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

Phase 1

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: 18F-Alfatide Ⅱ PET/CT

• Registration Number: NCT02582801
• Lead Sponsor: Jiang Wu

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-21
• Primary Completion: 2018-10
• Status Verified: 2019-09
• Study Completion: 2019-09
• Last Update Submitted: 2019-09-25
• Last Update Posted: 2019-09-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
breast cancer	18F-Alfatide Ⅱ PET/CT	Perform 18F-Alfatide Ⅱ PET/CT in breast cancer patients
benign breast lesions	18F-Alfatide Ⅱ PET/CT	Perform 18F-Alfatide Ⅱ PET/CT in patients with benign breast lesions

Primary Outcome Measures

Name	Time	Method
Maximum standardized uptake value (SUVmax)	1 day	the uptake intensity of lesions

Trial Locations

Locations (1)

Jinling Hospital; 🇨🇳 Nanjing, Jiangsu, China