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

NCT06411678 | Recruiting Early Phase 1

• 1 other identifier: PUMCH-NM-CD73
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators plan to conduct a 68Ga-DOTA-dPNE PET/CT imaging study in breast cancer patients to observe the binding of the tracer to tumor lesions and evaluate CD73 expression. As part of the study design, a subset of patients will initially undergo dynamic PET/CT imaging to evaluate the safety profile and pharmacokinetic distribution of the radiotracer in vivo. Subsequently, static PET/CT imaging will be performed on additional patients to assess the diagnostic effectiveness of 68Ga-DOTA-dPNE. Imaging results will be correlated with relevant clinical indicators to evaluate the potential of this tracer in diagnosing breast cancer, guiding therapeutic decisions, and predicting responses to targeted therapies.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

68GA-DOTA-dPNE

EXPERIMENTAL

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

Drug: 68GA-DOTA-dPNE

Interventions

68GA-DOTA-dPNE DRUG

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

68GA-DOTA-dPNE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

PUMCH

Dongcheng, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Xianzhong ZHANG

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chenhao JIA

CONTACT

18548703382; jiachenhao24@163.com

Xianzhong ZHANG

CONTACT

18950190564; zhangxzh@pumch.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 13, 2024
• Study Start: May 10, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)