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Trial record 9 of 2831 for:    tumor | Neuroendocrine Tumors

PET/CT Imaging of Angiogenesis in Patients With Neuroendocrine Tumors Using 68Ga-NODAGA-E[c(RGDyK)]2

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ClinicalTrials.gov Identifier: NCT03271281
Recruitment Status : Recruiting
First Posted : September 5, 2017
Last Update Posted : May 15, 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 angiogenesis PET/CT with the radioligand 68Ga-NODAGA- E[c(RGDyK)]2 in patients with neuroendocrine tumors (NETs).

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: One injection of 68Ga-NODAGA-E[c(RGDyK)]2 Device: PET/CT Phase 2

Detailed Description:

The radioligand 68Ga-NODAGA- E[c(RGDyK)]2 targets the Arg-Gly-Asp (RGD) sequence known to bind with the αvβ3 integrin that is expressed on the surface of angiogenic blood vessels or tumor cells. The radioligand can be used to visualize tumor angiogenesis using PET/CT.

A total of 120 NET patients will be subjected to an angiogenesis-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-NODAGA-E[c(RGDyK)]2 (Standardized Uptake Values, SUVmax) 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 Angiogenesis in Patients With Neuroendocrine Tumors Using 68Ga-NODAGA-E[c(RGDyK)]2
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: Experimental: Angiogenesis PET/CT
One injection of the radioligand 68Ga-NODAGA-E[c(RGDyK)]2 followed by PET/CT
Drug: One injection of 68Ga-NODAGA-E[c(RGDyK)]2
One injection of 68Ga-NODAGA-E[c(RGDyK)]2

Device: PET/CT
Following injection of 68Ga-NODAGA-E[c(RGDyK)]2 the patients will be subjected to whole body PET/CT




Primary Outcome Measures :
  1. Angiogenesis PET/CT imaging of patients with neuroendocrine tumors [ Time Frame: 1 hour ]
    The radioligand 68Ga-NODAGA-E[c(RGDyK)]2 can be used to visualize neuroendocrine tumors (grade G1-G3)


Secondary Outcome Measures :
  1. Angiogenesis PET/CT progonostic factor for progression free survival [ Time Frame: 12 months ]
    The uptake of the 68Ga-NODAGA-E[c(RGDyK)]2 in neuroendocrine tumor lesions (quantified as Standard Uptake Values) is associated with progression free survival (PFS) neuroendocrine tumors (grade G1-G3)

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

  3. Target validation of angiogenesis PET/CT [ Time Frame: 2 weeks ]
    Uptake of 68Ga-NODAGA-E[c(RGDyK)]2 correlates directly to gene expression of angiogenesis markers αvβ3 integrin and VEGF-A in tumor tissue obtained by biopsies or planned surgery (<2 weeks before/after angiogenesis PET/CT)



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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): NCT03271281


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

Locations
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Denmark
Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Esben Carlsen, MD    +4535454011    esben.andreas.carlsen.01@regionh.dk   
Contact: Andreas Kjær    +4535454011    andreas.kjaer@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, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03271281     History of Changes
Other Study ID Numbers: AK2017-2
2017-002512-14 ( EudraCT Number )
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: May 15, 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:
68Ga-NODAGA-E[c(RGDyK)]2
Angiogenesis PET/CT
Neuroendocrine tumors
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue