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

Rigshospitalet

Status and phase: Completed; Phase 1

Conditions: Breast Cancer; Lung Cancer; Ovarian Cancer; Cervix Cancer; Pancreatic Cancer

Treatments: Drug: Injection of 18F-ASIS; Other: PET/CT scan

Study type: Interventional

Funder types: Other

Identifiers

NCT03790423

AK2018_1

2015-005583-42 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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).

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

18F-ASIS PET

Experimental group

Description:

One injection of 18F-ASIS (app. 200 MBq) followed by 3 PET/CT scans 1 hour, 2 hours and 4hours post-injection

Treatment:

Drug: Injection of 18F-ASIS

Other: PET/CT scan