Biomarkers in Phototherapy of Barrett's Esophagus (BIOBAR)

November 20, 2017 updated by: Kenneth K. Wang, Mayo Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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
Procedure: radiofrequency ablation of barrett's esophagus
radiofrequency ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (ACTUAL)

April 21, 2017

Study Completion (ACTUAL)

April 21, 2017

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

January 4, 2008

First Posted (ESTIMATE)

January 7, 2008

Study Record Updates

Last Update Posted (ACTUAL)

November 22, 2017

Last Update Submitted That Met QC Criteria

November 20, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2138-00
  • CA97048-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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