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

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT03278275
Collaborator
(none)
116
Enrollment
1
Location
1
Arm
44.2
Actual Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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
  • 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)

Study Design

Study Type:
Interventional
Actual Enrollment :
116 participants
Allocation:
N/A
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 :
Nov 1, 2017
Actual Primary Completion Date :
Jul 8, 2021
Actual Study Completion Date :
Jul 8, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. uPAR PET/CT imaging of patients with neuroendocrine tumors [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 [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Copenhagen Denmark 2100

Sponsors and Collaborators

  • Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Esben Carlsen, MD, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Esben Carlsen, Principle investigator, Medical doctor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT03278275
Other Study ID Numbers:
  • AK2017-1
  • 2017-002312-13
First Posted:
Sep 11, 2017
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Esben Carlsen, Principle investigator, Medical doctor, Rigshospitalet, Denmark
urokinase plasminogen activator receptor
uPAR PET/CT
positron emission tomography
neuroendocrine tumors
Additional relevant MeSH terms:
Neuroendocrine Tumors

Study Results

No Results Posted as of Jun 30, 2022