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Clinical Application of 18F-FLT PET in Lung Tumors


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18 Years
90 Years
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Clinical Application of 18F-FLT PET in Lung Tumors


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.


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)

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Ruoh-Fang Yen, M.D PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Taiwan University Hospital

Authority:

Taiwan: Department of Health

Study ID:

200712071R

NCT ID:

NCT01089894

Start Date:

August 2008

Completion Date:

July 2011

Related Keywords:

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

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