Back to resultsClinical Research of 18F-Alfatide Ⅱ PET/CT in Breast Cancer
Primary Purpose
Breast Cancer
Status
Terminated
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
18F-Alfatide Ⅱ PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring PET/CT, Alfatide Ⅱ, breast cancer
Eligibility Criteria
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.
Sites / Locations
- Jinling Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
breast cancer
benign breast lesions
Arm Description
Perform 18F-Alfatide Ⅱ PET/CT in breast cancer patients
Perform 18F-Alfatide Ⅱ PET/CT in patients with benign breast lesions
Outcomes
Primary Outcome Measures
Maximum standardized uptake value (SUVmax)
the uptake intensity of lesions
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02582801
Brief Title
Clinical Research of 18F-Alfatide Ⅱ PET/CT in Breast Cancer
Official Title
18F-Alfatide Ⅱ PET/CT in the Diagnosis and Treatment Response Evaluation of Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
The cyclotron in our hospital has a serious malfunction and can not be repaired. It will take a long time to purchase and install the new cyclotron.
Study Start Date
October 2015 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
September 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jiang Wu
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
18F-Alfatide Ⅱ PET/CT in breast cancer patients
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
PET/CT, Alfatide Ⅱ, breast cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
breast cancer
Arm Type
Experimental
Arm Description
Perform 18F-Alfatide Ⅱ PET/CT in breast cancer patients
Arm Title
benign breast lesions
Arm Type
Active Comparator
Arm Description
Perform 18F-Alfatide Ⅱ PET/CT in patients with benign breast lesions
Intervention Type
Drug
Intervention Name(s)
18F-Alfatide Ⅱ PET/CT
Other Intervention Name(s)
18F-AlF-NOTA-E[PEG4-c(RGDfk)]2
Intervention Description
Inject 18F-Alfatide Ⅱ by vein and then perform PET/CT scan after 60 min
Primary Outcome Measure Information:
Title
Maximum standardized uptake value (SUVmax)
Description
the uptake intensity of lesions
Time Frame
1 day
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guangming Lu, Professor
Organizational Affiliation
Jinling Hospital, China
Official's Role
Study Chair
Facility Information:
Facility Name
Jinling Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26121930
Citation
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.
Results Reference
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PubMed Identifier
26218449
Citation
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.
Results Reference
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PubMed Identifier
26199649
Citation
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.
Results Reference
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PubMed Identifier
24672585
Citation
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.
Results Reference
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PubMed Identifier
24232871
Citation
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.
Results Reference
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Clinical Research of 18F-Alfatide Ⅱ PET/CT in Breast Cancer
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