Clinical trial · Interventional
Clinical Study of TROP-2 PET/CT for Noninvasive Diagnosis of Solid Tumors
- 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)
This study will investigate the safety and preliminary diagnostic efficacy of \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 in pancreatic cancer, breast cancer, head and neck cancer, lung cancers and other types of solid tumors. Then, this study will provide a new method for the noninvasive target-specific diagnosis of pancreatic cancer, breast cancer, head and neck cancer, lung cancers and other types of solid tumors. PET imaging of TROP-2 will be integrated to TROP-2-targeted therapies in some of the included patients. Therefore, PET imaging with \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 will help select patients for targeted therapy and monitor treatment responses after the treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Positron-Emission Tomography | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- patients with solid tumors
- description
- Subjects were recruited from Huashan Hospital of Fudan University.
- interventionNames
- Radiation: [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4
Primary outcomes (3)
- measure
- evaluate the safety and feasibility of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT imaging in patients with solid tumors
- timeFrame
- 1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4
- description
- The primary goal of the study is to evaluate the distribution profiles (in terms of SUVmax) of \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 PET/CT imaging in patients with solid tumors.
- measure
- evaluate the sensitivity and specificity of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT for visualizing TROP-2 expression
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Be between 18 and 65 years of age and of either sex. 2. Patients with colorectal cancer confirmed by puncture or surgical pathology. 3. Written informed consent signed by the subject or legal guardian or caregiver. 4. Willingness and ability to cooperate with all programs of this study. Exclusion Criteria: 1. Severe hepatic or renal insufficiency; 2. Targeted therapy before radiotherapy or PET/CT scan； 3. Renal function: serum creatinine less than or equal to the upper limit of the normal range;Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range； 4. History of serious surgery in the last month. Those who have participated in other clinical trials during the same period.
References
Publications (0)
Data not yet available