PET Imaging of MMP Activation in AAA: Clinical Component

Purpose

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).

Condition

  • Abdominal Aortic Aneurysm

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

Healthy Volunteers - 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. - No known history of cardiac, pulmonary, hepatic or renal disease or diabetes - BMI ≤ 40

Exclusion Criteria

Healthy Volunteers - 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. - Is deemed likely to be unable to perform all research procedures for any reason, (e.g., subjects unable to lie still or inability to tolerate up to 60 minutes in a supine position with arms up during the PET imaging procedures due to chronic back/shoulder pain or arthritis as assessed by physical examination and medical history). - Currently using recreational drugs. - Body weight of >300 lbs. (weight limit of the PET table). - Currently enrolled in another study using an investigational drug or underwent a study the last year involving investigational use of radiotracers or CT would confound results or with a radiation exposure when combined with this study would be deemed as excessive by the Sponsor-Investigator. Inclusion Criteria: Patients with AAA electively or semi-electively scheduled for surgical repair - Men or women 40-80 years of age - Willing and able to provide informed consent - Medically managed hypertension and hyperlipidemia - 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 - Patients with AAA indicated for surgical repair (5.0 [female] - 5.5cm [male]), incidentally identified large(r) AAAs (>5.5 or 6.0 cm), and rapidly expanding AAAs (> 0.5 cm in 6 months or > 1 cm in 12 months) per Guidelines of the Society for Vascular Surgery. Exclusion Criteria: Patients with AAA electively or semi-electively scheduled for surgical repair - Inability to receive and sign informed consent. - Currently enrolled in another study using an investigational drug - Pregnant (confirmed by urine pregnancy test) and/or breastfeeding - Patient with chronic renal disease whose GFR is less than 30 mL/min/1.73 m2 - Documented allergy to iodinated contrast and/or shellfish - Patients with an unstable clinical condition that in the opinion of the principal investigators or designee precludes participation in the study. - Inability to tolerate 60 minutes in a supine position with arms down at sides, as necessary for PET/CT. - Other conditions such as symptomatic/recently treated coronary disease, cancer requiring oncologic management, or autoimmune/inflammatory diseases (e.g., rheumatoid arthritis or multiple sclerosis). - Non-AAA volunteers may not carry a diagnosis of aortoiliac occlusive disease, as documented by their treating vascular surgeon, as significantly progressed atherosclerotic disease may demonstrate exaggerated, associated MMP activity.

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
dosimetry and AAA patients
Patients who have abdominal aortic aneurysm and healthy volunteers
  • Drug: Cu-64-RYM2
    PET/CT scan
  • Drug: PET imaging using Cu-64
    PET/CT at different timepoints

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University School of Medicine
St Louis, Missouri 63110
Contact:
Kitty Harrison, RN, BSN
314-747-0183
kittydharrison@wustl.edu

More Details

NCT ID
NCT07473102
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Kitty Harrison, RN, BSN
314-747-0183
kittydharrison@wustl.edu

Detailed Description

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).