Clinical trial NCT03790423: 18F-ASIS PET/CT Imaging of Tissue Factor Expression In Patients With Primary and Metastastic Cancer
Official title: Phase I: PET Imaging of Tissue Factor (TF) Expression in Patients With Primary and Metastastic Cancer Using 18F-ASIS.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Lung Cancer
Pancreatic Cancer
Ovarian Cancer
Cervix Cancer
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2018-12-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

Eligibility criteria: 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

Primary outcomes:
measure: 1.Biodistribution of the radiotracer 18F-ASIS estimated by PET
timeFrame: 4 hours
measure: 2.Dosimetry of the radiotracer 18F-ASIS estimated by PET
timeFrame: 4 hours
measure: 3. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 48 hours
Secondary outcomes:
measure: 1.Quantitative uptake of the radiotracer 18F-ASIS in tumor tissue
timeFrame: 4 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Mathias D Loft, MD
role: PRINCIPAL_INVESTIGATOR
References: