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

NCT02582801 | Terminated Phase 1 DMC

• 1 other identifier: Molecular Imaging
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

PET/CT; Alfatide Ⅱ; breast cancer

Outcome Measures

Primary Outcomes (1)

• Maximum standardized uptake value (SUVmax)

  the uptake intensity of lesions

  1 day

Study Arms (2)

breast cancer

EXPERIMENTAL

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

Drug: 18F-Alfatide Ⅱ PET/CT

benign breast lesions

ACTIVE COMPARATOR

Perform 18F-Alfatide Ⅱ PET/CT in patients with benign breast lesions

Drug: 18F-Alfatide Ⅱ PET/CT

Interventions

18F-Alfatide Ⅱ PET/CT DRUG

Inject 18F-Alfatide Ⅱ by vein and then perform PET/CT scan after 60 min

Also known as: 18F-AlF-NOTA-E[PEG4-c(RGDfk)]2

benign breast lesions; breast cancer

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy or nursing mothers; Those patients accompanied by other serious diseases such as cardiac functional insufficiency, hepatic and renal function insufficiency.

Sponsors & Collaborators

• Jiang Wu: lead

Study Sites (1)

Jinling Hospital

Nanjing, Jiangsu, 210002, China

Location

Related Publications (5)

• 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.

  PMID: 26121930 BACKGROUND

• 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.

  PMID: 26218449 BACKGROUND

• 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.

  PMID: 26199649 BACKGROUND

• 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.

  PMID: 24672585 BACKGROUND

• 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.

  PMID: 24232871 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

alfatide II

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Guangming Lu, Professor

  Jinling Hospital, China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 21, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: September 1, 2019
• Last Updated: September 27, 2019

Record last verified: 2019-09

Locations

CN (1)