Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-01-04 @ 9:31 AM
Study NCT ID:
NCT02742168
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2016-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
99mTc-3PRGD2 SPECT/CT in Breast Cancer Patients
Sponsor:
First Affiliated Hospital of Fujian Medical University
Organization:
Study Overview
Official Title:
Clinical Study of 99mTc-3PRGD2 SPECT/CT in Diagnosis and Efficacy Evaluation of Breast Cancer
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
Integrin αvβ3 is an important member of integrin receptor family and expressed preferentially on the activated endothelial cells of angiogenesis and some types of tumor cells, but not or very low on the quiescent vessel cells and other normal cells. Therefore, the integrin αvβ3 receptor is becoming a valuable target for diagnosis and response evaluation of malignant tumors.
The tri-peptide sequence of arginine-glycine-aspartic acid (RGD) can specifically bind to the integrin αvβ3 receptor. Accordingly, a variety of radiolabeled RGD-based peptides have been developed for non-invasive imaging of integrin αvβ3 expression via single photon emission computed tomography (SPECT)or positron emission tomography (PET). Among all the RGD radiotracers studied, several RGD monomers have been investigated in clinical trials, and the preliminary results demonstrated specific imaging of various types of tumors, and the tumor uptake correlated well with the level of integrin αvβ3 expression. Recently, several RGD dimeric peptides with PEG linkers have been studied. The new types of RGD peptides showed much higher in vitro integrin αvβ3-binding affinity than the single RGD tri-peptide sequence, and importantly, they exhibited significantly increased tumor uptake and improved in vivo kinetics in animal models. As a representative, 99mTc-3PRGD2 could be easily prepared and exhibited excellent in vivo behaviors in animal models. No adverse reactions are observed in animal models to date.
For the further interests in clinical trial of 99mTc-3PRGD2, an open-label SPECT/CT (single photon emission computed tomography / computed tomography) study to investigate 99mTc-3PRGD2 SPECT/CT in diagnosis and efficacy evaluation of breast cancer. A single dose of nearly 0.3 mCi/kg body weight 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. Adverse events will also be observed in the patients.
The tri-peptide sequence of arginine-glycine-aspartic acid (RGD) can specifically bind to the integrin αvβ3 receptor. Accordingly, a variety of radiolabeled RGD-based peptides have been developed for non-invasive imaging of integrin αvβ3 expression via single photon emission computed tomography (SPECT)or positron emission tomography (PET). Among all the RGD radiotracers studied, several RGD monomers have been investigated in clinical trials, and the preliminary results demonstrated specific imaging of various types of tumors, and the tumor uptake correlated well with the level of integrin αvβ3 expression. Recently, several RGD dimeric peptides with PEG linkers have been studied. The new types of RGD peptides showed much higher in vitro integrin αvβ3-binding affinity than the single RGD tri-peptide sequence, and importantly, they exhibited significantly increased tumor uptake and improved in vivo kinetics in animal models. As a representative, 99mTc-3PRGD2 could be easily prepared and exhibited excellent in vivo behaviors in animal models. No adverse reactions are observed in animal models to date.
For the further interests in clinical trial of 99mTc-3PRGD2, an open-label SPECT/CT (single photon emission computed tomography / computed tomography) study to investigate 99mTc-3PRGD2 SPECT/CT in diagnosis and efficacy evaluation of breast cancer. A single dose of nearly 0.3 mCi/kg body weight 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. Adverse events will also be observed in the patients.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: