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Establishment and Clinical Transformation of ADC Drug Efficacy Evaluation System for Breast Cancer Based on Molecular Imaging
RECRUITINGN/ASponsored by Peking University Cancer Hospital & Institute
Actively Recruiting
PhaseN/A
SponsorPeking University Cancer Hospital & Institute
Started2024-12-10
Est. completion2026-12
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06715020
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.
Eligibility
Age: 18 Years – 75 YearsHealthy volunteers accepted
Inclusion Criteria: 1. Age 18-75 years old, male or female, ECOG score 0 or 1 points (see the table in Annex 2 for the score table); 2. 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; 3. Patients with confirmed or suspected breast cancer; 4. Expected survival ≥12 weeks; 5. Good follow-up compliance; 6. 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; 7. Subject patients can fully understand and voluntarily participate in this experiment, and sign informed consent. Exclusion Criteria: 1. Severe abnormal liver and kidney function; 2. Pregnant, pregnant and lactating women; 3. Can not lie flat for half an hour; 4. Unable to obtain informed consent; 5. Suffering from claustrophobia or other mental illness; 6. People who are known to be allergic to the investigational drug or its excipients in the investigational therapy; 7. Other conditions deemed unsuitable for participation in the trial by the investigator.
Conditions2
Breast CancerCancer
Interventions2
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Actively Recruiting
PhaseN/A
SponsorPeking University Cancer Hospital & Institute
Started2024-12-10
Est. completion2026-12
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06715020