68 Ga-NODAGA-E[c(RGDγK)]2: Positron Emission Tomography Tracer for Imaging of Myocardial Angiogenesis

July 13, 2020 updated by: Simon Bentsen, Rigshospitalet, Denmark

68Ga-NODAGA-E[c(RGDγK)]2: a Novel Positron Emission Tomography (PET) Tracer for in Vivo Molecular Imaging of Myocardial Angiogenesis Following Myocardial Infarction

The aim is to examine the expression of αvβ3 integrin using a novel selective radiotracer in patients with myocardial infarction and investigate if it is a suitable tool for predicting myocardial recovery and thus prognosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ischemic heart disease is worldwide the single most frequent cause of death. The number of patients surviving acute myocardial injury is increasing due to improved acute treatment. However, after the initial repair, the tissue undergoes a remodeling phase to compensate for the damaged area. This re-modeling phase can change the structure end geometry of the heart resulting in lower ejection fraction, leading to cardiac dysfunction, which eventually leads to heart failure. Understanding and ideally modifying the reparative mechanisms following myocardial infarction is increasingly important and may lead to improved outcome.

If the heart suffers from ischemia following an acute coronary event, the tissue reacts strongly to the hypoxia. The body will as a compensatory mechanism create new vessel to provide the tissue with oxygen. This is known as the biological process of angiogenesis. This complex process involves different angiogenic and pro-fibrotic transcription factors that initiate the restoration of capillaries by sprouting from the existing endothelial cells in response to hypoxia.

Time seem essential to protect and save the myocardium. An early onset of cytokines and growth factors is associated with a decline in cardiomyocytes apoptosis, smaller infarct areas, and decreased ventricular dilation. Therefore, an early induction of angiogenesis seems important for a good prognosis of the patient.

Integrin αvβ3 is a transmembrane cell surface receptor that is markedly upregulated in states of angiogenesis. It facilitates migration and proliferation and thereby allowing cells to respond to extracellular environment. Integrin αvβ3 is thus a key player in the angiogenic process. The integrin αvβ3 has a binding site for an RGD peptide (Arg-Gly-Asp motif) and this can be targeted by PET tracers.

RGD-based PET tracers have been shown to accumulate at the site of myocardial necrosis in both human and animal studies. The uptake seems to peak a few weeks after the infarction and may correlate to recovery of cardiac function and thus serve as a prognostic marker.

Study Type

Interventional

Enrollment (Actual)

42

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
    • Region Hovedstaden
      • Copenhagen, Region Hovedstaden, Denmark, 2100
        • Department of Physiology, Nuclear Medicine and PET

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age over 50 years

Acute myocardial infarction Group:

  • Verified first-time acute myocardial infarction treated with PCI

Control Group:

  • Previous healthy
  • No known cardiac disease

Exclusion Criteria:

  • No prior history of acute coronary infarction
  • No prior history of Heart surgery
  • Not treated with anti-angiogenic medicine
  • Subject with pacemaker, cochlear implant or insulin pump
  • Pregnancy
  • Lactation
  • Severe claustrophobia
  • Severe obesity (weight above 140kg)
  • If a subject is in the fertile age, a pregnancy test will be use prior to injection to the PET_tracer
  • If a subject is having a severe allergic reaction to the PET-tracer, the person will be excluded for the rest of the trial
  • If the PET-tracer is administered subcutaneous, the person will be excluded for the rest of the trial¨
  • Tupe I or II diabetes

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: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acute myocardial infarctions group
200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV. three times. 1-3 days after intervention, 7-10 days after intervention and 30-35 days after intervention.
Drug: 68Ga-NODAGA-E[c(RGDyK)]2
200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV.
Other Names:
  • RGD-PET
Active Comparator: Control group
200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV. one time.
Drug: 68Ga-NODAGA-E[c(RGDyK)]2
200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV.
Other Names:
  • RGD-PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate myocardial angiogenesis
Time Frame: 30-35 days
Analysing uptake of 68Ga-NODAGA-E[c(RGDyK)]2 Positron Emission Tomography in myocardial infarction after PCI
30-35 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and myocardial perfusion
Time Frame: 30-35 days
Quantitative uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and change in myocardial perfusion after PCI using Rubidium 82 Positron Emission Tomography after Percutaneous coronary intervention(PCI)
30-35 days
Uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and functional recovery
Time Frame: 30-35 days
Quantitative uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and functional recovery using Magnetic Resonance after PCI
30-35 days
Uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and viability
Time Frame: 30-35 days
Quantitative uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and viability using Flour-Deoxy-Glucose Positron Emission Tomography after PCI
30-35 days

Collaborators and Investigators

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

Sponsor

Rigshospitalet, Denmark

Investigators

  • Study Director: Andreas Kjær, 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)

February 20, 2018

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

February 18, 2018

First Submitted That Met QC Criteria

February 22, 2018

First Posted (Actual)

February 26, 2018

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUDRACR-number: 2017-002709-36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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