Biomarkers in Phototherapy of Barrett's Esophagus

NCT00587600 | Completed Phase 2 DMC

• 2 other identifiers: 2138-00CA97048-05
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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.

  12 months

Study Arms (2)

Photodynamic therapy

ACTIVE COMPARATOR

will have photodynamic therapy

Procedure: Photodynamic therapy

radiofrequency ablation of barretts esophagus

ACTIVE COMPARATOR

radiofrequency ablation of barretts esophagus

Procedure: radiofrequency ablation of barrett's esophagus

Interventions

Photodynamic therapy 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.

Photodynamic therapy

radiofrequency ablation of barrett's esophagus PROCEDURE

radiofrequency ablation

radiofrequency ablation of barretts esophagus

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Kenneth K Wang, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: December 1, 2002
• Primary Completion: April 21, 2017
• Study Completion: April 21, 2017
• Last Updated: November 22, 2017

Record last verified: 2017-11

Locations

US (1)