18F-FLT Positron Emission Tomography and Magnetic Resonance Imaging of the Breast
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|ClinicalTrials.gov Identifier: NCT01956890|
Recruitment Status : Unknown
Verified October 2013 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : October 8, 2013
Last Update Posted : October 16, 2013
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: PET||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||March 2016|
diagnostic accuracy of PET and MRI for breast cancer diagnosis.
18F-FLT PET and MRI of the breast
Other Name: 3'-deoxy-3'-[18F]fluorothymidine PET
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956890
|Contact: Jane Wang, PhD||886223123456 ext email@example.com|
|National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 100|
|Contact: Jane Wang, PhD 886223123456 ext 65565 firstname.lastname@example.org|
|Principal Investigator: Jane Wang, PhD|
|Principal Investigator:||Jane Wang, PhD||National Taiwan University Hospital|