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

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT03790423
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
10.5
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
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 :
Jan 3, 2019
Actual Primary Completion Date :
Nov 18, 2019
Actual Study Completion Date :
Nov 18, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 1.Biodistribution of the radiotracer 18F-ASIS estimated by PET [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 [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] [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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rigshospitalet Copenhagen Denmark 2100

Sponsors and Collaborators

  • Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Mathias D Loft, MD, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mathias Dyrberg Loft, Principal Investigator, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT03790423
Other Study ID Numbers:
  • AK2018_1
  • 2015-005583-42
First Posted:
Dec 31, 2018
Last Update Posted:
Nov 19, 2020
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Uterine Cervical Neoplasms

Study Results

No Results Posted as of Nov 19, 2020