- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2019-01-03
2019-11-18
2019-11-18
10
NCT03790423
Rigshospitalet, Denmark
Rigshospitalet, Denmark
INTERVENTIONAL
18F-ASIS PET/CT Imaging of Tissue Factor Expression In Patients With Primary and Metastastic Cancer
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 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).
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-12-20 | N/A | 2020-11-17 |
2018-12-28 | N/A | 2020-11-19 |
2018-12-31 | N/A | 2020-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: 18F-ASIS PET One injection of 18F-ASIS (app. 200 MBq) followed by 3 PET/CT scans 1 hour, 2 hours and 4hours post-injection | DRUG: Injection of 18F-ASIS
OTHER: PET/CT scan
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 1.Biodistribution of the radiotracer 18F-ASIS estimated by PET | 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 | 4 hours |
| 2.Dosimetry of the radiotracer 18F-ASIS estimated by PET | Dosimetry will be calculated with the use of OLINDA/EXM software (mSv) based on repeated PET imaging with the radiotracer 18F-ASIS | 4 hours |
| 3. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 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 | 48 hours |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 1.Quantitative uptake of the radiotracer 18F-ASIS in tumor tissue | 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). | 4 hours |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
