PET Imaging for Abdominal Aortic Aneurysm
(PET AAA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new imaging method, Cu-64-RYM2 (a radioactive imaging agent), with PET/CT to assess its safety and effectiveness in detailing abdominal aortic aneurysms (AAA) before surgery. The researchers aim to understand how the body processes this imaging agent and how it compares to actual tissue samples. Healthy volunteers without major health issues and individuals with AAA needing surgery may be suitable for this study. Participants must be comfortable lying still in a scanner for about an hour. As an Early Phase 1 trial, this research focuses on understanding how this new imaging method works in people, offering participants a chance to contribute to groundbreaking medical advancements.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that patients with AAA should have medically managed hypertension and hyperlipidemia, suggesting that continuing these medications might be necessary.
What prior data suggests that this PET imaging method is safe?
In previous studies, the treatment under testing, called Cu-64-RYM2, did not cause harmful effects in mice, indicating safety for the animals. When combined with a special form of copper, Cu-64, used in imaging tests, the treatment remained stable in both mouse and human blood. Stability is crucial because it ensures the treatment functions properly without breaking down in the body.
This trial is in its early stages, specifically "Early Phase 1," which primarily focuses on identifying any safety issues when the treatment is first used in humans. While animal study results are promising, this trial will determine if the treatment is safe and well-tolerated in people.12345Why are researchers excited about this trial?
Unlike traditional treatments for abdominal aortic aneurysms, which typically involve surgical intervention, Cu-64-RYM2 offers a novel approach by utilizing PET imaging. This method uses a radioactive tracer that targets specific proteins in the aneurysm, allowing for detailed imaging and potentially earlier detection of changes in the aneurysm's size or activity. Researchers are excited about this treatment because it could provide a non-invasive way to monitor aneurysms, leading to more timely and personalized treatment plans.
What evidence suggests that this PET imaging technique is effective for abdominal aortic aneurysm?
Research has shown that Cu-64-RYM2 holds promise for imaging abdominal aortic aneurysms (AAA). Studies indicate it effectively attaches to both normal and swollen aortic tissues, which are linked to tissue breakdown in aneurysms. This tracer provides clear PET images, aiding doctors in visualizing these areas. The trial will evaluate Cu-64-RYM2 in patients with AAA and healthy volunteers to monitor and assess the condition more effectively. Early data suggest that Cu-64-RYM2 offers good imaging contrast, simplifying the identification of problem areas in the aorta.24678
Who Is on the Research Team?
Robert Gropler, MD
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for adults with an abdominal aortic aneurysm scheduled for surgery, as well as healthy volunteers. Participants must be able to lie still in a scanner for about an hour, follow instructions, not have major health issues or claustrophobia, and not use illicit drugs.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Imaging and Dosimetry Assessment
Participants undergo PET/CT imaging to assess safety, biodistribution, and radiation dosimetry of [64Cu]-RYM2
Surgical Evaluation
AAA patients undergo surgery and radiotracer pharmacodynamics are evaluated, correlating PET imaging with ex vivo tissue measurements
Follow-up
Participants are monitored for safety and effectiveness after imaging and surgical procedures
What Are the Treatments Tested in This Trial?
Interventions
- Cu-64-RYM2
Trial Overview
The study tests the safety and body distribution of a new imaging agent called Cu-64-RYM2 using PET/CT scans. It aims to see how well this tracer works in both healthy people and patients with abdominal aortic aneurysms.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients who have abdominal aortic aneurysm and healthy volunteers
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Citations
PET Imaging for Abdominal Aortic Aneurysm (PET AAA Trial)
... Cu-64-RYM2 will have tolerable side effects & efficacy for patients with Abdominal Aortic Aneurysm and Abdominal Aortic Aneurysm. See if you qualify today!
PET Imaging of Abdominal Aortic Aneurysm with 64 Cu ... - PMC
Our goal is to investigate a novel probe for effective targeting and imaging of AAA with excellent targeting specificity and imaging contrast. ... PET data.
3.
ahajournals.org
ahajournals.org/doi/abs/10.1161/CIRCIMAGING.122.014615?doi=10.1161/CIRCIMAGING.122.014615Positron Emission Tomography Imaging of Vessel Wall ...
Cu-RYM2 specifically bound to normal and aneurysmal human aortic tissues in correlation with MMP activity. Conclusions: 64Cu-RYM2 is a first-in- ...
PET Imaging of Abdominal Aortic Aneurysm with ... - PubMed
(64)Cu-NOTA-TRC105-Fab cleared rapidly through the kidneys, which enabled noninvasive PET imaging of the aorta with enhanced contrast and showed increased ...
Positron Emission Tomography Imaging of Vessel Wall ...
If validated in humans, 64Cu-RYM2 positron emission tomography may help improve the outcome of patients with AAA. Abdominal aortic aneurysm (AAA) ...
6.
ahajournals.org
ahajournals.org/doi/10.1161/CIRCIMAGING.122.014615?doi=10.1161/CIRCIMAGING.122.014615Positron Emission Tomography Imaging of Vessel Wall ...
Toxicology studies showed no adverse reaction in mice. Upon radiolabeling with Cu-64, the resulting tracer was stable in murine and human blood ...
Positron Emission Tomography Imaging of Vessel Wall ...
Our data demonstrate favor- able characteristics of 64Cu-RYM2, which enabled in vivo imaging and quantification of MMP activity, and indirectly inflammation, in ...
Positron Emission Tomography Imaging of Vessel Wall Matrix ...
These data set the stage for 64Cu-RYM2-based translational imaging studies of vessel wall MMP activity, and indirectly, inflammation, in AAA.
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