Recruiting

NCT Number: NCT06411678

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

PUMCH

Dongcheng, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Chenhao JIA

CONTACT

[email protected]

18548703382

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

68GA-DOTA-dPNE

Drug

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

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chenhao JIA

CONTACT

[email protected]

18548703382

Xianzhong ZHANG

CONTACT

[email protected]

18950190564

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: May 13, 2024
Registry last updated: Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting