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68Ga-DFC413 · 1 trial · 7 indications
Imaging properties of 68Ga-DFC413 will be evaluated by assessing radiotracer uptake, identified via positron emission tomography (PET) scans. The SUV values will be calculated and reported with summary statistics.
SUVr will be calculated by dividing the SUV of the lesions by the SUV of the different organs in order to identify the reference organ with the lowest uptake and the respective SUVr (i.e. using SUVmean or SUVmax).
Agreement between target lesions and normal organs from 68Ga-DFC413 and 68Ga-NNS309 PET imaging will be assessed using summary statistics of SUV and SUVr.
| Arm | Type | Description |
|---|---|---|
| Part 1: Imaging Characterization | EXPERIMENTAL | Single dose of 68Ga-DFC413 |
| Part 2: Comparative Assessment | EXPERIMENTAL | Single dose of 68Ga-DFC413 followed by 68Ga-NNS309; or single dose of 68Ga-NNS309 followed by 68Ga-DFC413 |
| Name | Type | Description |
|---|---|---|
| 68Ga-DFC413 | DRUG | Radioimaging agent |
| 68Ga-NNS309 | DRUG | Radioimaging agent |
Inclusion Criteria: Patients eligible for inclusion in this study must meet all of the following criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Age ≥ 18 years old. 3. ECOG performance status ≤ 2. 4. Patients with one of the following indications (rega...
68Ga-DFC413 is an investigational small molecule being studied for use in metastatic pancreatic ductal adenocarcinoma (PDAC), as well as other solid tumors including non-small cell lung cancer, breast cancer subtypes, colorectal cancer, and soft tissue sarcoma. It is currently in Phase 1 clinical development.
68Ga-DFC413 is a gallium-68 labeled small molecule. The specific molecular target has not been disclosed in the available clinical trial information. It is being evaluated as a diagnostic imaging agent in a Phase 1 study.
68Ga-DFC413 is being developed by Novartis AG, which trades under the ticker symbol NVS. The company is conducting a Phase 1 clinical trial of the agent in patients with solid tumors.
68Ga-DFC413 is in Phase 1 clinical development. It is an investigational agent and has not been approved by regulatory authorities. A single Phase 1 trial is currently recruiting participants.
68Ga-DFC413 is being studied in a Phase 1 trial with the identifier NCT07630961. The trial is recruiting 66 participants and is being conducted in Denmark and Japan. It is comparing 68Ga-DFC413 to another investigational agent in patients with various solid tumors.
68Ga-DFC413 is also referred to as JFI447 in the clinical trial title. The study is described as a Phase I study of JFI447 [68Ga]Ga-DFC413, indicating that JFI447 is another name for this investigational agent.