Application of 68GA-labeled CD73 Targeting Probe PET/CT Imaging in the Diagnosis of Breast Cancer
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Chenhao JIA
- Phone Number: 18548703382
- Email: jiachenhao24@163.com
Study Contact Backup
- Name: Xianzhong ZHANG
- Phone Number: 18950190564
- Email: zhangxzh@pumch.cn
Study Locations
-
-
Beijing
-
Dongcheng, Beijing, China, 100730
- Recruiting
- PUMCH
-
Contact:
- Chenhao JIA
- Phone Number: 18548703382
- Email: jiachenhao24@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Female patients aged ≥18 years with an expected survival of at least 12 weeks No prior radiotherapy or chemotherapy; surgery or biopsy is feasible for pathological diagnosis At least one measurable target lesion as defined by RECIST v1.1 Able to provide written informed consent and comply with follow-up requirements
Exclusion Criteria:
Severe hepatic or renal dysfunction Pregnant, breastfeeding, planning to become pregnant, or planning to have children during the study period; women of childbearing potential must use effective contraception during the study Unable to lie flat for 30 minutes History of claustrophobia or other psychiatric disorders Any other condition deemed unsuitable for participation by the investigator Refusal to participate in the clinical study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 68GA-DOTA-dPNE
Each patient receive a single intravenous injection of 68GA-DOTA-dPNE 0.5-0.6 mci/kg and undergo PET/CT
|
Patients with breast cancer receive intravenously 68GA-DOTA-dPNE followed by PET/CT after 40min of injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The evaluation of diagnostic performance of 68Ga-DOTA-dPNE PET in breast cancer
Time Frame: through study completion, an average of 1 year
|
Patients with histologically proven breast cancer will be prospectively recruited in this study.
They will receive 68Ga-DOTA-dPNE and 18F-FDG.
The detection rates of lesions, bones and lymph nodes (visual) were compared.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Xianzhong Zhang, Peking Union Medical College Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PUMCH-NM-CD73
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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