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

NCT ID: NCT02582801

Last Updated: 2019-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2019-09-30

Brief Summary

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

Detailed Description

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The investigators aim to assess the clinical application of 18F-Alfatide Ⅱ PET/CT in the diagnosis and treatment response monitoring of breast cancer.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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breast cancer

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

Group Type EXPERIMENTAL

18F-Alfatide Ⅱ PET/CT

Intervention Type DRUG

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

benign breast lesions

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

Group Type ACTIVE_COMPARATOR

18F-Alfatide Ⅱ PET/CT

Intervention Type DRUG

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

Interventions

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18F-Alfatide Ⅱ PET/CT

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

Intervention Type DRUG

Other Intervention Names

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18F-AlF-NOTA-E[PEG4-c(RGDfk)]2

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Jiang Wu

OTHER

Sponsor Role lead

Responsible Party

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Jiang Wu

Medical doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Guangming Lu, Professor

Role: STUDY_CHAIR

Jinling Hospital, China

Locations

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Jinling Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 26121930 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26218449 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26199649 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24672585 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24232871 (View on PubMed)

Other Identifiers

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Molecular Imaging

Identifier Type: -

Identifier Source: org_study_id

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