Clinical trial · Interventional
Establishment and Clinical Transformation of ADC Drug Efficacy Evaluation System for Breast Cancer Based on Molecular Imaging
NCT06715020CI-TRIAL-00121371recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FDG | Drug | — | UNRESOLVED |
| [68Ga]Ga-TTP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Diagnostic Validation Cohort
- description
- Patients with newly diagnosed or suspected breast cancer will undergo one \[68Ga\]Ga-TTP scan and one \[18F\]FDG scan within 1 week, in randomized order, with no anticancer treatment administered between the two imaging examinations. This cohort is used to evaluate tumor targeting, compare diagnostic performance with \[18F\]FDG, and correlate imaging findings with pathology and TROP2 expression.
- interventionNames
- Drug: 18F-FDG
- Drug: [68Ga]Ga-TTP
- type
- EXPERIMENTAL
- label
- ADC Response Assessment Cohort
- description
- Patients with breast cancer who are planned to receive TROP2-directed ADC therapy will undergo paired \[68Ga\]Ga-TTP and \[18F\]FDG imaging at three time points: before treatment, after 2 cycles of ADC therapy(each cycle is 21 days), and at disease progression. This cohort is used to assess longitudinal imaging changes and their relationship with treatment response.
- interventionNames
- Drug: 18F-FDG
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.