Biomarkers in Phototherapy of Barrett's Esophagus (BIOBAR)
This study is ongoing, but not recruiting participants.
Sponsor:
Mayo Clinic
Collaborator:
Information provided by (Responsible Party):
Kenneth K. Wang, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587600
First received: December 21, 2007
Last updated: May 8, 2013
Last verified: May 2013
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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 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 ]
| Enrollment: | 208 |
| Study Start Date: | December 2002 |
| Estimated Study Completion Date: | September 2013 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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 More Information
No publications provided
| Responsible Party: | Kenneth K. Wang, MD, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00587600 History of Changes |
| Other Study ID Numbers: | 2138-00, CA97048-05 |
| Study First Received: | December 21, 2007 |
| Last Updated: | May 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on May 22, 2013