Whole-Body 18F-FDG PET in Induction Chemotherapeutic Response for Advanced NPC Patients

Nasopharyngeal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00304694
• Other study ID #: 940601
• Status: Recruiting
• Phase: N/A
• First received: March 16, 2006
• Last updated: March 16, 2006
• Start date: March 2006

Study information

• Verified date: March 2006
• Source: National Taiwan University Hospital
• Contact: Ruoh-Fang Yen, MD, PhD
• Phone: 886-2-23123456
• Email: rfyen[@]ha.mc.ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• newly diagnosed locally advanced NPC patients who are receiving induction chemotherapy for treatment

Exclusion Criteria:

• age below 18 year old

• pregnancy women

Study Design

Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Nasopharyngeal Cancer
• Nasopharyngeal Neoplasms

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan,