NCT03271281

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2017

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

December 4, 2017

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

4.1 years

First QC Date

August 31, 2017

Last Update Submit

June 28, 2022

Conditions

Neuroendocrine Tumors

Keywords

68Ga-NODAGA-E[c(RGDyK)]2Angiogenesis PET/CTNeuroendocrine tumors

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Angiogenesis PET/CT progonostic factor for progression free survival

    12 months

  • Angiogenesis PET/CT prognostic factor for overall and disease specific survival

    12 months

  • Target validation of angiogenesis PET/CT

    2 weeks

Study Arms (1)

Experimental: Angiogenesis PET/CT

EXPERIMENTAL

One injection of the radioligand 68Ga-NODAGA-E\[c(RGDyK)\]2 followed by PET/CT

Drug: One injection of 68Ga-NODAGA-E[c(RGDyK)]2Device: PET/CT

Interventions

One injection of 68Ga-NODAGA-E[c(RGDyK)]2DRUG

One injection of 68Ga-NODAGA-E\[c(RGDyK)\]2

Experimental: Angiogenesis PET/CT
PET/CTDEVICE

Following injection of 68Ga-NODAGA-E\[c(RGDyK)\]2 the patients will be subjected to whole body PET/CT

Experimental: Angiogenesis PET/CT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Esben Carlsen, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 5, 2017

Study Start

December 4, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

June 30, 2022

Record last verified: 2022-06

Locations

DK(1)