Feasibility of PheCheck for detecting phenylalanine levels
PheCheck Feasibility Study
This study is testing a new device called PheCheck to see if it can accurately measure phenylalanine levels in people with Phenylketonuria (PKU) compared to the standard lab method.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 10 Years and up |
| Sex | All |
| Sponsor | Lumos Diagnostics Industry-sponsored |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05998109 on ClinicalTrials.gov |
What this trial studies
This feasibility study aims to compare the accuracy of PheCheck™, a device for rapid quantitative detection of phenylalanine (Phe), against the gold standard HPLC amino acid analyzer in patients with Phenylketonuria (PKU). The study will enroll participants aged 10 years and older who are being monitored for PKU or related conditions. It will assess both the accuracy of PheCheck and its ease of use by lay participants, utilizing capillary blood samples for analysis.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 10 years and older who are being monitored for Phenylketonuria or hyperphenylalaninemia.
Not a fit: Patients younger than 10 years or those not being monitored for PKU or related conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and rapid method for monitoring phenylalanine levels in patients with PKU.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, making this a potentially novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 10 years of age or older * Being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during pregnancy Signed informed consent Exclusion Criteria: * Younger than 10 years of age * Not being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during pregnancy * Lack of signed informed consent * Previous enrollment in the study and has completed study visit 1 and 2
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Catalina Suarez-Cuervo, MD
- Email: Catalina.Suarez@lumosdiagnostics.com
- Phone: 7277765880
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.