PET Imaging of MMP Activation in AAA: Clinical Component
ConditionAbdominal Aortic Aneurysm
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
A first-in-human evaluation of \[64Cu\]-RYM2 with PET/CT will be performed to: a) assess its safety, biodistribution, and radiation dosimetry in normal volunteers (WU) and; b) in AAA patients undergoing surgery (WU and Yale), evaluate radiotracer pharmacodynamics and correlate PET imaging characteristics (WU) with ex vivo tissue measurements (Yale).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
No history of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol-specified imaging sessions.
Able to comprehend and willing to follow instructions for the study procedures as called for by the protocol.
Capable of lying still and supine within the PET/CT scanner for ~1 hour and follow instructions for breathing protocol during the CT portion.
No illicit drug use or other inhaled drug use (including pharmacologic agents, recreational agents, or illicit drugs) within the past year.
Disqualifiers
Inability to receive and sign informed consent;
Pregnant (confirmed by urine pregnancy test) and/or breastfeeding
Patient with chronic renal disease whose glomerular filtration rate (GFR) is less than 30 mL/min/1.73 m2
Patients with an unstable clinical condition that in the opinion of the principal investigators or designee precludes participation in the study.
Trial design
Design model
Single group
Treatments tested in this trial
Cu-64-RYM2
DrugPET/CT scan
PET imaging using Cu-64
DrugPET/CT at different timepoints
Treatment groups
28 Participants
are divided into 1 treatment groupGroup A: dosimetry and AAA patientsOther 2 interventions
Trial outcomes
Primary outcomes
1
Verification Cu-64RYM2-2 signal in AAA segments. This will be performed by measuring Standard Uptake Values obtained from analysis of the Cu-64RYM2 images, in AAA patients.
Verification Cu-64RYM-2 signal is present in AAA segment of the abdominal aorta
Time frame
2 yearsSecondary outcomes
1
Cu-64RYM-2 signal is higher
MMP activity will be higher in AAA patients than in healthy volunteers
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov