Breast CancerNCT02742168
99mTc-3PRGD2 SPECT/CT in Breast Cancer Patients
A study testing 99mTc-3PRGD2 in people with Breast Cancer, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 99mTc-3PRGD2
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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:
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
About this study
Official title: Clinical Study of 99mTc-3PRGD2 SPECT/CT in Diagnosis and Efficacy Evaluation of Breast Cancer
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- 99mTc-3PRGD2
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc-3PRGD2Radiation
Also called 99mTc-HYNIC-3PRGD2
Diagnostic group：For patients in suspicion of breast cancer, single intravenous bolus injection of nearly 0.3 mCi/kg body weight of 99mTc-3PRGD2 on day one of the treatment period, whole-body planar and lesions SPECT/CT to determine the accumulation of 99mTc-3PRGD2 in the tumors and the other parts of the body.
Efficacy evaluation group：patients firstly diagnose with malignant lesions ,and prepare to chemotherapy(including neoadjuvant chemotherapy) or radiotherapy.the same dose of 99mTc-3PRGD2 will be intravenously injected into the patients before treatment ,the second period,the sixth period( almost three months after the initial treatment)，whole-body planar and lesions SPECT/CT to assess the value of 99mTc-3PRGD2 in evaluation of cancers.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer,99mTc-3PRGD2,SPECT/CT | Experimental | Determine if 99mTc-3PRGD2 SPECT/CT is safe and effective in diagnosis and efficacy evaluation of breast cancer Receives: Radiation: 99mTc-3PRGD2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Assessment of Breast Lesions in 99mTc-3PRGD2 SPECT/CT Scan
Visual analysis will be performed by 3 experienced nuclear medicine physicians to observe the the uptake of 99mTc-3PRGD2 on breast lesions. The visual analysis interpreter's degree of suspicion for an abnormality was recorded with use of a 3-point with the following categories: score 1, no abnormal increased uptake; score 2, mildly increased uptake; score 3, definite focal increased uptake. The lesion was considered positive as malignancy if the lesion scored as 2 or higher.
Measured: One year
Semiquantitative Assessment of Breast Lesions in 99mTc-3PRGD2 SPECT/CT Scan
The semiquantitative analysis of the standardized uptake values (SUV) of 99mTc-3PRGD2 SPECT/CT was performed on breast lesion.
Measured: One year
Secondary outcomes (4)
Adverse events collection
Adverse events within 5 days after the injection and scanning of the patients will be followed and assessed.
Measured: 5 days
Mammography and/or ultrasound
Mammography and/or ultrasound will be carried out in breast cancer patients to observe the location and tumor diameter (cm).
Measured: One year
18F-FDG PET/CT scan
18F-FDG PET/CT will be carried out in breast cancer patients to assess the uptake of breast lesions, the axillary lymph node metastasis or distant metastasis and the standardized uptake values (SUVs) of these lesions will be measured.
Measured: One year
carbohydrate antigen 153
The patients will be required to test level of carbohydrate antigen 153 (CA153, U/L) routinely.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startJan 2016
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The participants were underwent the 99mTc-3PRGD2 imaging and 18F-FDG imaging within one week.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weibing Miao, PhD, First Affiliated Hospital of Fujian Medical University
- Investigators
- Weibing Miao, MD, Principal investigator, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742168
- Sponsor's protocol ID
- FirstAHFujian2
- Status last verified
- Jul 2020
- First submitted
- 8 Mar 2016
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Chen 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.
PubMed 29497956
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of 99mTc-3PRGD2 SPECT/CT in Diagnosis and Efficacy Evaluation of Breast Cancer
- ClinicalTrials.gov ID
- NCT02742168
- Acronym / sponsor ID
- FirstAHFujian2
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 18 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The participants were underwent the 99mTc-3PRGD2 imaging and 18F-FDG imaging within one week.
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer,99mTc-3PRGD2,SPECT/CT | Experimental | Radiation: 99mTc-3PRGD2Determine if 99mTc-3PRGD2 SPECT/CT is safe and effective in diagnosis and efficacy evaluation of breast cancer |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Males and females, ≥20 years old.
- Firstly and definitely diagnose with malignant tumors ,and prepare to chemotherapy (including neoadjuvant chemotherapy) or radiotherapy.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 99mTc-3PRGD2Also: 99mTc-HYNIC-3PRGD2Diagnostic group：For patients in suspicion of breast cancer, single intravenous bolus injection of nearly 0.3 mCi/kg body weight of 99mTc-3PRGD2 on day one of the treatment period, whole-body planar and lesions SPECT/CT to determine the accumulation of 99mTc-3PRGD2 in the tumors and the other parts of the body. Efficacy evaluation group：patients firstly diagnose with malignant lesions ,and prepare to chemotherapy(including neoadjuvant chemotherapy) or radiotherapy.the same dose of 99mTc-3PRGD2 will be intravenously injected into the patients before treatment ,the second period,the sixth period( almost three months after the initial treatment)，whole-body planar and lesions SPECT/CT to assess the value of 99mTc-3PRGD2 in evaluation of cancers. | Radiation | Breast Cancer,99mTc-3PRGD2,SPECT/CT |
Primary outcome
Visual Assessment of Breast Lesions in 99mTc-3PRGD2 SPECT/CT Scan
Time frame: One year
Visual analysis will be performed by 3 experienced nuclear medicine physicians to observe the the uptake of 99mTc-3PRGD2 on breast lesions. The visual analysis interpreter's degree of suspicion for an abnormality was recorded with use of a 3-point with the following categories: score 1, no abnormal increased uptake; score 2, mildly increased uptake; score 3, definite focal increased uptake. The lesion was considered positive as malignancy if the lesion scored as 2 or higher.
Semiquantitative Assessment of Breast Lesions in 99mTc-3PRGD2 SPECT/CT Scan
Time frame: One year
The semiquantitative analysis of the standardized uptake values (SUV) of 99mTc-3PRGD2 SPECT/CT was performed on breast lesion.
4 secondary outcomes
Adverse events collection
Time frame: 5 days
Mammography and/or ultrasound
Time frame: One year
18F-FDG PET/CT scan
Time frame: One year
carbohydrate antigen 153
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Derived from this study: PubMed 29497956Chen 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weibing Miao, MD principal investigator
First Affiliated Hospital of Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 99mTc-3PRGD2 in people with Breast Cancer, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Assessment of Breast Lesions in 99mTc-3PRGD2 SPECT/CT Scan (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02742168, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.