Breast Cancer, Cervix Cancer, Lung Cancer, Ovarian Cancer, Pancreatic Cancer
Conditions
Brief summary
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).
Detailed description
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). The primary end points are safety, biodistribution and dosimetry of 18F-ASIS. In addition, the quantitative uptake of 18F-ASIS will be compared to the expression of TF measured directly in tumor tissue obtained by surgery or biopsies. The study will be monitored and evaluated in accordance with the principles of Good Clinical Practice (GCP).
Interventions
DRUGInjection of 18F-ASIS
Each patient will receive one injection of 18F-ASIS (approximately 200 Mbq)
OTHERPET/CT scan
Following one injection of 18F-ASIS the patients will be PET/CT scanned at 1 hour, 2 hours and 4 hours post-injection
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1.Biodistribution of the radiotracer 18F-ASIS estimated by PET | 4 hours | 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 |
| 2.Dosimetry of the radiotracer 18F-ASIS estimated by PET | 4 hours | Dosimetry will be calculated with the use of OLINDA/EXM software (mSv) based on repeated PET imaging with the radiotracer 18F-ASIS |
| 3. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 48 hours | The safety of 18F-ASIS PET as measured by the number of participants with adverse events within 48 hours following the 18F-ASIS PET assessed by CTCAE v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1.Quantitative uptake of the radiotracer 18F-ASIS in tumor tissue | 4 hours | The patients will be PET scanned 1 hour, 2 hours and 4 hours post-injection of the radiotracer 18F-ASIS. These timepoints will be used for assessment of tumor uptake by the use of maximum and mean standardized uptake value (SUV). |
Countries
Denmark
Outcome results
None listed