SarcoidosisNCT00369980
Diagnostic Usefulness of Fluorine-18-α-Methyltyrosine PET in Combination With 18F-FDG in Sarcoidosis Patient
An observational study of Sarcoidosis, run by Gunma University at 1 site in Japan.
Trial summary
L-[3-18F]-α-methyltyrosine (FMT) is amino-acid tracer for positron emission tomography (PET), and is used for tumor detection because malignant tumor cells accumulate 18F-FMT based on the increased expression of amino-acid transporter. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoidosis
- How many people
- Not given
- Where
- 1 siteJapan
- Study dates
- Sep 1998to Aug 2005
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Eligible patients were required to have histologically proven noncaseating epithelioid cell granuloma and at least one disease that the possibility of coexistent malignancy could not be excluded as follows; 1) extrapulmonary lesions mimicking malignant diseases including systemic lymphadenopathy, hepatosplenic involvement, or other lesions, 2) multiple nodular lesions mimicking pulmonary metastasis, 3) the occurrence of BHL in cancer patient.
Who cannot join
- The patients that PET imaging using 18F-FDG and 18F-FMT was performed before establishment of the final diagnosis of sarcoidosis, patients undergoing treatment for sarcoidosis before the PET study, and patient having diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
About this study
L-[3-18F]-α-methyltyrosine (FMT) is amino-acid tracer for positron emission tomography (PET), and is used for tumor detection because malignant tumor cells accumulate 18F-FMT based on the increased expression of amino-acid transporter. This study was conducted to investigate a usefulness of 18F-FMT PET in combination with 18F-FDG PET for the diagnosis of sarcoidosis in patients with suspected malignancy.
- Conditions
- Sarcoidosis
- Medical subject headings
- Sarcoidosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2006 (estimated)
- Study startSep 1998
- Study completionAug 2005
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 SarcoidosisStudies 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 University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369980
- Sponsor's protocol ID
- GunmaU
- Status last verified
- Aug 2005
- First submitted
- 29 Aug 2006
- Last updated
- 7 Nov 2006
- Results posted
- No
Publications
Kaira K, Oriuchi N, Otani Y, Yanagitani N, Sunaga N, Hisada T, Ishizuka T, Endo K, Mori M. Diagnostic usefulness of fluorine-18-alpha-methyltyrosine positron emission tomography in combination with 18F-fluorodeoxyglucose in sarcoidosis patients. Chest. 2007 Apr;131(4):1019-27. doi: 10.1378/chest.06-2160.
PubMed 17426205
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Usefulness of Fluorine-18-α-Methyltyrosine PET in Combination With 18F-FDG in Sarcoidosis Patient
- ClinicalTrials.gov ID
- NCT00369980
- Acronym / sponsor ID
- GunmaU
- Conditions
- Sarcoidosis
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Gunma UniversityUniversity, hospital or other
- Study start
- Sep 1998
- Study completion
- Aug 2005
- First posted
- 30 Aug 2006 (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.
L-[3-18F]-α-methyltyrosine (FMT) is amino-acid tracer for positron emission tomography (PET), and is used for tumor detection because malignant tumor cells accumulate 18F-FMT based on the increased expression of amino-acid transporter. This study was conducted to investigate a usefulness of 18F-FMT PET in combination with 18F-FDG PET for the diagnosis of sarcoidosis in patients with suspected malignancy.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible patients were required to have histologically proven noncaseating epithelioid cell granuloma and at least one disease that the possibility of coexistent malignancy could not be excluded as follows; 1) extrapulmonary lesions mimicking malignant diseases including systemic lymphadenopathy, hepatosplenic involvement, or other lesions, 2) multiple nodular lesions mimicking pulmonary metastasis, 3) the occurrence of BHL in cancer patient.
Key exclusion criteria (1 listed)
- The patients that PET imaging using 18F-FDG and 18F-FMT was performed before establishment of the final diagnosis of sarcoidosis, patients undergoing treatment for sarcoidosis before the PET study, and patient having 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 7 Nov 2006.
- Derived from this study: PubMed 17426205Kaira K, Oriuchi N, Otani Y, Yanagitani N, Sunaga N, Hisada T, Ishizuka T, Endo K, Mori M. Diagnostic usefulness of fluorine-18-alpha-methyltyrosine positron emission tomography in combination with 18F-fluorodeoxyglucose in sarcoidosis patients. Chest. 2007 Apr;131(4):1019-27. doi: 10.1378/chest.06-2160.
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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 University Graduate School of Medicine
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 Sarcoidosis, run by Gunma University at 1 site in Japan.
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 7 Nov 2006. 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 Japan. 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?
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 NCT00369980, 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 7 Nov 2006.