Detecting leg and foot stress fractures using advanced CT technology
Assessing Patients With Suspected Stress or Insufficiency Fracture of the Lower Extremity With Photon-Counting-Computed-Tomography
This study is testing a new type of CT scan to see if it can better find stress fractures in the legs and feet for patients who might have them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Balgrist University Hospital Academic / other |
| Locations | 1 site (Zürich, Zurich) |
| Trial ID | NCT06024798 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the diagnostic accuracy of Photon-Counting Computed Tomography (PCCT) in detecting stress fractures in the lower extremities, which are often missed by traditional imaging methods. Stress fractures occur due to chronic stress on bones and can lead to significant complications if not diagnosed early. The study will include patients with clinically suspected stress fractures who will undergo PCCT and MRI for confirmation. The focus is on optimizing patient care while adhering to radiation safety principles.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16 and older with clinically suspected stress or insufficiency fractures of the lower extremity.
Not a fit: Patients under 16 years of age, pregnant individuals, those with metal implants, or those with infections or tumors affecting the lower extremity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early diagnosis of stress fractures, enhancing patient outcomes and treatment efficacy.
How similar studies have performed: While traditional imaging methods have limitations, the use of advanced CT technology like PCCT is a novel approach that has not been extensively tested in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 16 years of age. Minor study subjects can have an additional signature by the parent or legal guardian * Clinically suspected stress or insufficiency fracture of the lower extremity * Written consent of study participation * Patients who will have an MRI to confirm the diagnosis of a suspected stress fracture Exclusion Criteria: * \< 16 years of age * Pregnancy * Metal implants * Postoperative situation * Infection or tumorous disease affecting the lower extremity
Where this trial is running
Zürich, Zurich
- Balgrist University Hospital — Zürich, Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Stephan Wirth, PD Dr.med. — Balgrist University Hospital
- Study coordinator: Viehöfer Arnd, PD Dr.med.
- Email: Arnd.Viehöfer@balgrist.ch
- Phone: +41 44 386 57 55
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.