Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002964
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
1999-11-01
Brief Title:
Porfimer Sodium in Diagnosing Patients With Head and Neck Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Pilot Study for the Diagnosis of Head and Neck Cancer Photofrin and Visible Light
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RPCI-DS-94-10 | None | None | None |
| NCI-V97-1196 | None | None | None |