Ultrasound-guided ulnar nerve PCR test to diagnose and monitor leprosy
Accuracy of the Polymerase Chain Reaction of Ulnar Perineural Subcutaneous Aspirate Guided by Ultrasound for the Diagnosis and Monitoring of Leprosy Cure
This test uses an ultrasound-guided needle sample from the ulnar nerve combined with PCR to see if it can detect Mycobacterium leprae and help diagnose or monitor people with suspected or confirmed leprosy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | University of Brasilia Academic / other |
| Locations | 1 site (Brasília, Federal District) |
| Trial ID | NCT07515989 on ClinicalTrials.gov |
What this trial studies
This prospective cohort uses ultrasound to guide a perineural subcutaneous aspirate of the ulnar nerve and applies PCR (including RLEP and 16S targets) to detect M. leprae DNA and RNA. Researchers will combine clinical exam, nerve ultrasound findings, and molecular results to measure diagnostic accuracy and potential markers of bacterial viability for treatment monitoring. Participants are people aged 14 and older with clinical suspicion of leprosy or peripheral nerve enlargement and no prior leprosy treatment. The approach aims to improve detection in neural forms of leprosy where skin tests and biopsies have limited sensitivity.
Who should consider this trial
Good fit: Ideal candidates are people aged 14 or older with clinical signs or suspicion of leprosy or peripheral nerve enlargement who have not received prior leprosy treatment and can provide informed consent.
Not a fit: Patients previously treated for leprosy, those with contraindications to aspiration (for example coagulopathy or local infection), or people without nerve involvement are unlikely to benefit from this procedure.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive, more sensitive way to diagnose nerve-involved leprosy and help monitor whether bacteria remain viable during and after treatment.
How similar studies have performed: Prior work has shown that RLEP PCR and high-resolution nerve ultrasound separately improve leprosy detection, but combining ultrasound-guided perineural aspirate PCR and RNA-based viability markers is relatively novel and less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Individuals aged 14 years or older; Clinical suspicion of leprosy based on dermatologic or neurologic examination OR; Presence of peripheral nerve enlargement or skin lesions compatible with leprosy; Ability to provide written informed consent. \- Exclusion Criteria: Previous treatment for leprosy; Contraindication to the aspiration procedure (e.g., coagulopathy or anticoagulant therapy); Local infection at the puncture site; Inability or unwillingness to provide informed consent.
Where this trial is running
Brasília, Federal District
- University Hospital of Brasília — Brasília, Federal District, Brazil (Recruiting)
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.