Positron Emission Tomograph(PET) Imaging Explores the Role of SF-DEVD-2 in Monitoring Tumor Efficacy

Solid Tumor Clinical Trial

Official title:

PET Imaging Explores the Role of SF-DEVD-2 in Monitoring Tumor Efficacy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05828238
• Other study ID #: LS2023012
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 2023
• Est. completion date: January 2024

Study information

• Verified date: April 2023
• Source: Affiliated Hospital of Jiangnan University
• Contact: Chunjing Yu
• Phone: 15312238622
• Email: ycj_wxd1978[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Stage II
• Breast Cancer Stage III
• Breast Neoplasms
• Solid Tumor

Intervention

Drug:
• [18F]SF-DEVD-2
Patients will receive a tracer dose of 18F (2-4mCi) labelled SF-DEVD-2
• [18F]-FDG
Patients will receive a tracer dose of 18F (5-10mCi) labelled FDG

Locations

Country	Name	City	State
China	Affiliated Hospital of Jiangnan University	Wuxi	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Jiangnan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of tissue distribution of [18F]-DEVD-2	Biodistribution of [18F] -DEVD-2 evaluated by the maximum standardized uptake value(SUVmax) in various organs during repeated [18F]-DEVD scans will be reported.	7 days