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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01089894
First received: March 17, 2010
Last updated: March 18, 2010
Last verified: March 2010
History of Changes
  Purpose

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. 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. 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. To correlate 18F-FLT uptake with EGFR mutation status, therapeutic response and survival for NSCLC patients.

Condition
Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Application of 18F-FLT PET in Lung Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 90
Study Start Date: August 2008
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.)

Detailed Description:

Lung cancer has become a leading cause of cancer death in Taiwan. 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) using has been found to be effective in diagnosing, staging, and restaging primary non-small cell lung cancer (NSCLC). However, 18F-FDG is not tumor specific. It may also show increased uptake in benign tumors and tissue with inflammatory cells, such as macrophages and fibroblast. Therefore, the ability of 18F-FDG PET for characterizing lung nodule remains a challenge, especially in Taiwan where tuberculosis is still prevalent.

Recently, 18F-3'-fluoro-3'-deoxy-L-thymidine (18F-FLT), a radiolabeled analog of thymidine, has been synthesized for imaging tumor cell proliferation in vivo. The tracer is 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 dependent on the presence of TK-1 and therefore is closely associated with cellular proliferation. Malignant lung lesions revealed significant 18F-FLT accumulation while benign lung tumors showed no 18F-FLT uptake. Therefore, 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.

In the meantime, the cyclotron and hot lab facility in National Taiwan University Hospital (NTUH) has developed 18F-FLT successfully. After careful quality assurance and animal experiments, it is now ready to perform clinical studies on human beings.

We thus design this prospective 3-year project

  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. 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. To correlate 18F-FLT uptake with EGFR mutation status, therapeutic response and survival for NSCLC patients.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)

Criteria

Inclusion Criteria:

18F-FLT 1:

  1. indeterminate pulmonary nodule(s)
  2. has been scheduled an 18F-FDG PET for characterization of their indeterminate pulmonary nodule(s)
  3. consent to perform an additional 18F-FLT PET
  4. will receive biopsy or surgery for the pulmonary nodule(s)

18F-FLT 2:

  1. has pathological proved NSCLC
  2. is staged as inoperable advanced NSCLC
  3. has been scheduled to receive platinum-based chemotherapy
  4. 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

18F-FLT 3:

  1. has pathological proved NSCLC
  2. is staged as inoperable advanced NSCLC
  3. has been scheduled to receive EGFR tyrosine kinase inhibitor therapy
  4. consents to received 18F-FLT PET studies before, at the 2nd day or at the 7th day of therapy
  5. consents to undergo EGFR mutation analysis

Exclusion Criteria:

  1. Patients with other known malignancies
  2. Age under 18 years
  3. Hematological parameters: WBC < 3000/L or platelet < 75,000/L (WHO toxicity criteria of grade 1)
  4. Abnormal liver function: AST or ALT > 78U/L (WHO toxicity criteria of grade 1)
  5. Renal function: Creatinine > 2.0 mg/dl (WHO toxicity criteria of grade 1)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089894

Contacts
Contact: Ruoh-Fang Yen, M.D., Ph.D. 886-2-23123456 ext 65581 rfyen@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10043
Contact: Ruoh-Fang Yen, M.D., Ph.D.     886-2-23123456 ext 65581     rfyen@ntu.edu.tw    
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Ruoh-Fang Yen, M.D PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Yen RF, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01089894     History of Changes
Other Study ID Numbers: 200712071R
Study First Received: March 17, 2010
Last Updated: March 18, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
18F-FLT
PET
non-small cell lung cancer
 cell proliferation
therapeutic response
18F-3'-fluoro-3'-deoxy-L-thymidine (18F-FLT)

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Alovudine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013