Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-03-01 @ 12:05 PM
Study NCT ID:
NCT01886235
Status:
COMPLETED
Last Update Posted:
2020-08-07
First Post:
2013-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intravital Microscopy for Identifying Tumor Vessels in Patients With Stage IA-IV Melanoma That is Being Removed by Surgery
Sponsor:
Roswell Park Cancer Institute
Organization:
Study Overview
Official Title:
A Pilot Study of Feasibility of Performing Intravital Microscopy in Melanoma Patients
Status:
COMPLETED
Status Verified Date:
2020-07
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:
This pilot clinical trial studies intravital microscopy for identifying tumor vessels in patients with stage IA-IV melanoma that is being removed by surgery. New imaging procedures, such as intravital microscopy, may determine the extent of melanoma.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the feasibility of performing intravital microscopy on accessible human melanoma tumors during their standard course of treatment (i.e., wide local excision). (Part I)
SECONDARY OBJECTIVES:
I. To determine the blood flow velocity of the tumor vessels and tissue penetration of fluorescein (fluorescein sodium) as a marker of tumor vessel permeability. (Part II)
OUTLINE:
Patients receive fluorescein sodium intravenously (IV) followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.
After completion of study treatment, patients are followed up at 3 weeks and then periodically for 5 years.
I. To determine the feasibility of performing intravital microscopy on accessible human melanoma tumors during their standard course of treatment (i.e., wide local excision). (Part I)
SECONDARY OBJECTIVES:
I. To determine the blood flow velocity of the tumor vessels and tissue penetration of fluorescein (fluorescein sodium) as a marker of tumor vessel permeability. (Part II)
OUTLINE:
Patients receive fluorescein sodium intravenously (IV) followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.
After completion of study treatment, patients are followed up at 3 weeks and then periodically for 5 years.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2013-01052 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| I 231512 | OTHER | Roswell Park Cancer Institute | View | |
| P30CA016056 | NIH | None | https://reporter.nih.gov/quic… | View |