Back to resultsPET/CT Imaging of uPAR-expression in Patients With Neuroendocrine Tumors Using 68Ga-NOTA-AE105
Primary Purpose
Neuroendocrine Tumors
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
One injection of 68Ga-NOTA-AE105
PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Neuroendocrine Tumors focused on measuring urokinase plasminogen activator receptor, uPAR PET/CT, positron emission tomography, neuroendocrine tumors
Eligibility 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)
Sites / Locations
- Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
uPAR PET/CT
Arm Description
One injection of the radioligand 68Ga-NOTA-AE105
Outcomes
Primary Outcome Measures
uPAR PET/CT imaging of patients with neuroendocrine tumors
The radioligand 68Ga-NOTA-AE105 can be used to visualize neuroendocrine tumors (grade G1-G3)
Secondary Outcome Measures
uPAR PET/CT prognostic factor for progression free survival
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)
uPAR PET/CT prognostic factor for overall and disease specific survival
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)
Full Information
NCT ID
NCT03278275
First Posted
September 8, 2017
Last Updated
June 28, 2022
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT03278275
Brief Title
PET/CT Imaging of uPAR-expression in Patients With Neuroendocrine Tumors Using 68Ga-NOTA-AE105
Official Title
PET/CT Imaging of uPAR-expression in Patients With Neuroendocrine Tumors Using 68Ga-NOTA-AE105
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
July 8, 2021 (Actual)
Study Completion Date
July 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
Keywords
urokinase plasminogen activator receptor, uPAR PET/CT, positron emission tomography, neuroendocrine tumors
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
uPAR PET/CT
Arm Type
Experimental
Arm Description
One injection of the radioligand 68Ga-NOTA-AE105
Intervention Type
Drug
Intervention Name(s)
One injection of 68Ga-NOTA-AE105
Intervention Description
One injection of 68Ga-NORA-AE105
Intervention Type
Device
Intervention Name(s)
PET/CT
Intervention Description
Following injection of 68Ga-NOTA-AE105 the participants will be subjected to whole body PET/CT
Primary Outcome Measure Information:
Title
uPAR PET/CT imaging of patients with neuroendocrine tumors
Description
The radioligand 68Ga-NOTA-AE105 can be used to visualize neuroendocrine tumors (grade G1-G3)
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
uPAR PET/CT prognostic factor for progression free survival
Description
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)
Time Frame
12 months
Title
uPAR PET/CT prognostic factor for overall and disease specific survival
Description
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)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esben Carlsen, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
PET/CT Imaging of uPAR-expression in Patients With Neuroendocrine Tumors Using 68Ga-NOTA-AE105
We'll reach out to this number within 24 hrs