28 Participants NeededMy employer runs this trial

PET Imaging for Abdominal Aortic Aneurysm

(PET AAA Trial)

RG
Overseen ByRobert Gropler, MD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Washington University School of Medicine
Must be taking: Antihypertensives, Statins
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

RG

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

* 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.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Dosimetry Assessment

Participants undergo PET/CT imaging to assess safety, biodistribution, and radiation dosimetry of [64Cu]-RYM2

1-2 weeks
1 visit (in-person)

Surgical Evaluation

AAA patients undergo surgery and radiotracer pharmacodynamics are evaluated, correlating PET imaging with ex vivo tissue measurements

1-2 weeks
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging and surgical procedures

4 weeks

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

Group I: dosimetry and AAA patientsExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

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.

Positron 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- ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/25883125/

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) ...

Positron 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 ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36649454/

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.