Pimonidazole Hydrochloride for Thoracic Aortic Aneurysm

No longer recruiting at 1 trial location

Overseen By Manal Al-Suqi, MSTC

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Thomas Gleason

Disqualifiers: Severe infection, Pregnancy, Recent surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: < 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Pimonidazole Hydrochloride to determine if it can safely detect low oxygen levels in the tissues of individuals with an ascending aortic aneurysm. An aortic aneurysm occurs when the aorta, the large artery from the heart, balloons out, posing a danger. The trial includes two groups: one with aortic aneurysms and another with related heart issues, such as heart valve problems. It suits adults needing surgery for an aortic aneurysm, heart valve replacement, or coronary artery bypass. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that pimonidazole hydrochloride is likely to be safe for humans?

Research has shown that pimonidazole hydrochloride detects low oxygen levels in tissues, a condition known as hypoxia. This substance is primarily recognized for identifying hypoxic areas in tumors. The current study is in its early phase, aiming to assess the treatment's safety and how the body processes it. Although limited safety data exists for pimonidazole hydrochloride in humans, early-phase studies typically monitor for any side effects or adverse reactions.

The treatment is administered in a single dose before surgery, reducing the risk of long-term side effects. Since pimonidazole hydrochloride is already used as a hypoxia marker in other contexts, it may be well-tolerated. However, detailed safety results from this specific study are still needed to provide more definitive evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Pimonidazole Hydrochloride is unique because it offers a new approach to managing thoracic aortic aneurysms by possibly identifying low-oxygen areas in tissues. Unlike current treatments that mainly focus on surgical intervention or blood pressure management, pimonidazole works as a hypoxia marker, potentially allowing doctors to better assess which areas of the aorta are at risk due to low oxygen levels. Researchers are excited about this treatment because it could lead to more targeted and effective surgical planning, ultimately improving patient outcomes.

What evidence suggests that pimonidazole hydrochloride is effective for detecting tissue hypoxia in thoracic aortic aneurysm?

Research has shown that pimonidazole hydrochloride helps identify areas with low oxygen levels in tissues. Early results suggest it can detect these low-oxygen spots in the thoracic aorta, which is important for understanding conditions like thoracic aortic aneurysm. In this trial, participants in the "Aneurysmal" arm, who are candidates for aortic replacement due to aneurysm, will receive pimonidazole hydrochloride to assess its effectiveness in detecting these areas. Participants in the "Non-aneurysmal" arm, undergoing coronary artery bypass graft or aortic valve replacement, will also receive the treatment for comparison. Identifying these low-oxygen areas is crucial because they can cause tissue damage. Detecting them may help doctors manage and treat aneurysms more effectively. Although more research is needed, pimonidazole hydrochloride appears promising in improving how doctors assess and treat aneurysms. ^{1 6 7 8 9}

Who Is on the Research Team?

Thomas G Gleason, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for patients needing thoracic aorta repair due to aneurysm, aortic valve replacement, or coronary artery bypass. They must have certain blood cell counts and organ functions within normal ranges and be able to consent. Those of childbearing potential must agree to use contraception.

Inclusion Criteria

White blood cells > 2500/µ;

Platelets > 100,000/µL;

Hemoglobin > 8 g/dl.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are administered pimonidazole-HCl orally in a single dose 24 hours prior to scheduled surgical time

< 1 week

1 visit (in-person)

Surgery and Sample Collection

During surgery, aortic specimens are harvested for hypoxia assessment

< 1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pimonidazole Hydrochloride

Trial Overview The study tests Hypoxyprobe-1 (pimonidazole hydrochloride) for detecting tissue hypoxia in patients with ascending aortic aneurysm. It's prospective, ensuring participants meet criteria through imaging reviews before inclusion.

How Is the Trial Designed?

Group I: Aneurysmal Experimental Treatment 1 Intervention

Intervention: four patients who are candidates for aortic replacement due to aneurysm will be administered pimonidazole-HCl orally in a single dose (0.5g/m2) 24 hours prior to scheduled surgical time.

Group II: Non aneurysmal Active Control 1 Intervention

Intervention: four non-aneurysmal patients undergoing coronary artery bypass graft or aortic valve replacement will be administered pimonidazole-HCl orally in a single dose (0.5g/m2) 24 hours prior to scheduled surgical time.

Who Is Running the Clinical Trial?

Thomas Gleason

Lead Sponsor

Trials

1

Recruited

40+

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11293951/

results from the Effective Treatments for Thoracic Aortic ... The aim of this study was to explore whether basing clinical management on aneurysm size index (maximum aneurysm diameter/body surface area) ...

2. go.drugbank.com go.drugbank.com/conditions/DBCOND0054906

Thoracic Aortic Aneurysm (TAA) (DBCOND0054906) Effective Treatments for Thoracic Aortic Aneurysms (ETTAA Study): A ... Detection of Hypoxia in Human Thoracic Aorta Using Pimonidazole Hydrochloride.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9246658/

the effective treatments for thoracic aortic aneurysms study Outcomes were aneurysm growth, survival, quality of life (using the EQ-5D-5L utility index), and hospital admissions. Between 2014 and 2018, 886 ...

4. ahajournals.org ahajournals.org/doi/full/10.1161/JAHA.118.009205?doi=10.1161/JAHA.118.009205

Aryl Hydrocarbon Receptor Nuclear Translocator in ... These results indicate that mice with tissue‐specific deletion of Arnt in the smooth muscle appear healthy overall, without compromise of ...

5. nature.com nature.com/articles/ncomms13016

ANGPTL2 activity in cardiac pathologies accelerates heart ... Together, these results suggest that increased ANGPTL2 activity accelerates cardiac dysfunction and that therapeutic ANGPTL2 suppression could ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03410420/detection-of-hypoxia-in-human-thoracic-aorta-using-pimonidazole-hydrochloride

Detection of Hypoxia in Human Thoracic Aorta Using ... This is a prospective study designed to determine the safety and value of Hypoxyprobe-1 (pimonidazole hydrochloride (-HCl)) to detect levels ...

7. medchemexpress.com medchemexpress.com/pimonidazole-hydrochloride.html?srsltid=AfmBOooZge56FbhO1arveY6RiCgf58xe0Qt5Dwbbkm2k2noRVo-E-ELG

Pimonidazole hydrochloride | Hypoxia Marker Pimonidazole is a novel hypoxia marker for complementary study of tumor hypoxia and cell proliferation in tumor.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17888967/

Safety of thoracic aortic surgery in the present era Conclusions: Aortic surgery is quite safe in the current era and leads to good long-term survival for this patient group. These data support prophylactic ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03536312

Treatment in Thoracic Aortic Aneurysm: Surgery vs ... When the ascending aorta tears or ruptures, the risk dying is high even if surgery is done as soon as possible. Traditionally, when the ascending aorta gets ...