Breast CancerPhase 4NCT01956890
18F-FLT Positron Emission Tomography and Magnetic Resonance Imaging of the Breast
A Phase 4 study testing PET in people with Breast Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This prospective study is aimed to evaluate the diagnostic effectiveness of 18F-FLT PET in differentiating benign nature from malignancy for lesions with suspicious or ambiguous findings on mammography or ultrasound; to determine whether 18F-FLT PET or MRI can increase the specificity in breast lesion diagnosis and… Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2011to Mar 2016
- Phase
- Phase 4
- 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
- 1) Women aged between 20 to 80 years 2) women who have localized findings on mammography and / or ultrasound and will receive biopsy 3) The lesions on the conventional imaging measure >=1cm 4) WBC count >=3000/L, or platelet>=75,000/L 5) Liver function, AST or ALT <78 U/L 6) Renal function, Creatinine <2.0 mg/dl., and estimated GFR(eGFR)>60ml/min/1.73m2.
Who cannot join
- 1) Pregnant women or who are planning to be pregnant, or who are lactating. (Eligible women who are premenopausal with reproductive potential should receive urine pregnancy test before the MRI and PET. Women with a positive pregnancy test should be excluded from the study.) 2) Known cancers in other organs. 3) Women who are not able to cooperate with the PET/CT examination, or MRI examination.
- 4) Women≦19 years old. 5) Past history of severe anaphylactoid reaction to MRI-contrast agent or 18F-FLT.
- 6) History of mechanical valve replacement, recent coronary artery stent placement, with pacemaker, aneurysmal clip, metallic endotracheal tube, or other procedures with metallic device application.
- 7) eGFR≦60ml/min/1.73m2. 8) History of acute renal failure, or renal dialysis.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 100
Jane Wang, PhD, 886223123456 ext. 65565, hstjen@yahoo.com.tw
Jane Wang, PhD
About this study
Official title: Integrative Diagnosis of 18F-FLT Positron Emission Tomography and Magnetic Resonance Imaging to Evaluate the Suspicious Findings on Mammography and Breast Ultrasound: a Pilot Study
This prospective study is aimed to evaluate the diagnostic effectiveness of 18F-FLT PET in differentiating benign nature from malignancy for lesions with suspicious or ambiguous findings on mammography or ultrasound; to determine whether 18F-FLT PET or MRI can increase the specificity in breast lesion diagnosis and thus reduce the unnecessary biopsy, and which (18F-FLT PET or MRI) reveals the higher diagnostic performance.
Read the detailed description
It has been reported that PET (Positron Emission Tomography) scan is also useful in diagnosing breast cancer. 18F-fluorodeoxyglucose (18F-FDG), which based on glucose metabolism for the determination of malignancy, is the most popular PET tracer at present. However, 18F-FDG is not tumor specific. Benign inflammatory lesions may also demonstrate increase in 18F-FDG uptake. On the other hand, low grade malignancy may have low 18F-FDG concentration. Recently, 18F-3'-fluoro-3'-deoxy-L-thymidine (18F-FLT), a radiolabelled analog of thymidine, has been used in imaging cell proliferation and monitoring of treatment effects for breast cancer patients. 18F-FLT is believed to be more specific than 18F-FDG for breast cancer diagnosis and may provide the underlined physiological and molecular manifestations of breast lesions in addition to anatomical manifestations from mammography, ultrasound or MRI. Yet, its potential role in differentiation of ambiguous or suspicious lesions found on conventional imaging, such like mammography or ultrasound, has not been reported. We have had an ongoing preliminary study regarding breast lesion diagnosis using 18F-FLT PET, with an overall sensitivity 100% and specificity 92.7% in this dataset (from 2010 August to 2010 December, 19 lesions from 8 women with correlation with biopsy and clinical outcome).
On the other hand, the molecular subtypes of breast cancer, including ER (Estrogen receptor), PR (Progesterone receptor), HER2 (Human epidermal growth factor receptor 2) are associated with treatment planning and prediction of clinical outcome of breast cancer. There have been documented reports regarding the relation of mammography, DCE MRI, 18F-FDG PET to ER, PR, HER2 status of breast cancers. But the association of proton MRS, DWI and 18F-FLT PET with ER, PR, HER2 status was seldom reported.
- Conditions
- Breast Cancer
- Being tested
- PET
- Keywords
- Breast neoplasms, PET, MRI
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PETDrug
Also called 3'-deoxy-3'-[18F]fluorothymidine PET
18F-FLT PET and MRI of the breast
| Study group | Role | What they receive |
|---|---|---|
| diagnostic accuracy | Other | diagnostic accuracy of PET and MRI for breast cancer diagnosis. Receives: Drug: PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy of 18F-FLT PET and MRI
to measure diagnostic accuracy (sensitivity, specificity) of 18F-FLT PET and MRI for localized breast findings seen on mammography and breast ultrasound.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startJun 2011
- Primary completionDec 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jane Wang, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956890
- Sponsor's protocol ID
- 201102011MB
- Status last verified
- Oct 2013
- First submitted
- 24 Sep 2013
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Diagnosis of 18F-FLT Positron Emission Tomography and Magnetic Resonance Imaging to Evaluate the Suspicious Findings on Mammography and Breast Ultrasound: a Pilot Study
- ClinicalTrials.gov ID
- NCT01956890
- Acronym / sponsor ID
- 201102011MB
- Conditions
- Breast Cancer
- Keywords
- Breast neoplasms, PET, MRI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 8 Oct 2013 (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.
