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

June 28, 2022 updated by: Esben Carlsen, Rigshospitalet, Denmark
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

113

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 months
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)
12 months
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)
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2017

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

August 31, 2017

First Submitted That Met QC Criteria

August 31, 2017

First Posted (Actual)

September 5, 2017

Study Record Updates

Last Update Posted (Actual)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 28, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK2017-2
  • 2017-002512-14 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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