Carcinoma, Non-Small-Cell LungNCT00464282
Fluorine-18-α-Methyltyrosine Positron Emission Tomography for Diagnosis and Staging of Lung Cancer
An observational study of Carcinoma, Non-Small-Cell Lung, run by Gunma University.
Trial summary
Objective: L-[3-18F]-α-methyltyrosine (FMT) is an amino-acid tracer for PET. We evaluated the diagnostic usefulness of 18F-FMT PET in non-small cell lung cancer (NSCLC) patients. Read more about this study
- Who is it for?
- Ages 8 months to 2 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 8 months to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- proven or suspected non-small cell lung cancer
Who cannot join
- uncontrolled diabetes mellitus
About this study
Objective: L-[3-18F]-α-methyltyrosine (FMT) is an amino-acid tracer for PET. We evaluated the diagnostic usefulness of 18F-FMT PET in non-small cell lung cancer (NSCLC) patients. Tumor uptake of 18F-FMT PET was compared with 18F-FDG PET and the correlation with L-type amino acid transporter 1 (LAT1) expression also investigated.
Method: Fifty patients with NSCLC were enrolled in this study, and a pair of PET study with 18F-FMT and 18F-FDG was performed. LAT1 expression and Ki-67 labeling index of the resected tumors were analyzed by immunohistochemical study.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Fluorine-18-α-methyltyrosine,, Positron emission tomography,, Fluorodeoxyglucose, Lung cancer,, Amino acid transportor 1,, Ki-67, Proven or suspected non-small cell lung cancer were enrolled in the study
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- 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
- Defined population
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Gunma University
- Sponsor type
- University, hospital or other
- Investigators
- kyoichi kaira, MD, Principal investigator, Gunma Unversity Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00464282
- Sponsor's protocol ID
- Gunma 444
- Status last verified
- Apr 2007
- First submitted
- 20 Apr 2007
- Last updated
- 23 Apr 2007
- Results posted
- No
Publications
Kaira K, Oriuchi N, Shimizu K, Tominaga H, Yanagitani N, Sunaga N, Ishizuka T, Kanai Y, Mori M, Endo K. 18F-FMT uptake seen within primary cancer on PET helps predict outcome of non-small cell lung cancer. J Nucl Med. 2009 Nov;50(11):1770-6. doi: 10.2967/jnumed.109.066837. Epub 2009 Oct 16.
PubMed 19837768
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorine-18-α-Methyltyrosine Positron Emission Tomography for Diagnosis and Staging of Lung Cancer
- ClinicalTrials.gov ID
- NCT00464282
- Acronym / sponsor ID
- Gunma 444
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Fluorine-18-α-methyltyrosine,, Positron emission tomography,, Fluorodeoxyglucose, Lung cancer,, Amino acid transportor 1,, Ki-67, Proven or suspected non-small cell lung cancer were enrolled in the study
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Gunma UniversityUniversity, hospital or other
- First posted
- 23 Apr 2007 (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.
Objective: L-[3-18F]-α-methyltyrosine (FMT) is an amino-acid tracer for PET. We evaluated the diagnostic usefulness of 18F-FMT PET in non-small cell lung cancer (NSCLC) patients. Tumor uptake of 18F-FMT PET was compared with 18F-FDG PET and the correlation with L-type amino acid transporter 1 (LAT1) expression also investigated.
Method: Fifty patients with NSCLC were enrolled in this study, and a pair of PET study with 18F-FMT and 18F-FDG was performed. LAT1 expression and Ki-67 labeling index of the resected tumors were analyzed by immunohistochemical study.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- proven or suspected non-small cell lung cancer
Key exclusion criteria (1 listed)
- uncontrolled diabetes mellitus
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2007.
- Derived from this study: PubMed 19837768Kaira K, Oriuchi N, Shimizu K, Tominaga H, Yanagitani N, Sunaga N, Ishizuka T, Kanai Y, Mori M, Endo K. 18F-FMT uptake seen within primary cancer on PET helps predict outcome of non-small cell lung cancer. J Nucl Med. 2009 Nov;50(11):1770-6. doi: 10.2967/jnumed.109.066837. Epub 2009 Oct 16.
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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.
kyoichi kaira, MD principal investigator
Gunma Unversity Graduate School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by Gunma University.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00464282, which also lists 1 linked publication.
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 23 Apr 2007.