This prospective study is aimed to evaluate the diagnostic effectiveness of 18F-FLT PET in differentiating benign nature from malignancy for lesions with suspicious or ambiguous findings on mammography or ultrasound; to determine whether 18F-FLT PET or MRI can increase the specificity in breast lesion diagnosis and thus reduce the unnecessary biopsy, and which (18F-FLT PET or MRI) reveals the higher diagnostic performance.
Detailed description
It has been reported that PET (Positron Emission Tomography) scan is also useful in diagnosing breast cancer. 18F-fluorodeoxyglucose (18F-FDG), which based on glucose metabolism for the determination of malignancy, is the most popular PET tracer at present. However, 18F-FDG is not tumor specific. Benign inflammatory lesions may also demonstrate increase in 18F-FDG uptake. On the other hand, low grade malignancy may have low 18F-FDG concentration. Recently, 18F-3'-fluoro-3'-deoxy-L-thymidine (18F-FLT), a radiolabelled analog of thymidine, has been used in imaging cell proliferation and monitoring of treatment effects for breast cancer patients. 18F-FLT is believed to be more specific than 18F-FDG for breast cancer diagnosis and may provide the underlined physiological and molecular manifestations of breast lesions in addition to anatomical manifestations from mammography, ultrasound or MRI. Yet, its potential role in differentiation of ambiguous or suspicious lesions found on conventional imaging, such like mammography or ultrasound, has not been reported. We have had an ongoing preliminary study regarding breast lesion diagnosis using 18F-FLT PET, with an overall sensitivity 100% and specificity 92.7% in this dataset (from 2010 August to 2010 December, 19 lesions from 8 women with correlation with biopsy and clinical outcome).
On the other hand, the molecular subtypes of breast cancer, including ER (Estrogen receptor), PR (Progesterone receptor), HER2 (Human epidermal growth factor receptor 2) are associated with treatment planning and prediction of clinical outcome of breast cancer. There have been documented reports regarding the relation of mammography, DCE MRI, 18F-FDG PET to ER, PR, HER2 status of breast cancers. But the association of proton MRS, DWI and 18F-FLT PET with ER, PR, HER2 status was seldom reported.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diagnostic accuracy | Other | Drug: PETdiagnostic accuracy of PET and MRI for breast cancer diagnosis. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Women aged between 20 to 80 years 2) women who have localized findings on mammography and / or ultrasound and will receive biopsy 3) The lesions on the conventional imaging measure >=1cm 4) WBC count >=3000/L, or platelet>=75,000/L 5) Liver function, AST or ALT <78 U/L 6) Renal function, Creatinine <2.0 mg/dl., and estimated GFR(eGFR)>60ml/min/1.73m2.
Key exclusion criteria (4 listed)
- 1) Pregnant women or who are planning to be pregnant, or who are lactating. (Eligible women who are premenopausal with reproductive potential should receive urine pregnancy test before the MRI and PET. Women with a positive pregnancy test should be excluded from the study.) 2) Known cancers in other organs. 3) Women who are not able to cooperate with the PET/CT examination, or MRI examination.
- 4) Women≦19 years old. 5) Past history of severe anaphylactoid reaction to MRI-contrast agent or 18F-FLT.
- 6) History of mechanical valve replacement, recent coronary artery stent placement, with pacemaker, aneurysmal clip, metallic endotracheal tube, or other procedures with metallic device application.
- 7) eGFR≦60ml/min/1.73m2. 8) History of acute renal failure, or renal dialysis.
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 |
|---|---|---|
| PETAlso: 3'-deoxy-3'-[18F]fluorothymidine PET18F-FLT PET and MRI of the breast | Drug | diagnostic accuracy |
Primary outcome
diagnostic accuracy of 18F-FLT PET and MRI
Time frame: 5 years
to measure diagnostic accuracy (sensitivity, specificity) of 18F-FLT PET and MRI for localized breast findings seen on mammography and breast ultrasound.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2013.
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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 Phase 4 study testing PET in people with Breast 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 1 inclusion and 4 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 16 Oct 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jane Wang, PhD (886223123456 ext. 65565, hstjen@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic accuracy of 18F-FLT PET and MRI (time frame: 5 years). 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 16 Oct 2013; AzTrials last refreshed its copy on 8 Nov 2026.