Clinical trial · Interventional
18F-ASIS PET/CT Imaging of Tissue Factor Expression In Patients With Primary and Metastastic Cancer
Phase I: PET Imaging of Tissue Factor (TF) Expression in Patients With Primary and Metastastic Cancer Using 18F-ASIS.
- 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 primary objective of the trial is to test the new radio tracer 18F-ASIS for PET imaging of tissue factor (TF) expression. The tracer has the potential of identifying tumors with high levels of TF expression, which is expected to correlate with tumor aggression and prognosis. Furthermore, the tracer can potentially be used as companion imaging diagnostic agent for identifying patients eligible for TF directed therapies. This is a first-in-man study to test the radio tracer in cancer patients. Safety, biodistribution and dosimetry will be evaluated by repeated PET imaging (1 hour, 2 hours and 4 hours post-injection).
Conditions
Conditions (5)
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 |
| Cervix Cancer | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Injection of 18F-ASIS | Drug | — | UNRESOLVED |
| PET/CT scan | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-ASIS PET
- description
- One injection of 18F-ASIS (app. 200 MBq) followed by 3 PET/CT scans 1 hour, 2 hours and 4hours post-injection
- interventionNames
- Drug: Injection of 18F-ASIS
- Other: PET/CT scan
Primary outcomes (3)
- measure
- 1.Biodistribution of the radiotracer 18F-ASIS estimated by PET
- timeFrame
- 4 hours
- description
- The biodistribution of the 18F-ASIS radiotracer estimated from the standardized uptake values (SUV) of the major organs obtained from the patient's repeated PET imaging with the radiotracer 18F-ASIS
- measure
- 2.Dosimetry of the radiotracer 18F-ASIS estimated by PET
- timeFrame
- 4 hours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with breast, lung, pancreatic, cervix or ovarian cancer * Capable of understanding the patient information in Danish and giving full informed consent Exclusion Criteria: * Pregnancy * Breast-feeding * Weight above 140 kg * History of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-ASIS
References
Publications (0)
Data not yet available