Establishment and Clinical Transformation of ADC Drug Efficacy Evaluation System for Breast Cancer Based on Molecular Imaging
- Registration Number
- NCT06715020
- Lead Sponsor
- Peking University Cancer Hospital & Institute
- Brief Summary
The objective of the study is to construct a noninvasive approach 68Ga-TTP PET/CT to detect the TROP2 expression of tumor lesions in patients with breast tumors and evaluate the efficacy of ADC drug therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Age 18-75 years old, male or female, ECOG score 0 or 1 points (see the table in Annex 2 for the score table);
- Blood routine and liver and kidney function meet the following criteria: Blood routine: WBC ≥ 4.0×109 L or neutrophil ≥1.5×109 /L, PLT ≥ 100×109/L, Hb≥ 90 g/L; PT or APTT ≤ 1.5 ULN; Liver and kidney function: T-Bil ≤ 1.5×ULT(upper limit of normal), ALT and AST≤ 2.5 ULN or ≤ 5×ULT(subjects with liver metastasis), ALP ≤ 2.5 ULN(ALP ≤ 4.5 ULN if there is bone metastasis or liver metastasis); BUN ≤ 1.5×ULT, SCr ≤ 1.5×ULT;
- Patients with confirmed or suspected breast cancer;
- Expected survival ≥12 weeks;
- Good follow-up compliance;
- Women of childbearing age (15 to 49 years old) must undergo a pregnancy test within 7 days before the start of the test and the result is negative; Fertile men and women must consent to the use of effective contraception to ensure pregnancy during the study period and within 3 months of the examination;
- Subject patients can fully understand and voluntarily participate in this experiment, and sign informed consent.
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Exclusion Criteria
- Severe abnormal liver and kidney function;
- Pregnant, pregnant and lactating women;
- Can not lie flat for half an hour;
- Unable to obtain informed consent;
- Suffering from claustrophobia or other mental illness;
- People who are known to be allergic to the investigational drug or its excipients in the investigational therapy;
- Other conditions deemed unsuitable for participation in the trial by the investigator.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 68Ga-TTP 18F-FDG All study participants will be allocated to this arm (single-arm study).Study participants will undergo 68Ga-TTP PET scans
- Primary Outcome Measures
Name Time Method Standardized uptake value(SUV) 2 years The uptake of the tracer (68Ga-TTP) in solid tumor lesions or suspected tumor lesions by measuring SUV on PET/CT.
- Secondary Outcome Measures
Name Time Method