uPAR PET/CT for Preoperative Staging of Breast Cancer Patients

NCT ID: NCT02681640

Last Updated: 2017-04-06

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

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-03-31

Brief Summary

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The sensitivity and specificity of uPAR PET/CT for preoperative detection of lymph node metastases in breast cancer.

Detailed Description

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The sensitivity and specificity of uPAR PET/CT for detection of lymph node metastases will be tested by observer-blinded readings (two separate teams) and compared to diagnostic performance of conventional preoperative diagnostic workup procedures. The reference test will be histopathology of lymph nodes obtained by operative lymph node dissection (SN/ALND). Primary end point dichotomized: +/- lymph node metastases in ipsilateral axilla.

Conditions

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Breast Cancer

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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uPAR PET

One injection of 68Ga-NOTA-AE105 followed by Positron Emission Tomography (PET/CT scan) to evaluate possible axillary lymph node metastatic lesions

Group Type EXPERIMENTAL

68Ga-NOTA-AE105

Intervention Type OTHER

One injection of 68Ga-NOTA-AE105

Positron Emission Tomography PET/CT

Intervention Type DEVICE

Following injection of 68Ga-NOTA-AE105 the patients will be subjected to Positron Emission Tomography PET/CT

Interventions

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68Ga-NOTA-AE105

One injection of 68Ga-NOTA-AE105

Intervention Type OTHER

Positron Emission Tomography PET/CT

Following injection of 68Ga-NOTA-AE105 the patients will be subjected to Positron Emission Tomography PET/CT

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Biopsy-verified breast cancer
* Primary tumor more than 2 cm (ultrasound or clinically)
* The participants must be capable of understanding and giving full informed written consent

Exclusion Criteria

* Pregnancy
* Lactation/breast feeding
* Weight above 140 kg
* Treatment with neoadjuvant chemotherapy
* Known allergy towards the IMP
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Curasight ApS

UNKNOWN

Sponsor Role collaborator

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

Other Identifiers

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CS-2015-1

Identifier Type: -

Identifier Source: org_study_id

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