Phase II: 68Ga-NODAGA-E[c(RGDyK)]2 Angiogenese PET for imaging angiogenesis in ST-Elevation Myocardial Infarction(STEMI)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002709-36-DK

Enrollment

Registered

2017-07-07

Start date

2017-11-21

Completion date

Unknown

Last updated

2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ST-Elevation Myocardial Infarction (STEMI) MedDRA version: 20.0 Level: LLT Classification code 10019250 Term: Heart attack System Organ Class: 100000011654 MedDRA version: 20.0 Level: LLT Classification code 10064346 Term: STEMI System Organ Class: 100000011652

Interventions

Product Name: 68Ga-NODAGA-E[c(RGDyK)]2 Product Code: 68Ga-NODAGA-E[c(RGDyK)]2 Pharmaceutical Form: Concentrate and solvent for solution for injection INN or Proposed INN: 68Ga-NODAGA-E[RGDyK)]2 Curr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The inclusion criteria are patients diagnosed with ST-Elevation Myocardial Infarction (STEMI), treated with Percutaneous Coronary Intervention (PCI). The patients must be above the age of 18 years, and must be capable of understanding and giving full informed written consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: The principal exclusion criteria are: 1. Patient with prior STEMI 2. Patient who prior underwent cardiac surgery 3. Patient recieving anti-angiogenetick treatmen 4. Patient with known allergi towards interveneous contrast 5. Patient with pacemaker, cochlear implant or insulinpump 6. Pregnancy 7. Lactation 8. Obesity (weight above 140 kg) 9. Claustrophobia

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to test a new radio tracer called 68Ga-NODAGA-E-[RGDyK]2 for PET imaging of angiogenesis. The tracer has the potential of identifying heart tissue with a high level of angiogenesis. Angiogenesis is a very important factor in reparing heart tissue after an heartattack. therefor, the tracer can potentially be used to asses how the tissue respons to the chosen therapy. ;Secondary Objective: non applicable;Primary end point(s): To evaluate myocardial angiogenesis using 68Ga-NODAGA-E-[RGDyK]2 after PCI ;Timepoint(s) of evaluation of this end point: The patient will be PET scanned after injection af the radio tracer 68Ga-NODAGA-E-[RGDyK]2. The patient will be scanned on three different days: 1. Scan: 1-3 days after PCI 2. Scan: 7-10 days after PCI 3. Scab: 30-35 days after PCI	—

Measure

Time frame

Main Objective: The primary objective of the study is to test a new radio tracer called 68Ga-NODAGA-E-[RGDyK]2 for PET imaging of angiogenesis. The tracer has the potential of identifying heart tissue with a high level of angiogenesis. Angiogenesis is a very important factor in reparing heart tissue after an heartattack. therefor, the tracer can potentially be used to asses how the tissue respons to the chosen therapy. ;Secondary Objective: non applicable;Primary end point(s): To evaluate myocardial angiogenesis using 68Ga-NODAGA-E-[RGDyK]2 after PCI ;Timepoint(s) of evaluation of this end point: The patient will be PET scanned after injection af the radio tracer 68Ga-NODAGA-E-[RGDyK]2. The patient will be scanned on three different days: 1. Scan: 1-3 days after PCI 2. Scan: 7-10 days after PCI 3. Scab: 30-35 days after PCI

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Secondary

Measure	Time frame
Secondary end point(s): - Quantitative uptake of 68Ga-NODAGA-E-[RGDyK]2 and change in myocardial perfusion after PCI - Quantitative uptake of 68Ga-NODAGA-E-[RGDyK]2 and functional recovery 30 days after PCI - Quantitative uptake of 68Ga-NODAGA-E-[RGDyK]2 and viability after PCI;Timepoint(s) of evaluation of this end point: Quantitative uptake of 68Ga-NODAGA-E-[RGDyK]2 in the heart will be assessed by PET scans after injection.	—

Measure

Time frame

Secondary end point(s): - Quantitative uptake of 68Ga-NODAGA-E-[RGDyK]2 and change in myocardial perfusion after PCI - Quantitative uptake of 68Ga-NODAGA-E-[RGDyK]2 and functional recovery 30 days after PCI - Quantitative uptake of 68Ga-NODAGA-E-[RGDyK]2 and viability after PCI;Timepoint(s) of evaluation of this end point: Quantitative uptake of 68Ga-NODAGA-E-[RGDyK]2 in the heart will be assessed by PET scans after injection.

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Countries

Denmark

Contacts

Public ContactSimon Bentsen

Rigshospitalet, Department og Clinical Physiology, Nuclear Medicine and PET

simon.bentsen.01@regionh.dk004535451793

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026