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

Overview

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.

Interventions

• Drug 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
• Drug [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.

Primary outcome measures

• Diagnostic performance of [68Ga]Ga-TTP PET compared with [18F]FDG PET for breast cancer lesions [Time frame: 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 [Time frame: 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.]

Secondary outcome measures (3)

• Correlation between [68Ga]Ga-TTP uptake and TROP2 expression in tumor tissue [Time frame: 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 [Time frame: 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 [Time frame: Within 2 months after imaging]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

China · 1 center

• Peking University Cancer Hospital & Institute — Beijing

Identifiers

NCT: NCT06715020 · 2024KT104

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