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Evaluation of a New Radiotracer (64Cu-DOTA-AE105) for Diagnosing Aggressive Cancer With Positron Emission Tomography

NCT ID: NCT02139371

Last Updated: 2014-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-10-31

Brief Summary

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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).

Detailed Description

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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). The primary end points are Biodistribution and dosimetry of 64Cu-DOTA-AE105. In addition, the quantitative uptake of 64Cu-DOTA-AE105 in tumors and expression of uPAR in tumor tissue obtained by surgery or biopsies (either 14 days before (only biopsies) or after the PET scans) will be compared to validate the image-derived data on UPAR expression

Conditions

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Breast Cancer Prostate Cancer Urinary Bladder Cancer

Keywords

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Positron Emission Tomography Uroplasminogen Plasminogen Activator Receptor Breast cancer Prostate cancer Urinary bladder cancer Biodistribution Radiation exposure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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64Cu-DOTA-AE105 PET

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

Group Type EXPERIMENTAL

Injection of 64Cu-DOTA-AE105

Intervention Type OTHER

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

Interventions

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Injection of 64Cu-DOTA-AE105

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Dorthe Skovgaard

MD, Phd

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dorthe Skovgaard, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet

Copenhagen, Copenhagen, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 22213823 (View on PubMed)

Other Identifiers

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2013-574

Identifier Type: -

Identifier Source: org_study_id