Establishment and Clinical Transformation of ADC Drug Efficacy Evaluation System for Breast Cancer Based on Molecular Imaging

Обзор

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.

Вмешательства

• Препарат 18F-FDG
  \[18F\]FDG is administered intravenously as the comparator PET radiotracer. In the diagnostic validation cohort, participants undergo one \[18F\]FDG PET examination within 1 week of the \[68Ga\]Ga-TTP scan, with no treatment between scans. In the ADC response assessment cohort, participants undergo \[18F\]FDG PET imaging at the same three time points as \[68Ga\]Ga-TTP: before ADC therapy, after 2 cycles(each cycle is 21 days), and at disease progression. The planned administered activity is appr
• Препарат [68Ga]Ga-TTP
  \[68Ga\]Ga-TTP is a TROP2-targeted PET radiotracer administered intravenously for PET imaging. In the diagnostic validation cohort, participants undergo one \[68Ga\]Ga-TTP PET examination within 1 week of the comparator \[18F\]FDG scan. In the ADC response assessment cohort, participants undergo \[68Ga\]Ga-TTP PET imaging before ADC therapy, after 2 cycles of treatment(each cycle is 21 days), and at disease progression. The planned administered activity is approximately 0.05-0.1 mCi/kg.

Первичные конечные точки

• Diagnostic performance of [68Ga]Ga-TTP PET compared with [18F]FDG PET for breast cancer lesions [Срок оценки: Within 1 week after paired baseline imaging and within 2 months of follow-up/reference standard assessment]
• Change in [68Ga]Ga-TTP uptake in relation to ADC treatment response [Срок оценки: Baseline before ADC therapy, at the end of Cycle 2 of ADC therapy (each cycle is 21 days), and from the start of ADC therapy until first documented disease progression, assessed up to 24 months.]

Вторичные конечные точки (3)

• Correlation between [68Ga]Ga-TTP uptake and TROP2 expression in tumor tissue [Срок оценки: At baseline PET/CT imaging and from 4 weeks before to 8 weeks after baseline imaging for pathological tissue assessment.]
• Biodistribution and temporal distribution pattern of [68Ga]Ga-TTP in patients [Срок оценки: From injection to 40 minutes post-injection for dynamic PET imaging; at 50-60 minutes post-injection for routine static PET/CT imaging; and at 2 hours post-injection and 3 hours post-injection for delayed PET/CT imaging in the dynamic-imaging subgroup.]
• Pathological results of lesions suspected to be positive on [68Ga]Ga-TTP PET [Срок оценки: Within 2 months after imaging]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Китай · 1 центр

• Peking University Cancer Hospital & Institute — Пекин

Идентификаторы

NCT: NCT06715020 · 2024KT104

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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