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

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT03271281
Collaborator
(none)
113
1
1
48.9
2.3

Study Details

Study Description

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
  • 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).

Study Design

Study Type:
Interventional
Actual Enrollment :
113 participants
Allocation:
N/A
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 :
Dec 4, 2017
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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

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, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT03271281
Other Study ID Numbers:
  • AK2017-2
  • 2017-002512-14
First Posted:
Sep 5, 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, MD, Rigshospitalet, Denmark
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 30, 2022