NCT00002964

Porfimer Sodium in Diagnosing Patients With Head and Neck Cancer

Pilot Study for the Diagnosis of Head and Neck Cancer: Photofrin and Visible Light

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs that make cancer cells more visible to light may help in the diagnosis of head and neck cancer. PURPOSE: Phase II trial to study the usefulness of porfimer sodium in diagnosing patients with head and neck cancer.

Detailed description

OBJECTIVES: I. Determine whether porfimer sodium fluorescence can be used to reveal early malignant changes in patients with lesions of the oral cavity. II. Investigate whether porfimer sodium fluorescence can define areas of field cancerization in the oral mucosa, specifically satellite foci of malignant cells within the margins of an excision. III. Determine whether uptake of fluorescence is indicative of disease stage. OUTLINE: Patients receive porfimer sodium IV bolus and are kept in subdued light until examination with a fluorescence photometer 48 hours later. Patients must avoid sunlight and other intense lights for an additional 30 days. PROJECTED ACCRUAL: 20 patients will be accrued per year.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	porfimer sodium
OTHER	fluorophotometry

Timeline

• Start date: 1995-02-01
• Primary completion: 2004-04-01
• First posted: 2004-04-27
• Last updated: 2013-02-05

Locations

1 site across 1 country: United States