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Trial record 15 of 2732 for:    Neoplasms | Neuroendocrine Tumors

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

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ClinicalTrials.gov Identifier: NCT03278275
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Esben Carlsen, Rigshospitalet, Denmark

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: One injection of 68Ga-NOTA-AE105 Device: PET/CT Phase 2

Detailed Description:
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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PET/CT Imaging of uPAR-expression in Patients With Neuroendocrine Tumors Using 68Ga-NOTA-AE105
Actual Study Start Date : November 20, 2017
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: uPAR PET/CT
One injection of the radioligand 68Ga-NOTA-AE105
Drug: One injection of 68Ga-NOTA-AE105
One injection of 68Ga-NORA-AE105

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




Primary Outcome Measures :
  1. uPAR PET/CT imaging of patients with neuroendocrine tumors [ Time Frame: 1 hour ]
    The radioligand 68Ga-NOTA-AE105 can be used to visualize neuroendocrine tumors (grade G1-G3)


Secondary Outcome Measures :
  1. uPAR PET/CT prognostic factor for progression free survival [ Time Frame: 12 months ]
    The uptake of the 68Ga-NOTA-AE105 in neuroendocrine tumor lesions (quantified as Standard Uptake Values) is associated with progression free survival (PFS) neuroendocrine tumors (grade G1-G3)

  2. uPAR PET/CT prognostic factor for overall and disease specific survival [ Time Frame: 12 months ]
    The uptake of the 68Ga-NOTA-AE105 in neuroendocrine tumor lesions (quantified as Standard Uptake Values) is associated with overall and disease specific free survival (PFS) neuroendocrine tumors (grade G1-G3)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278275


Contacts
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Contact: Esben Carlsen, MD +45354011 esben.andreas.carlsen.01@regionh.dk
Contact: Andreas Kjaer, Professor +4535454011 andreas.kjaer@regionh.dk

Locations
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Denmark
Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Esben Carlsen, MD    +4535454011    esben.andreas.carlsen.01@regionh.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Esben Carlsen, MD Rigshospitalet, Denmark

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Responsible Party: Esben Carlsen, Principle investigator, Medical doctor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03278275     History of Changes
Other Study ID Numbers: AK2017-1
2017-002312-13 ( EudraCT Number )
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Esben Carlsen, Rigshospitalet, Denmark:
urokinase plasminogen activator receptor
uPAR PET/CT
positron emission tomography
neuroendocrine tumors

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue