Completed

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

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What is being tested

porfimer sodium

+ fluorophotometry

DrugOther
Who is being recruted

Laryngeal Diseases+13

+ Stomatognathic Diseases

+ Mouth Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Diagnostic Study

Phase 2
Interventional
Study Start: February 1995
See protocol details

Summary

Principal SponsorRoswell Park Cancer Institute
Last updated: February 5, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 1995

Actual date on which the first participant was enrolled.

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.

NCT00002964
Principal SponsorRoswell Park Cancer Institute
Last updated: February 5, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Laryngeal DiseasesStomatognathic DiseasesMouth DiseasesNeoplasmsNeoplasms by SiteOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsPharyngeal DiseasesPharyngeal NeoplasmsRespiratory Tract DiseasesRespiratory Tract NeoplasmsHead and Neck NeoplasmsHypopharyngeal NeoplasmsLaryngeal NeoplasmsMouth NeoplasmsOropharyngeal Neoplasms

Criteria

DISEASE CHARACTERISTICS: Malignant or suspected lesions of the head and neck that are scheduled for excisional biopsy Lesions no greater than 2 cm in diameter in the mouth, oropharynx, hypopharynx or larynx Suspected severe dysplasia, carcinoma in situ and/or invasive carcinoma of the head and neck PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC greater than 3500/mm3 Platelet count greater than 100,000/mm3 Hepatic: SGOT and SGPT no greater than 2 times upper limit of normal Alkaline phosphatase no greater than 2 times upper limit of normal Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2.5 mg/dL Other: No known hypersensitivity to porphyrins Not pregnant Fertile patients must use effective birth control PRIOR CONCURRENT THERAPY: Not specified

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Roswell Park Cancer Institute

Buffalo, United StatesOpen Roswell Park Cancer Institute in Google Maps
CompletedOne Study Center