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

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ClinicalTrials.gov Identifier: NCT03505346
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Simon Bentsen, Rigshospitalet, Denmark

Brief Summary:
The aim is to examine the expression of αvβ3 integrin using a novel selective radiotracer in patients with chronich ischemic heart disease and investigate if it is a suitable tool for predicting myocardial recovery and thus prognosis after intervention.

Condition or disease Intervention/treatment Phase
Chronic Ischemic Heart Disease Drug: 68Ga-NODAGA-E[c(RGDyK)]2 Phase 2

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. Ischemic heart disease is most commently caused by arteriosclerosis of the coronary artery.

If chronic ischemic heart disease is left untreated, it will lead to symptoms to the patient. These symptons occur when the myocardiel oxygen demand exceeds the oxygen provided, due to coronary occlusion.

If the heart suffers from ischemia, 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.

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 before interventions may correlate to recovery of cardiac function and thus serve as a prognostic marker after intervention.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 68 Ga-NODAGA-E[c(RGDγK)]2: Positron Emission Tomography Tracer for Imaging of Angiogenesis in Ischemic Heart Disease
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: percutanous coronary intervention(PCI)
200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV. two times. 14-21 days before 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 Name: RGD-PET

Experimental: Coronary artery bypass-graft(CABG)
200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV. two times. 14-21 days before intervention and 30-35 days after interventionintervention
Drug: 68Ga-NODAGA-E[c(RGDyK)]2
200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV.
Other Name: RGD-PET




Primary Outcome Measures :
  1. To evaluate myocardial angiogenesis [ Time Frame: 30-35 days ]
    Analysing change in uptake of 68Ga-NODAGA-E[c(RGDyK)]2 Positron Emission Tomography after intervention


Secondary Outcome Measures :
  1. Correlation between 68Ga-NODAGA-E[c(RGDyK)]2 and myocardial perfusion [ Time Frame: 30-35 days ]
    Correlation between uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and change in myocardial perfusion after intervention using Rubidium 82 Positron Emission Tomography

  2. Correlation between 68Ga-NODAGA-E[c(RGDyK)]2 and functional recovery [ Time Frame: 30-35 days ]
    Correlation between uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and functional recovery using Magnetic Resonance after intervention

  3. Correlatino between 68Ga-NODAGA-E[c(RGDyK)]2 and viability [ Time Frame: 30-35 days ]
    Correlation between uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and viability using Flour-Deoxy-Glucose Positron Emission Tomography after intervention



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age over 50 years
  • Patient with known chornic ischemic Heart disease admitted to Rigshospitalet to either PCI og CABG

Exclusion Criteria:

  • 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)
  • Conversion from PCI to CABG
  • 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¨
  • Type I or II diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505346


Contacts
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Contact: Simon Bentsen, MD +4535451793 simon.bentsen.01@regionh.dk
Contact: Rasmus Ripa, MD +4535454011 rasmus.ripa@regionh.dk

Locations
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Denmark
Department of Physiology, Nuclear Medicine and PET Recruiting
Copenhagen, Region Hovedstaden, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Study Director: Andreas Kjær, MD Rigshospitalet, Denmark

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Responsible Party: Simon Bentsen, Medical doctor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03505346     History of Changes
Other Study ID Numbers: EUDRA-CT: 2017-002712-14
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Simon Bentsen, Rigshospitalet, Denmark:
Positron Emission Tomography
nuclear medicine
prognosis

Additional relevant MeSH terms:
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Ischemia
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases