Application of 68GA-labeled CD73 Targeting Probe PET/CT Imaging in the Diagnosis of Breast Cancer

Breast Cancer Clinical Trial

Official title:

Application of 68GA-labeled CD73 Targeting Probe PET/CT Imaging in the Diagnosis of Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06411678
• Other study ID #: PUMCH-NM-CD73
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: May 10, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: April 2024
• Source: Peking Union Medical College Hospital
• Contact: Chenhao JIA
• Phone: 18548703382
• Email: jiachenhao24[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We plan to conduct a 68Ga-DOTA-dPNE PET/CT imaging study on breast cancer patients to observe the binding of the tracer to lesions and evaluate CD73 expression. Alongside this, we will correlate these imaging results with relevant clinical indicators to assess the effectiveness of 68Ga-DOTA-dPNE in diagnosing and guiding treatment in breast cancer patients. This study aims to predict responses to targeted therapies.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 1: Age: =18 years old female, expected survival =12 weeks; 2: Without radiotherapy and chemotherapy, surgery or biopsy is feasible to obtain pathological diagnosis; 3: Standard Solid Tumor Response Evaluation Criteria (RECIST) version 1.1 with at least one measurable target lesion; 4: Obtain written informed consent and be able to follow up

Exclusion Criteria:

• 1: Severe liver and kidney dysfunction; 2: Women who are planning to conceive, pregnant, or breastfeeding, as well as those planning to have children during the study period, are not eligible to participate in this research. Women of childbearing potential must use effective contraception throughout the course of the study; 3: Individuals unable to lie flat for thirty minutes; 4: Suffers from claustrophobia or other mental illnesses; 5: Researchers believe that the subject has other conditions that make them unsuitable for inclusion in this study; 6: Refuses to join this clinical study.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• 68GA-DOTA-dPNE
Patients with breast cancer receive intravenously 68GA-DOTA-dPNE followed by PET/CT after 40min of injection

Locations

Country	Name	City	State
China	PUMCH	Dongcheng	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The evaluation of diagnostic performance of 68Ga-DOTA-dPNE PET in breast cancer	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