NCT03790423

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 breast-cancer

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 31, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

January 3, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2019

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

11 months

First QC Date

December 20, 2018

Last Update Submit

November 17, 2020

Conditions

Breast CancerLung CancerPancreatic CancerOvarian CancerCervix Cancer

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (1)

  • 1.Quantitative uptake of the radiotracer 18F-ASIS in tumor tissue

    4 hours

Study Arms (1)

18F-ASIS PET

EXPERIMENTAL

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-ASISOther: PET/CT scan

Interventions

Injection of 18F-ASISDRUG

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

18F-ASIS PET
PET/CT scanOTHER

Following one injection of 18F-ASIS the patients will be PET/CT scanned at 1 hour, 2 hours and 4 hours post-injection

18F-ASIS PET

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with breast, lung, pancreatic, cervix or ovarian cancer
  • Capable of understanding the patient information in Danish and giving full informed consent

You may not qualify if:

  • Pregnancy
  • Breast-feeding
  • Weight above 140 kg
  • History of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-ASIS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Breast NeoplasmsLung NeoplasmsPancreatic NeoplasmsOvarian NeoplasmsUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesDigestive System NeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesGonadal DisordersUterine NeoplasmsUterine Cervical DiseasesUterine Diseases

Study Officials

  • Mathias D Loft, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD

Study Record Dates

First Submitted

December 20, 2018

First Posted

December 31, 2018

Study Start

January 3, 2019

Primary Completion

November 18, 2019

Study Completion

November 18, 2019

Last Updated

November 19, 2020

Record last verified: 2020-11

Locations

DK(1)