Clinical Application of 18F-3'-Fluoro-3'-Deoxy-L-thymidine (18F-FLT) Positron Emission Tomography (PET) in Lung Tumors

NCT01089894 | Unknown

• 1 other identifier: 200712071R
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The ability of 18F-FDG PET for characterizing lung nodule remains a challenge, especially in Taiwan where tuberculosis is still prevalent. 18F-3'-fluoro-3'-deoxy-L-thymidine (18F-FLT), a radiolabeled analog of thymidine, can be trapped within the cytosol after being monophosphorylated by thymidine kinase-1 (TK-1), a principle enzyme in the salvage pathway of DNA synthesis. It has been demonstrated in cell culture, animal models and clinical studies that the accumulation of 18F-FLT is closely associated with cellular proliferation. 18F-FLT PET may be more accurate than 18F-FDG PET in differentiating benign from malignant pulmonary lesions. In addition, the correlation between 18F-FLT uptake and cellular proliferation hints the usefulness of 18F-FLT PET for monitoring treatment response with cytostatic anticancer drugs. We thus design this prospective 3-year project

1. 1.To evaluate the usefulness of 18F-FLT PET and 18F-FDG PET in differentiating benign from malignant pulmonary nodules in Taiwan where tuberculosis is still prevalent.
2. 2.To assess the usefulness of 18F-FLT PET in early prediction of therapeutic response of platinum-based chemotherapies or EGFR inhibitors for NSCLC patients.
3. 3.To correlate 18F-FLT uptake with EGFR mutation status, therapeutic response and survival for NSCLC patients.

Conditions

Lung Cancer

Keywords

18F-FLT; PET; non-small cell lung cancer; cell proliferation; therapeutic response; 18F-3'-fluoro-3'-deoxy-L-thymidine (18F-FLT)

Study Arms (3)

18F-FLT 1

18F-FLT in differentiating benign from malignant pulmonary nodules

18F-FLT 2

18F-FLT in evaluating therapeutic response of platinum-based chemotherapy (The chemotherapeutic drugs used in the study are all approved by the Department of Health, Taiwan.)

18F-FLT 3

18F-FLT in evaluating therapeutic response of EGFR tyrosin kinase inhibitors (The target therapeutic drugs used in the study are all approved by the Department of Health, Taiwan.)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

18F-FLT 1: 18F-FLT in differentiating benign from malignant pulmonary nodules 18F-FLT 2: 18F-FLT in evaluating therapeutic response of platinum-based chemotherapy (The chemotherapeutic drugs used in the study are all approved by the Department of Health 18F-FLT 3: 18F-FLT in evaluating therapeutic response of EGFR tyrosin kinase inhibitors (The target therapeutic drugs used in the study are all approved by the Department of Health, Taiwan.)

You may qualify if:

• F-FLT 1:
• indeterminate pulmonary nodule(s)
• has been scheduled an 18F-FDG PET for characterization of their indeterminate pulmonary nodule(s)
• consent to perform an additional 18F-FLT PET
• will receive biopsy or surgery for the pulmonary nodule(s)
• F-FLT 2:
• has pathological proved NSCLC
• is staged as inoperable advanced NSCLC
• has been scheduled to receive platinum-based chemotherapy
• consents to received 18F-FLT PET studies before, at the day before initiation of 2nd cycle of therapy or at 7 days after completion of therapy
• F-FLT 3:
• has pathological proved NSCLC
• is staged as inoperable advanced NSCLC
• has been scheduled to receive EGFR tyrosine kinase inhibitor therapy
• consents to received 18F-FLT PET studies before, at the 2nd day or at the 7th day of therapy

You may not qualify if:

• Patients with other known malignancies
• Age under 18 years
• Hematological parameters: WBC \< 3000/L or platelet \< 75,000/L (WHO toxicity criteria of grade 1)
• Abnormal liver function: AST or ALT \> 78U/L (WHO toxicity criteria of grade 1)
• Renal function: Creatinine \> 2.0 mg/dl (WHO toxicity criteria of grade 1)

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 10043, Taiwan

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Hyperplasia

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ruoh-Fang Yen, M.D PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruoh-Fang Yen, M.D., Ph.D.

CONTACT

886-2-23123456; rfyen@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 19, 2010
• Study Start: August 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: March 19, 2010

Record last verified: 2010-03

Locations

TW (1)