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

Status

Terminated

Conditions

Intervention / Treatment

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

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Jinling Hospital

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
Drug: 18F-Alfatide Ⅱ PET/CT
Inject 18F-Alfatide Ⅱ by vein and then perform PET/CT scan after 60 min
Other Names:
  • 18F-AlF-NOTA-E[PEG4-c(RGDfk)]2
Active Comparator: benign breast lesions
Perform 18F-Alfatide Ⅱ PET/CT in patients with benign breast lesions
Drug: 18F-Alfatide Ⅱ PET/CT
Inject 18F-Alfatide Ⅱ by vein and then perform PET/CT scan after 60 min
Other Names:
  • 18F-AlF-NOTA-E[PEG4-c(RGDfk)]2

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

Jiang Wu

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

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.

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