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

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ClinicalTrials.gov Identifier: NCT03790423
Recruitment Status : Recruiting
First Posted : December 31, 2018
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Malene Martini Clausen, Rigshospitalet, Denmark

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).


Condition or disease Intervention/treatment Phase
Breast Cancer Lung Cancer Pancreatic Cancer Ovarian Cancer Cervix Cancer Drug: Injection of 18F-ASIS Other: PET/CT scan Phase 1

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase I: PET Imaging of Tissue Factor (TF) Expression in Patients With Primary and Metastastic Cancer Using 18F-ASIS.
Actual Study Start Date : January 3, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


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
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




Primary Outcome Measures :
  1. 1.Biodistribution of the radiotracer 18F-ASIS estimated by PET [ Time Frame: 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. 2.Dosimetry of the radiotracer 18F-ASIS estimated by PET [ Time Frame: 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. 3. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 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 Outcome Measures :
  1. 1.Quantitative uptake of the radiotracer 18F-ASIS in tumor tissue [ Time Frame: 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03790423


Contacts
Contact: Andreas Kjær, MD, PhD +4535454011 andreas.kjaer@regionh.dk
Contact: Mathias D Loft, MD +4535458266 mathias.dyrberg.loft@regionh.dk

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Andreas Kjaer, MD    +4535454011    andreas.kjaer@regionh.dk   
Contact: Mathias D Loft, MD    +4535458266    mathias.dyrberg.loft@regionh.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Malene M Clausen, MD, PhD Rigshospitalet, Denmark

Responsible Party: Malene Martini Clausen, Principal Investigator, MD, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03790423     History of Changes
Other Study ID Numbers: AK2018_1
2015-005583-42 ( EudraCT Number )
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pancreatic Neoplasms
Uterine Cervical Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Thromboplastin
Hemostatics
Coagulants