Clinical Research of 18F-Alfatide Ⅱ PET/CT in Breast Cancer
September 25, 2019 updated by: Jiang Wu
18F-Alfatide Ⅱ PET/CT in the Diagnosis and Treatment Response Evaluation of Breast Cancer Patients
18F-Alfatide Ⅱ PET/CT in breast cancer patients
Study Overview
Detailed Description
The investigators aim to assess the clinical application of 18F-Alfatide Ⅱ PET/CT in the diagnosis and treatment response monitoring of breast cancer.
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
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Nanjing, Jiangsu, China, 210002
- Jinling Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- The patients have been suspected or diagnosed with breast cancer and they have not received any treatment; It must fulfill the ethical requirements and subjects have signed an informed consent.
Exclusion Criteria:
- Pregnancy or nursing mothers; Those patients accompanied by other serious diseases such as cardiac functional insufficiency, hepatic and renal function insufficiency.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: breast cancer
Perform 18F-Alfatide Ⅱ PET/CT in breast cancer patients
|
Inject 18F-Alfatide Ⅱ by vein and then perform PET/CT scan after 60 min
Other Names:
|
|
Active Comparator: benign breast lesions
Perform 18F-Alfatide Ⅱ PET/CT in patients with benign breast lesions
|
Inject 18F-Alfatide Ⅱ by vein and then perform PET/CT scan after 60 min
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum standardized uptake value (SUVmax)
Time Frame: 1 day
|
the uptake intensity of lesions
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Guangming Lu, Professor, Jinling Hospital, China
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Yu C, Pan D, Mi B, Xu Y, Lang L, Niu G, Yang M, Wan W, Chen X. (18)F-Alfatide II PET/CT in healthy human volunteers and patients with brain metastases. Eur J Nucl Med Mol Imaging. 2015 Dec;42(13):2021-8. doi: 10.1007/s00259-015-3118-2. Epub 2015 Jul 1.
- Wang SY, Bao X, Wang MW, Zhang YP, Zhang YJ, Zhang JP. Radiation dosimetry estimates of (18)F-alfatide II based on whole-body PET imaging of mice. Appl Radiat Isot. 2015 Nov;105:1-5. doi: 10.1016/j.apradiso.2015.07.013. Epub 2015 Jul 13.
- Mi B, Yu C, Pan D, Yang M, Wan W, Niu G, Chen X. Pilot Prospective Evaluation of (18)F-Alfatide II for Detection of Skeletal Metastases. Theranostics. 2015 Jul 12;5(10):1115-21. doi: 10.7150/thno.12938. eCollection 2015.
- Wu C, Yue X, Lang L, Kiesewetter DO, Li F, Zhu Z, Niu G, Chen X. Longitudinal PET imaging of muscular inflammation using 18F-DPA-714 and 18F-Alfatide II and differentiation with tumors. Theranostics. 2014 Feb 26;4(5):546-55. doi: 10.7150/thno.8159. eCollection 2014.
- Guo J, Guo N, Lang L, Kiesewetter DO, Xie Q, Li Q, Eden HS, Niu G, Chen X. (18)F-alfatide II and (18)F-FDG dual-tracer dynamic PET for parametric, early prediction of tumor response to therapy. J Nucl Med. 2014 Jan;55(1):154-60. doi: 10.2967/jnumed.113.122069. Epub 2013 Nov 14.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2015
Primary Completion (Actual)
October 1, 2018
Study Completion (Actual)
September 1, 2019
Study Registration Dates
First Submitted
October 20, 2015
First Submitted That Met QC Criteria
October 20, 2015
First Posted (Estimate)
October 21, 2015
Study Record Updates
Last Update Posted (Actual)
September 27, 2019
Last Update Submitted That Met QC Criteria
September 25, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Molecular Imaging
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.