Viewing Study NCT00304694


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Study NCT ID: NCT00304694
Status: UNKNOWN
Last Update Posted: 2006-03-20
First Post: 2006-03-16
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Whole-Body 18F-FDG PET in Induction Chemotherapeutic Response for Advanced NPC Patients
Sponsor: National Taiwan University Hospital
Organization:

Study Overview

Official Title: Whole-Body 18F-FDG PET in Evaluating Induction Chemotherapeutic Response for Locally Advanced Nasopharyngeal Cancer Patients and Correlating With Histopathology: a Prospective Study
Status: UNKNOWN
Status Verified Date: 2006-03
Last Known Status: RECRUITING
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: 18F-FDG PET, a whole-body imaging technology based on glucose metabolism, can effectively detect subclinical and clinical therapeutic responses at stages that are earlier than those detected by conventional approaches.

We propose to conduct a prospective study to evaluate therapeutic response using 18F-FDG PET before and after induction chemotherapy for locally advanced NPC patients.
Detailed Description: In order to improve locoregional control and to eradicate micrometastases for patients with locally advanced nasopharyngeal carcinoma (NPC), induction chemotherapy followed by concurrent chemoradiotherapy has been the preferred therapeutic approach.Although it would be of great advantage to identify non-responder during or immediately after therapy to formulate an alternative treatment strategy, non-invasive methods for early evaluation of therapeutic response for advanced NPC patients have not been fully evaluated. Decrease of tumor volume in anatomical images and relief of symptoms in clinical follow-up have been used in many conventional approaches to evaluate the effectiveness of therapy. However, an effective therapy could very well have resulted in early subclinical alterations in tumor physiology and biochemistry. These alterations may have occurred long before changes in the tumor mass become apparent. Thus therapeutic effect may not be assessed accurately using the conventional anatomical imaging studies, such as CT and MRI.Recent studies have shown that 18F-FDG PET, a whole-body imaging technology based on glucose metabolism, can effectively detect subclinical and clinical therapeutic responses at stages that are earlier than those detected by conventional approaches.We therefore propose to conduct a prospective study to evaluate therapeutic response using 18F-FDG PET before and after induction chemotherapy for locally advanced NPC patients.

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: