PET/CT Imaging of uPAR-expression in Patients With Neuroendocrine Tumors Using 68Ga-NOTA-AE105

NCT ID: NCT03278275

Last Updated: 2022-06-30

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

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2021-07-08

Brief Summary

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The aim of this non-randomised, prospective study is to investigate the applicability and prognostic value of uPAR PET/CT with the radioligand 68Ga-NOTA-AE105 in patients with neuroendocrine tumors (NETs).

Detailed Description

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68Ga-NOTA-AE105 is a radioligand targeting urokinase plasminogen activator receptor (uPAR), which is a promising imaging biomarker of tumor aggressiveness. A total of 120 NET patients will be subjected to a uPAR-PET/CT scan. Follow-up will be performed (from the time of the angiogenesis PET/ CT) at 6 months for disease specific survival (DSS) and a 1 year follow-up for PFS and OS. The uptake of 68Ga-NOTA-AE105 in tumor lesions will be quantified as Standardized Uptake Values (SUVmax/SUVmean) and compared with PFS, DSS and OS (dichotomized above/below median SUVmax and analyzed by Kaplan-Meier)

Conditions

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Neuroendocrine Tumors

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/CT

One injection of the radioligand 68Ga-NOTA-AE105

Group Type EXPERIMENTAL

One injection of 68Ga-NOTA-AE105

Intervention Type DRUG

One injection of 68Ga-NORA-AE105

PET/CT

Intervention Type DEVICE

Following injection of 68Ga-NOTA-AE105 the participants will be subjected to whole body PET/CT

Interventions

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One injection of 68Ga-NOTA-AE105

One injection of 68Ga-NORA-AE105

Intervention Type DRUG

PET/CT

Following injection of 68Ga-NOTA-AE105 the participants will be subjected to whole body PET/CT

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with gastro-entero-pancreatic Neuroendocrine Tumors (GEP-NET; grade: G1-G3) or broncho-pulmonary NET.
* WHO performance status 0-2
* Must be able to read and understand the patient information in Danish and to give informed consent

Exclusion Criteria

* Pregnancy
* Breast-feeding
* Weight more than the maximum weight limit for the PET/CT bed of the scanner (140 kg)
* History of allergic reaction attributable to compounds of similar chemical or biologic composition to 68Ga-NODAGA-E\[c(RGDyK)\]2
* In case of broncho-pulmonary NET, the subtype must not be small cell lung cancer (SCLC)
Minimum Eligible Age

18 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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Esben Carlsen

Principle investigator, Medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Esben Carlsen, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2017-002312-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AK2017-1

Identifier Type: -

Identifier Source: org_study_id

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