Biomarkers in Phototherapy of Barrett's Esophagus - Full Text View

Sponsor:	Mayo Clinic
Collaborator:	National Institutes of Health (NIH)
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00587600

Purpose

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	Intervention	Phase
Barrett's Esophagus High Grade Dysplasia	Procedure: Photodynamic therapy Procedure: radiofrequency ablation of barrett's esophagus	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Biomarkers in Phototherapy of Barrett's Esophagus

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	210
Study Start Date:	December 2002
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: No Intervention radiofrequency ablation of barretts esophagus	Procedure: radiofrequency ablation of barrett's esophagus radiofrequency ablation

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587600

Contacts

Contact: Kenneth K Wang, MD	507-255-7495	barretts@mayo.edu
Contact: Lori S Lutzke	507-255-7495	lutzke.lori@mayo.edu

Locations

United States, Minnesota
Mayo Clinic Rochester	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Lori S Lutzke, LPNCCRP 507-255-7495 lutzke.lori@mayo.edu
Principal Investigator: Kenneth K Wang, MD

Sponsors and Collaborators

Mayo Clinic

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Kenneth K Wang, MD

Mayo Clinic

More Information

No publications provided

Responsible Party:	Mayo Clinic ( Kenneth K Wang MD )
Study ID Numbers:	2138-00, CA97048-05
Study First Received:	December 21, 2007
Last Updated:	September 14, 2009
ClinicalTrials.gov Identifier:	NCT00587600 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

Barrett's Esophagus
High Grade Dysplasia
Photodynamic Therapy

Additional relevant MeSH terms:

Digestive System Diseases
Digestive System Abnormalities
Gastrointestinal Diseases
Barrett Esophagus
Esophageal Diseases

ClinicalTrials.gov processed this record on February 08, 2010