WithdrawnPhase 3

Safety of Photodynamic Therapy (PDT) in the Ablation of High-grade Dysplasia (HGD) in Barrett's Esophagus (BE)

Stopped: Sponsor cancelled the study

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients are males or females aged 18 or older. * Patients have been diagnosed with biopsy-proven HGD in BE. * Non-menopausal or non-surgically sterilized female patients must have a negative serum beta-HCG at the time of entry into the study. * Non-menopausal or non-surgically sterilized female patients must use a medically acceptable form of birth control. * Patients must sign an Informed Consent Form, which must comply with the ICH guidelines and local requirements. Exclusion Criteria: * Patients who have previously received PDT for HGD in BE. * Patients who have previously undergone radiation therapy to the chest. * Patients with known porphyria or known hypersensitivity to porphyrins or any excipients of the porfimer sodium. * Patients who have esophageal cancer or in whom esophageal cancer, lymph node involvement, or metastases cannot be ruled out based on the pathology report, endoscopic ultrasonography (EUS), computed tomography (CT) scan or other diagnostic methods used in current practice no more than 30 days prior to date of consent. * Patients with any acute or chronic medical or psychological illnesses as judged clinically significant by the investigator to preclude PDT procedure. * Patients with a presence or history of neoplasms (treated during the last five years prior to study entry) other than carcinoma in situ of the cervix or basal carcinoma of the skin. * Patients with esophageal strictures, esophageal diverticula, esophageal or g…

What they're measuring

Incidence of phototoxicity reaction

Timeframe: 3 months

Incidence of esophageal stenosis

Timeframe: 3 months

Trial details

NCT IDNCT01209013

SponsorPinnacle Biologics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL