Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-05 @ 5:25 AM
Study NCT ID:
NCT01447134
Status:
UNKNOWN
Last Update Posted:
2011-10-06
First Post:
2011-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RGD-K5 in Head and Neck Cancer Patients
Sponsor:
Chang Gung Memorial Hospital
Organization:
Study Overview
Official Title:
Phase II Study of [18F]RGD-K5 in Head and Neck Cancer Patients
Status:
UNKNOWN
Status Verified Date:
2011-10
Last Known Status:
ENROLLING_BY_INVITATION
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:
1. Primary endpoint(s): To determine the relationship between the drug distribution and angiogenesis in head and neck cancer patients.
2. Secondary endpoint(s): To expand the safety database of \[F-18\]RGD-K5 and to correlate the parameters from the image study to clinical treatment response and prognosis.
2. Secondary endpoint(s): To expand the safety database of \[F-18\]RGD-K5 and to correlate the parameters from the image study to clinical treatment response and prognosis.
Detailed Description:
This is an uncontrolled, open-labeled, non-randomized, prospective study. The study duration is expected to be completed in a period of 3 year. Up to 100 patients would be included. Group A would be those to undergo surgical excision or biopsy (n=20); Group B would be those with N2c-3M0 disease to receive chemotherapy followed by concurrent chemoradiotherapy (n=40); and Group C would be those with M1 disease to receive biotherapy or chemotherapy (n=40). Group A patients could be included into Group B or C if qualified. Each participant must fulfill all the inclusion and exclusion criteria.
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?: