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NCT03271281 Clinical Trial

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

Neuroendocrine Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03271281
Other study ID # AK2017-2
Secondary ID 2017-002512-14
Status Completed
Phase Phase 2
First received
Last updated
Start date December 4, 2017
Est. completion date December 31, 2021

Study information
Verified date June 2022
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility
Status Completed
Enrollment 113
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Denmark Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Angiogenesis PET/CT imaging of patients with neuroendocrine tumors The radioligand 68Ga-NODAGA-E[c(RGDyK)]2 can be used to visualize neuroendocrine tumors (grade G1-G3) 1 hour
Secondary Angiogenesis PET/CT progonostic factor for progression free survival 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) 12 months
Secondary Angiogenesis PET/CT prognostic factor for overall and disease specific survival 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) 12 months
Secondary Target validation of angiogenesis PET/CT Uptake of 68Ga-NODAGA-E[c(RGDyK)]2 correlates directly to gene expression of angiogenesis markers avß3 integrin and VEGF-A in tumor tissue obtained by biopsies or planned surgery (<2 weeks before/after angiogenesis PET/CT) 2 weeks
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