Clinical trial • Phase II • Cardiology | Other

[68GA]NODAGA-GLU(CYCLO[-ARG-GLY-ASP-D-TYR-LYS)]2 for Chronic ischemic heart disease

Phase II trial of [68GA]NODAGA-GLU(CYCLO[-ARG-GLY-ASP-D-TYR-LYS)]2 for Chronic ischemic heart disease. None/Not specified-controlled. 42 participants.

Overview

Trial Therapeutic Area
Cardiology | Other
Trial Disease
Chronic ischemic heart disease
Trial Stage
Phase II
Drug Modality
Radiopharmaceutical

Key dates

Initial CTIS Submission Date
29-11-2024
First CTIS Authorization Date
08-01-2025

Trial design

None/Not specified-controlled Phase II trial across 1 site in Denmark.

Comparator
None/Not specified
Target Sample Size
42

Eligibility

Recruits 42 No vulnerable population selected (isVulnerablePopulationSelected:false). Informed consent documents are present (see subject information and informed consent forms listed in documents); participants are adults (>50 years). No assent/minor procedures specified..

Pregnancy Exclusion
If the subject is of childbearing age, a pregnancy test will be performed prior to the injection of the tracer. If positive, the patient will be excluded from the study
Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected:false). Informed consent documents are present (see subject information and informed consent forms listed in documents); participants are adults (>50 years). No assent/minor procedures specified.

Inclusion criteria

  • {"criterion_text":"- Subjects > 50 years old\n- Subjects admitted to the Heart Center, Rigshospitalet, with chronic occlusion of coronary arteries and clinically referred for either PCI or CABG."}

Exclusion criteria

  • {"criterion_text":"- Subject with a history of heart surgery\n- If the subject shows clinical signs of a severe allergic reaction related to intravenous contrast agent or the tracer, the patient will be withdrawn from the study\n- If it is discovered during the PET scan that the tracer has been injected subcutaneously, the subject will be withdrawn from the project\n- Uncontrolled diabetes type I & II (HbA1c >70)\n- Subject receiving strong anti-angiogenic medication such as Avastin ©\n- Pregnancy\n- Lactation\n- Severe claustrophobia to a degree that makes PET/CT scanning impossible\n- Severe obesity (>140 kg)\n- Re-operation during intervention\n- Conversion from PCI to open surgery\n- If the subject is of childbearing age, a pregnancy test will be performed prior to the injection of the tracer. If positive, the patient will be excluded from the study"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Characterize the difference in myocardial angiogenesis measured with RGD-PET uptake before and after coronary revascularization","definition_or_measurement_approach":"Measured as myocardial angiogenesis using RGD-PET uptake before and after coronary revascularization (comparison of uptake pre- and post-revascularization)."}

Secondary endpoints

  • {"endpoint_text":"- Correlation between myocardial angiogenic response (determined by RGD-PET) and changes in myocardial perfusion (82Rb-PET) after coronary revascularization.","definition_or_measurement_approach":"Correlation analysis between RGD-PET–determined angiogenic response and myocardial perfusion changes assessed by 82Rb-PET after revascularization."}
  • {"endpoint_text":"- Correlation between myocardial angiogenic response after 3 weeks (determined by RGD-PET) and functional recovery and final infarct (18F-FDG-PET) size 6-8 weeks after coronary revascularization","definition_or_measurement_approach":"Correlation between RGD-PET angiogenic response at 3 weeks and functional recovery/final infarct size assessed by 18F-FDG-PET at 6-8 weeks post-revascularization."}
  • {"endpoint_text":"- Correlation between myocardial angiogenic response (determined by RGD-PET) and viability (18-F-FDG) before and after coronary revascularization","definition_or_measurement_approach":"Correlation between RGD-PET angiogenic response and myocardial viability assessed by 18F-FDG PET before and after revascularization."}

Recruitment

Planned Sample Size
42
Recruitment Window Months
19
Consent Approach
Informed consent obtained using subject information and informed consent forms (documents listed: 'Deltagerinformation_iskmi_CABG_vers_7_24_10_2024', 'Deltagerinformation_iskmi_PCI_vers_7_24_10_2024', and earlier versions). Consent provided by adult participants (>50 years). No assent or minor-specific consent documents specified. Languages not specified.

Methods

  • Recruitment from patients admitted to the Heart Center, Rigshospitalet (patients with chronic occlusion of coronary arteries clinically referred for PCI or CABG).

Geography

Total Number Of Sites
1
Total Number Of Participants
42

Denmark

Earliest CTIS Part Ii Submission Date
07-01-2025
Latest Decision Or Authorization Date
08-01-2025
Processing Time Days
1
Number Of Sites
1
Number Of Participants
42

Sites

Site Name
Rigshospitalet
Department Name
Clinical Physiology and Nuclear Medicine
Contact Person Name
Johanne Madsen
Number Of Participants
42

Sponsor

Primary sponsor

Full Name
Rigshospitalet
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
[68Ga]NODAGA-E[c(RGDyK)]2
Active Substance
[68GA]NODAGA-GLU(CYCLO[-ARG-GLY-ASP-D-TYR-LYS)]2
Modality
Radiopharmaceutical
Routes Of Administration
INJECTION
Route
INJECTION
Authorisation Status
1
Maximum Dose
300 MBq (max daily); 600 MBq (max total)

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