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Biomarkers in Phototherapy of Barrett's Esophagus (BIOBAR)

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ClinicalTrials.gov Identifier: NCT00587600
Recruitment Status : Completed
First Posted : January 7, 2008
Last Update Posted : November 22, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Barrett's Esophagus High Grade Dysplasia Procedure: Photodynamic therapy Procedure: radiofrequency ablation of barrett's esophagus Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biomarkers in Phototherapy of Barrett's Esophagus
Study Start Date : December 2002
Primary Completion Date : April 21, 2017
Study Completion Date : April 21, 2017
Arms and Interventions

Arm Intervention/treatment
Active Comparator: Photodynamic therapy
will have photodynamic therapy
Procedure: 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 barretts esophagus
Procedure: radiofrequency ablation of barrett's esophagus
radiofrequency ablation

Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00587600

United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institutes of Health (NIH)
Principal Investigator: Kenneth K Wang, MD Mayo Clinic
More Information

Responsible Party: Kenneth K. Wang, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587600     History of Changes
Other Study ID Numbers: 2138-00
First Posted: January 7, 2008    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017

Keywords provided by Kenneth K. Wang, Mayo Clinic:
Barrett's Esophagus
High Grade Dysplasia
Photodynamic Therapy

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases