Target-specific immunoPET Imaging of Breast Cancer
Recruiting
Phase 1Phase 2Interventional Study
Breast CancerBreast NeoplasmsBreast Cancer Metastatic
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Female
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Diagnostic
Participants needed
200 (estimated)
Sponsor
RenJi Hospital · Other
Who this trial is looking for
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The aim of this study is to establish and optimize the Trop2/HER2-targeted PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in breast cancer will be evaluated.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Aged 18-75 years old and of female gender;
2. Histologically confirmed diagnosis of breast cancer or suspected breast cancer by diagnostic imaging;
3. Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed…
Inclusion Criteria:
1. Aged 18-75 years old and of female gender;
2. Histologically confirmed diagnosis of breast cancer or suspected breast cancer by diagnostic imaging;
3. Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.
Exclusion Criteria:
1. Pregnancy;
2. Severe hepatic and renal insufficiency;
3. History of serious surgery in the last month;
4. Allergic to antibody or single-domain antibody radiopharmaceuticals.
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