Breast NeoplasmsNCT01713049
18F-FLT PET for Suspicious Findings on Mammography and Breast Ultrasound
A study testing 18F-FLT in people with Breast Neoplasms, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose: To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions on mammograms and ultrasound. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- 18F-FLT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2010to Dec 2013
- Phase
- Interventional
- 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 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged between 20 to 80 years
- women who have localized findings on mammography and / or ultrasound and will receive biopsy.
- The lesions on the conventional imaging measure >=1cm
- WBC count >=3000/L, or platelet>=75,000/L
- Liver function, AST or ALT < 78 U/L
- Renal function, Creatinine < 2.0 mg/dl.The laboratory examinations should be performed within 4months before our study.
Who cannot join
- Pregnant women or who are planning to be pregnant.
- Known cancers in other organs.
- Women who are not able to cooperate with the PET/CT examination.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Medical Imaging NTUH
Taipei, 100
Jane Wang, MD, PhD, +886-2-23123456 ext. 65565, hstjen@yahoo.com.tw
About this study
Official title: Use of 18F-FLT Positron Emission Tomography to Evaluate the Suspicious Findings on Mammography and Breast Ultrasound: A Pilot Study
The purpose: To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions on mammograms and ultrasound.
Read the detailed description
- To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions on mammograms and ultrasound, using the pathologic result of biopsy as gold standard, and to determine whether 18F-FLT PET can increase the specificity in breast lesion diagnosis and thus reduce the unnecessary biopsy.
- To evaluate whether 18F-FLT PET is a cost-effective imaging modality for breast cancer diagnosis.
- Conditions
- Breast Neoplasms
- Being tested
- 18F-FLT
- Keywords
- FLT PET, breast neoplasms, mammography, breast ultrasound
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FLTDrug
Also called FLT
0.07 mCi/kg of 18F-FDG will be injected intravenously. The data acquisition will be started at 90 minutes after the injection using 2-D acquisition from a GE DISCOVERY ST PET/CT scanner (GE Medical Systems, Milwaukee, WI).
| Study group | Role | What they receive |
|---|---|---|
| 18F-FLT | Other | 18F-FLT PET for Suspicious Findings on Mammography and Breast Ultrasound. Receives: Drug: 18F-FLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions on mammograms and ultrasound, using the pathologic result of biopsy as gold standard.
Measured: The biopsy procedures will be scheduled as soon as possible and should be finished within 2 months after 18F-FLT PET.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startAug 2010
- Primary completionDec 2012 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
- Investigators
- Jane Wang, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713049
- Sponsor's protocol ID
- 201001043M
- Status last verified
- Aug 2010
- First submitted
- 21 Oct 2012
- Last updated
- 24 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of 18F-FLT Positron Emission Tomography to Evaluate the Suspicious Findings on Mammography and Breast Ultrasound: A Pilot Study
- ClinicalTrials.gov ID
- NCT01713049
- Acronym / sponsor ID
- 201001043M
- Conditions
- Breast Neoplasms
- Keywords
- FLT PET, breast neoplasms, mammography, breast ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 24 Oct 2012 (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 purpose: To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions on mammograms and ultrasound.
Detailed description
- To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions on mammograms and ultrasound, using the pathologic result of biopsy as gold standard, and to determine whether 18F-FLT PET can increase the specificity in breast lesion diagnosis and thus reduce the unnecessary biopsy.
- To evaluate whether 18F-FLT PET is a cost-effective imaging modality for breast cancer diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-FLT | Other | Drug: 18F-FLT18F-FLT PET for Suspicious Findings on Mammography and Breast Ultrasound. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women aged between 20 to 80 years
- women who have localized findings on mammography and / or ultrasound and will receive biopsy.
- The lesions on the conventional imaging measure >=1cm
- WBC count >=3000/L, or platelet>=75,000/L
- Liver function, AST or ALT < 78 U/L
Key exclusion criteria (3 listed)
- Pregnant women or who are planning to be pregnant.
- Known cancers in other organs.
- Women who are not able to cooperate with the PET/CT examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FLTAlso: FLT0.07 mCi/kg of 18F-FDG will be injected intravenously. The data acquisition will be started at 90 minutes after the injection using 2-D acquisition from a GE DISCOVERY ST PET/CT scanner (GE Medical Systems, Milwaukee, WI). | Drug | 18F-FLT |
Primary outcome
To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions on mammograms and ultrasound, using the pathologic result of biopsy as gold standard.
Time frame: The biopsy procedures will be scheduled as soon as possible and should be finished within 2 months after 18F-FLT PET.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2012.
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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.
Jane Wang, 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?
A study testing 18F-FLT in people with Breast Neoplasms, 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 6 inclusion and 3 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 24 Oct 2012. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions on mammograms and ultrasound, using the pathologic result of biopsy as gold standard. (time frame: The biopsy procedures will be scheduled as soon as possible and should be finished within 2 months after 18F-FLT PET.). It is what the study was designed to measure, not a finding.
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 24 Oct 2012.