Breast Cancer
Conditions
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.
Interventions
DRUG18F-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 approximately 0.1-0.15 mCi/kg.
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.
Sponsors
Peking University Cancer Hospital & Institute
Yunnan Cancer Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance of [68Ga]Ga-TTP PET compared with [18F]FDG PET for breast cancer lesions | Within 1 week after paired baseline imaging and within 2 months of follow-up/reference standard assessment | To compare the diagnostic performance of \[68Ga\]Ga-TTP PET and \[18F\]FDG PET for breast cancer lesions, including sensitivity, specificity, accuracy, false-positive rate, and false-negative rate, using pathology and/or integrated follow-up assessment as reference standard. |
| Change in [68Ga]Ga-TTP uptake in relation to ADC treatment response | 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. | To evaluate the association between changes in tumor uptake on \[68Ga\]Ga-TTP PET (e.g., SUV or SUVmax) before treatment, after 2 cycles of TROP2-directed ADC therapy(each cycle is 21 days), and at disease progression, and clinical treatment response in patients with breast cancer receiving ADC therapy.assessed up to 24 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between [68Ga]Ga-TTP uptake and TROP2 expression in tumor tissue | At baseline PET/CT imaging and from 4 weeks before to 8 weeks after baseline imaging for pathological tissue assessment. | To evaluate the correlation between standardized uptake values of \[68Ga\]Ga-TTP PET in target or suspected tumor lesions and TROP2 expression level in corresponding pathological tissue samples. |
| Biodistribution and temporal distribution pattern of [68Ga]Ga-TTP in patients | 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. | To assess the in vivo biodistribution, organ uptake, and temporal distribution characteristics of \[68Ga\]Ga-TTP in patients with breast cancer at different imaging time windows. |
| Pathological results of lesions suspected to be positive on [68Ga]Ga-TTP PET | Within 2 months after imaging | To assess the pathological findings of lesions suspected to be positive on \[68Ga\]Ga-TTP PET imaging, including concordance with biopsy or surgical pathology when available. |
Countries
China
Contacts
CONTACTZhi Yang
CONTACTGuojun Zhang
Outcome results
None listed