Lung CancerNCT01089894
Clinical Application of 18F-3'-Fluoro-3'-Deoxy-L-thymidine (18F-FLT) Positron Emission Tomography (PET) in Lung Tumors
An observational study of Lung Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Cancer
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2008to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.)
Who may be able to join
- 18F-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)
- 18F-FLT 2:
Show all 16Show fewer
- 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
- 18F-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
- consents to undergo EGFR mutation analysis
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 10043
Ruoh-Fang Yen, M.D., Ph.D., 886-2-23123456 ext. 65581, rfyen@ntu.edu.tw
About this study
Official title: Clinical Application of 18F-FLT PET in Lung Tumors
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.
Read more
We thus design this prospective 3-year project
- 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.
- To assess the usefulness of 18F-FLT PET in early prediction of therapeutic response of platinum-based chemotherapies or EGFR inhibitors for NSCLC patients.
- To correlate 18F-FLT uptake with EGFR mutation status, therapeutic response and survival for NSCLC patients.
Read the 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
- 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.
- To assess the usefulness of 18F-FLT PET in early prediction of therapeutic response of platinum-based chemotherapies or EGFR inhibitors for NSCLC patients.
- 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)
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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.) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study startAug 2008
- Primary completionJul 2011 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ruoh-Fang Yen, M.D PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089894
- Sponsor's protocol ID
- 200712071R
- Status last verified
- Mar 2010
- First submitted
- 17 Mar 2010
- Last updated
- 19 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of 18F-FLT PET in Lung Tumors
- ClinicalTrials.gov ID
- NCT01089894
- Acronym / sponsor ID
- 200712071R
- 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 type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 19 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- To assess the usefulness of 18F-FLT PET in early prediction of therapeutic response of platinum-based chemotherapies or EGFR inhibitors for NSCLC patients.
- To correlate 18F-FLT uptake with EGFR mutation status, therapeutic response and survival for NSCLC patients.
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
- 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.
- To assess the usefulness of 18F-FLT PET in early prediction of therapeutic response of platinum-based chemotherapies or EGFR inhibitors for NSCLC patients.
- To correlate 18F-FLT uptake with EGFR mutation status, therapeutic response and survival for NSCLC patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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.) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.)
Key inclusion criteria (16 listed)
- 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)
- has pathological proved NSCLC
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruoh-Fang Yen, M.D PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruoh-Fang Yen, M.D., Ph.D. (886-2-23123456 ext. 65581, rfyen@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2010.