Biomarkers in Phototherapy of Barrett's Esophagus

NCT ID: NCT00587600

Last Updated: 2017-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31
• Study Completion Date: 2017-04-21

Brief 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.

Conditions

Barrett's Esophagus; High Grade Dysplasia

Keywords

Barrett's Esophagus; High Grade Dysplasia; Photodynamic Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Photodynamic therapy

will have photodynamic therapy

Group Type: ACTIVE_COMPARATOR

Photodynamic therapy

Intervention Type: PROCEDURE

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.

radiofrequency ablation of barretts esophagus

radiofrequency ablation of barretts esophagus

Group Type: ACTIVE_COMPARATOR

radiofrequency ablation of barrett's esophagus

Intervention Type: PROCEDURE

radiofrequency ablation

Interventions

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.

Intervention Type: PROCEDURE

radiofrequency ablation of barrett's esophagus

radiofrequency ablation

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Kenneth K. Wang

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth K Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

CA97048-05

Identifier Type: -

Identifier Source: secondary_id

2138-00

Identifier Type: -

Identifier Source: org_study_id