RecruitingEarly Phase 1NCT06411678

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


Sponsor

Peking Union Medical College Hospital

Enrollment

50 participants

Start Date

May 10, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Inclusion Criteria1

  • 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 Criteria1

  • 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

Interventions

DRUG68GA-DOTA-dPNE

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


Locations(1)

PUMCH

Dongcheng, Beijing Municipality, China

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NCT06411678


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