Clinical Research of 18F-Alfatide Ⅱ PET/CT in Breast Cancer

Breast Cancer Clinical Trial

Official title:

18F-Alfatide Ⅱ PET/CT in the Diagnosis and Treatment Response Evaluation of Breast Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02582801
• Other study ID #: Molecular Imaging
• Status: Terminated
• Phase: Phase 1
• Start date: October 2015
• Est. completion date: September 2019

Study information

• Verified date: September 2019
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

18F-Alfatide Ⅱ PET/CT in breast cancer patients

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: September 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• 18F-Alfatide ? PET/CT
Inject 18F-Alfatide ? by vein and then perform PET/CT scan after 60 min

Locations

Country	Name	City	State
China	Jinling Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiang Wu

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum standardized uptake value (SUVmax)	the uptake intensity of lesions	1 day