18F-ASIS PET/CT Imaging of Tissue Factor Expression In Patients With Primary and Metastastic Cancer

Breast Cancer Clinical Trial

Official title:

Phase I: PET Imaging of Tissue Factor (TF) Expression in Patients With Primary and Metastastic Cancer Using 18F-ASIS.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03790423
• Other study ID #: AK2018_1
• Secondary ID: 2015-005583-42
• Status: Completed
• Phase: Phase 1
• Start date: January 3, 2019
• Est. completion date: November 18, 2019

Study information

• Verified date: November 2020
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 18, 2019
• Est. primary completion date: November 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Cervix Cancer
• Lung Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Injection of 18F-ASIS
Each patient will receive one injection of 18F-ASIS (approximately 200 Mbq)

Other:
• PET/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

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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