99mTc-3PRGD2 SPECT/CT in Breast Cancer Patients

This is an open-label SPECT/CT (single photon emission computed tomography / computed tomography) study to investigate clinical study of 99mTc-3PRGD2 SPECT/CT in diagnosis and efficacy evaluation of breast cancer. Diagnostic group: for patients in suspicion of breast cancer. The standard of truth for diagnosis was based on histopathologic findings after surgical removal of the tumor or a definite diagnosis from fine needle aspiration biopsy. A single dose of nearly 0.3 mCi/kg (milli-Curie/kilogram) body weight of 99mTc-3PRGD2 ( ≤ 20 µg 3PRGD2) will be intravenously injected into the patients. Visual and semiquantitative method will be used to assess the whole-body planar and lesions SPECT/CT images. Efficacy evaluation group: for patients firstly diagnose with malignant tumors (breast cancer), and prepare to chemotherapy(including neoadjuvant chemotherapy) or radiotherapy. The standard of truth for diagnosis was based on histopathologic findings after fine needle aspiration biopsy. A single dose of nearly 0.3 mCi/kg body weight of 99mTc-3PRGD2 ( ≤ 20 µg 3PRGD2) will be intravenously injected into the patients before treatment, the second period, sixth period. Visual,semiquantitative method will be used to assess the whole-body planar and lesions SPECT/CT images. By comparing with result of the other related imaging, for instance, PET/CT (positron emission tomography/computed tomography), CT (computed tomography), MRI (magnetic resonance imaging), Doppler Ultrasound, Mammography, etc.

Sex

All

Minimum age

20 Years

Maximum age

70 Years

Diagnostic group：

Inclusion Criteria:

* Males and females, ≥20 years old.
* Part of lesion CT and/or 18F-FDG PET/CT and/or MRI and/or Doppler Ultrasound and/or Mammography diagnosis in suspicion of primary or recurrent breast cancer.
* The above cancers will be histologically confirmed or results of histology will be available.

Exclusion Criteria:

* Females planning to bear a child recently or with childbearing potential.
* Known severe allergy.
* Inability to lie still for the entire imaging time because of cough, pain, etc.
* Inability to complete the needed examinations due to severe claustrophobia,radiation phobia, etc.
* Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance.

Efficacy evaluation group:

Inclusion Criteria:

* Males and females, ≥20 years old.
* Firstly and definitely diagnose with malignant tumors ,and prepare to chemotherapy (including neoadjuvant chemotherapy) or radiotherapy.
* There are available lesions for assessment during the trial.
* Part of lesion CT and/or 18F-FDG PET/CT and/or MRI and/or Doppler Ultrasound and/or Mammography examination before treatment, the mid tern treatment, post-treatment( three months after the initial treatment) are available.

Exclusion Criteria:

* Females planning to bear a child recently or with childbearing potential.
* Known severe allergy or hypersensitivity to IV radiographic contrast.
* Inability to lie still for the entire imaging time because of cough, pain, etc.
* Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.
* Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance.

• DERIVEDChen Z, Fu F, Li F, Zhu Z, Yang Y, Chen X, Jia B, Zheng S, Huang C, Miao W. Comparison of [99mTc]3PRGD2 Imaging and [18F]FDG PET/CT in Breast Cancer and Expression of Integrin alphavbeta3 in Breast Cancer Vascular Endothelial Cells. Mol Imaging Biol. 2018 Oct;20(5):846-856. doi: 10.1007/s11307-018-1178-y. PMID 29497956