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

Early Phase 1

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: 68GA-DOTA-dPNE

• Registration Number: NCT06411678
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-08
• Study First Submitted QC: 2024-05-08
• Study Start: 2024-05-10
• Study First Posted: 2024-05-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-28
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68GA-DOTA-dPNE	68GA-DOTA-dPNE	Each patient receive a single intravenous injection of 68GA-DOTA-dPNE 0.5-0.6 mci/kg and undergo PET/CT

Primary Outcome Measures

Name	Time	Method
The evaluation of diagnostic performance of 68Ga-DOTA-dPNE PET in breast cancer	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.

Trial Locations

Locations (1)

PUMCH; 🇨🇳 Dongcheng, Beijing, China