Overview

This trial is active, not recruiting.

Conditions barrett's esophagus, high grade dysplasia
Treatments photodynamic therapy, radiofrequency ablation of barrett's esophagus
Phase phase 2/phase 3
Sponsor Mayo Clinic
Collaborator National Institutes of Health (NIH)
Start date December 2002
End date September 2012
Trial size 208 participants
Trial identifier NCT00587600, 2138-00, CA97048-05

Summary

This study is being done to find out if Photodynamic Therapy (treatment with a red light and a drug called photofrin) or Radiofrequency ablation works the same for patients who have biomarkers (abnormalities in molecules of cells that may or may not help predict cancer) present in their Barrett's esophagus as for patients who do not have biomarkers.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
will have photodynamic therapy
photodynamic therapy
Photofrin 2mg/kg Photoradiation The light dose delivered will be a total of 200 joules per centimeter fiber which has previously been shown to ablate Barrett's mucosa.
(Active Comparator)
radiofrequency ablation of barretts esophagus
radiofrequency ablation of barrett's esophagus
radiofrequency ablation

Primary Outcomes

Measure
The primary assessment for our first specific aim will be to determine the effect of photodynamic therapy on biomarkers after photodynamic therapy.
time frame: 12 months

Secondary Outcomes

Measure
The primary assessment for our second specific aim will be to assess if specific biomarkers can be correlated with the confirmed histological elimination of their Barrett's esophagus.
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

Inclusion Criteria: - All patients will have biopsy proven Barrett's esophagus with evidence of specialized intestinal epithelium and dysplasia (either high grade dysplasia or low grade dysplasia) on histology. - Patients must have endoscopically visible segments of Barrett's esophagus of greater than 1 centimeter in length. - All patients must be eligible for longterm follow-up as well as tolerate endoscopy, biopsy, and cytology. - Patients must be willing to travel to Rochester, Minnesota for follow-up - Patients must have a friend or relative accompany them on visits since sedatives will render them unable to operate a motor vehicle - If patients are on anticoagulation, they must be able to tolerate reversal of anticoagulation for study biopsies and therapy - All patients must be able to tolerate proton pump inhibitor therapy. Esomeprazole will be provided but can be changed to another proton pump inhibitor if the patient is intolerant. - All patients who have histological or cytological evidence of high grade dysplasia will be seen by an experienced thoracic surgeon for consideration of esophagectomy. Exclusion Criteria: - Patients who are unable to follow light avoidance instructions - Patients with a history of prior esophageal surgery or successful fundoplication - Patients who had prior photodynamic therapy - Patients with pre-existing strictures in their esophagus - Patients who have known allergies to porphyrin compounds - Patients with a prior biopsies of Barrett's esophagus that contain carcinoma - Patients who require continuous anti-coagulation - Patients who are pregnant or are capable of pregnancy will be excluded from this study unless they have been on effective birth control measures - Lactating mothers are excluded from this study as it is unclear whether the photosensitizer sodium porfimer can cross to the feeding infant - Patients with underlying liver disease are excluded since their metabolism of porphyrin based photosensitizers is uncertain. Evidence of liver disease will be an transaminase elevation of three times normal, a bilirubin increase of twice normal, or an alkaline phosphatase (liver fraction) elevation of twice normal. - Patients who have underlying medical conditions that are felt to limit their survival to less than one year.

Additional Information

Official title Biomarkers in Phototherapy of Barrett's Esophagus
Principal investigator Kenneth K Wang, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Mayo Clinic.