will be evaluated by biopsy
- Proportion of patients with adverse events as a measure of safety [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Measure oligomer concentrations [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Experimental: Medlight PDT Balloon||
Device: Medlight PDT Balloon
Medlight PDT Balloon will be used once to apply the laser light treatmentProcedure: Endoscopy
Endoscopy will be performed to confirm eligibility, apply photodynamic therapy, assess esophageal condition and effectiveness of the therapyProcedure: Endoscopy with biopsy
Endoscopy with collection of esophageal tissue will be performed at screening to confirm eligibility and at Week 13 (final visit) to assess effectivenessProcedure: Electrocardiogram
Resting electrocardiogram will be performed at screening (unless one has been performed within 30 days prior to screening) to measure heart functionProcedure: Chest x-ray
A chest X-ray will be performed at screening (unless one has been performed within 90 days prior to screening) to provide several pictures of the chest to rule out any lung abnormalitiesProcedure: Blood collection
Blood samples for laboratory tests will be taken to assess the overall conditionProcedure: Tissue sample collection
Esophageal tissue samples will be collected before the porfimer sodium injection and on four separate occasions after the injection (22-26 hour-, 40-50 hour-, 96-120 hour-intervals, and 13 weeks) to measure concentrations of oligomers in a subgroup of 12 patients.
Patients with biopsy-confirmed HGD in BE will be evaluated to confirm eligibility. Prior to enrollment, all inclusion and exclusion criteria will be verified. Medical procedures including demographic information, medical/surgical history, concurrent medical conditions, physical exam (including vital signs, body weight, height, and skin color), degree of difficulty in swallowing; electrocardiogram, chest X-ray, clinical laboratory testing, concomitant medication intake and other therapy uses will be collected.
All patients will receive one course of PDT consisting of an intravenous injection of 2.0 mg/kg of porfimer sodium over 3-5 minutes followed by one or two endoscopic laser light applications. The first laser light application will be performed within 40-50 hours using a new diffusing balloon catheter. The second laser light application (without a diffusing balloon catheter) will be performed within 96-120 hours on those areas showing an insufficient response to the first application. Follow-ups (Weeks 4 and 13) will include some or all of the following procedures: physical exam; vital signs evaluation; body weight; endoscopy; skin, degree of difficulty in swallowing and esophageal stenosis assessment; and clinical laboratory check. All patients will be asked general open questions about any occurrence of adverse events, change in concurrent medical conditions, use of adjunctive therapy/procedure, and intake of concomitant medication. All patients will undergo rigorous systematic endoscopic biopsy surveillance at Week 13 (final visit).
Tissue concentration of oligomers (component of porfimer sodium) in normal and abnormal esophageal tissues will be determined in a subgroup of 12 patients. These patients will provide esophageal tissue samples before the porfimer sodium injection and on four separate occasions after the injection (22-26 hour-, 40-50 hour-, 96-120 hour-intervals, and 13 weeks).
All patients will be followed for three months.
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