68 Ga-NODAGA-E[c(RGDγK)]2: Positron Emission Tomography Tracer for Imaging of Myocardial Angiogenesis
68Ga-NODAGA-E[c(RGDγK)]2: a Novel Positron Emission Tomography (PET) Tracer for in Vivo Molecular Imaging of Myocardial Angiogenesis Following Myocardial Infarction
1 other identifier
interventional
42
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2018
1 active site
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
February 18, 2018
CompletedStudy Start
First participant enrolled
February 20, 2018
CompletedFirst Posted
Study publicly available on registry
February 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedJuly 14, 2020
July 1, 2020
2.4 years
February 18, 2018
July 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate myocardial angiogenesis
Analysing uptake of 68Ga-NODAGA-E\[c(RGDyK)\]2 Positron Emission Tomography in myocardial infarction after PCI
30-35 days
Secondary Outcomes (3)
Uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and myocardial perfusion
30-35 days
Uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and functional recovery
30-35 days
Uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and viability
30-35 days
Study Arms (2)
Acute myocardial infarctions group
EXPERIMENTAL200 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.
Control group
ACTIVE COMPARATOR200 MBq 68Ga-NODAGA-E\[c(RGDyK)\]2 administered IV. one time.
Interventions
200 MBq 68Ga-NODAGA-E\[c(RGDyK)\]2 administered IV.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Physiology, Nuclear Medicine and PET
Copenhagen, Capital Region, 2100, Denmark
Study Officials
- STUDY DIRECTOR
Andreas Kjær, MD
Rigshospitalet, Denmark
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
February 18, 2018
First Posted
February 26, 2018
Study Start
February 20, 2018
Primary Completion
July 1, 2020
Study Completion
July 1, 2020
Last Updated
July 14, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share