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Trial Title:
Positron Emission Tomograph(PET) Imaging Explores the Role of SF-DEVD-2 in Monitoring Tumor Efficacy
NCT ID:
NCT05828238
Condition:
Breast Cancer Stage II
Breast Cancer Stage III
Solid Tumor
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[18F]SF-DEVD-2
Description:
Patients will receive a tracer dose of 18F (2-4mCi) labelled SF-DEVD-2
Arm group label:
[18F]SF-DEVD-2
Intervention type:
Drug
Intervention name:
[18F]-FDG
Description:
Patients will receive a tracer dose of 18F (5-10mCi) labelled FDG
Arm group label:
[18F]SF-DEVD-2
Summary:
This is a single arm study to determining the value of apoptotic molecular probe
SF-DEVD-2 in the early evaluation of tumor efficacy and comparing it head-to-head wihe
18F-FDG(18F-2-fluoro-2-deoxy-D-glucose)
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients voluntarily signed informed consent;
2. Age18-70, male or female;
3. Diagnosed with stage 2 or 3 breast cancer
4. Solid tumors、masses larger than 2cm with lymph node metastasis
5. Pathology is HER3+、triple negative patients
6. Patients to be treated with neoadjuvant chemotherapy
Exclusion Criteria:
1. Age greater than or equal to 70 years old
2. Abnormal liver and kidney function (more than five times the normal value)
3. Diagnosis level of breast cancer stage 4 or second time tumor patients
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Affiliated Hospital of Jiangnan University
Address:
City:
Wuxi
Zip:
214000
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunjing Yu
Phone:
15312238622
Email:
ycj_wxd1978@163.com
Start date:
January 2023
Completion date:
January 2024
Lead sponsor:
Agency:
Affiliated Hospital of Jiangnan University
Agency class:
Other
Source:
Affiliated Hospital of Jiangnan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05828238
