Biomarkers in Phototherapy of Barrett's Esophagus

Barrett's Esophagus Clinical Trial

— BIOBAR  

Official title:

Biomarkers in Phototherapy of Barrett's Esophagus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00587600
• Other study ID #: 2138-00
• Secondary ID: CA97048-05
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 21, 2007
• Last updated: November 20, 2017
• Start date: December 2002
• Est. completion date: April 21, 2017

Study information

• Verified date: November 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: April 21, 2017
• Est. primary completion date: April 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus
• High Grade Dysplasia

Intervention

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.
• radiofrequency ablation of barrett's esophagus
radiofrequency ablation

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary assessment for our first specific aim will be to determine the effect of photodynamic therapy on biomarkers after photodynamic therapy.		12 months
Secondary	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.		12 months