NCT02139371

Brief Summary

The primary objective of the study is to test a new radiotracer called 64Cu-DOTA-AE105 for PET imaging of uPAR (urokinase plasminogen activator receptor). The tracer has the potential of identifying the invasive cancer phenotype, thereby distinguishing between aggressive and less aggressive tumors. This is a first in human study to test the radiotracer in cancer patients. The biodistribution and tumor uptake will be evaluated by repeated PET imaging (1,3 and 24 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 early_phase_1 breast-cancer

Timeline
Completed

Started May 2014

Shorter than P25 for early_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

Study Start

First participant enrolled

May 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 12, 2014

Status Verified

December 1, 2014

Enrollment Period

5 months

First QC Date

May 12, 2014

Last Update Submit

December 11, 2014

Conditions

Breast CancerProstate CancerUrinary Bladder Cancer

Keywords

Positron Emission TomographyUroplasminogen Plasminogen Activator ReceptorBreast cancerProstate cancerUrinary bladder cancerBiodistributionRadiation exposure

Outcome Measures

Primary Outcomes (2)

  • Biodistribution

    The patients will be PET scanned 1, 3 and 24 hours post injection of the radiotracer 64Cu-DOTA-AE105. These different timepoints will be used for assessment of biodistribution

    24 hours

  • Dosimetry

    The patients will be PET scanned 1, 3 and 24 hours post injection of the radiotracer 64Cu-DOTA-AE105. These different timepoints will be used for calculation of dosimetry

    24 hours

Secondary Outcomes (2)

  • Expression of UPAR in tumor tissue

    24 hours

  • Quantitative uptake of UPAR in tumor tissue

    24 hours

Study Arms (1)

64Cu-DOTA-AE105 PET

EXPERIMENTAL

One injection of 64-Cu-DOTA-AE105 (app. 200 Mbq IV) followed by 3 PET scans 1,3 and 24 hours post injection

Other: Injection of 64Cu-DOTA-AE105

Interventions

Injection of 64Cu-DOTA-AE105OTHER

One injection of 64Cu-DOTA-AE105 (app. 200 Mbq) followed by Positron Emission Tomography Scan 1, 3 and 24 hours post injection

64Cu-DOTA-AE105 PET

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of cancer of prostate, breast or urinary bladder
  • capable of understanding and giving full informed consent

You may not qualify if:

  • pregnancy
  • lactation
  • contraindication for the use of intravenous CT contrast-agencies
  • claustrophobia
  • other current/or former diagnosed cancers, except non melanoma skin cancer or carcinoma in situ cervicis uteri

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet

Copenhagen, Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • Persson M, Madsen J, Ostergaard S, Jensen MM, Jorgensen JT, Juhl K, Lehmann C, Ploug M, Kjaer A. Quantitative PET of human urokinase-type plasminogen activator receptor with 64Cu-DOTA-AE105: implications for visualizing cancer invasion. J Nucl Med. 2012 Jan;53(1):138-45. doi: 10.2967/jnumed.110.083386.

    PMID: 22213823BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsProstatic NeoplasmsUrinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesUrologic NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrinary Bladder DiseasesUrologic Diseases

Study Officials

  • Dorthe Skovgaard, MD, Phd

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 12, 2014

First Posted

May 15, 2014

Study Start

May 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

December 12, 2014

Record last verified: 2014-12

Locations

DK(1)