Using advanced imaging to better understand solitary bone lesions
Contribution of MUltiparametric Analysis in Bone Scintigraphy for the Characterisation of Solitary Bone Lesions Whose Malignant Origin Cannot be Excluded on Conventional Imaging
This study is testing a new imaging technique to see if it can help doctors better understand solitary bone lesions and tell apart harmless ones from cancerous ones, which could reduce the need for unnecessary biopsies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Central Hospital, Nancy, France Academic / other |
| Locations | 1 site (Vandœuvre-lès-Nancy) |
| Trial ID | NCT05934994 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of multiparametric analysis using Single Photon Emission Computed Tomography (SPECT-CT) in characterizing solitary bone lesions. The approach involves a three-stage bone scintigraphy process that assesses perfusion, early tissue uptake, and late bone fixation. The goal is to improve the accuracy of diagnosing these lesions, particularly in distinguishing between benign and malignant cases, thereby reducing the need for unnecessary biopsies. By quantifying the intensity of the signal at different stages, the study aims to provide clearer insights into the nature of the lesions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with indeterminate solitary bone lesions who are facing potential biopsy or excision.
Not a fit: Patients who are pregnant, have unstable medical conditions, or have known allergies to the radiopharmaceutical used will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the number of unnecessary biopsies and associated complications for patients with solitary bone lesions.
How similar studies have performed: While the use of SPECT-CT in bone imaging is established, this specific multiparametric analysis approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Person, having received complete information on the organization of the research and having signed the informed consent and: * Age ≥ 18 years old. * Having read and understood the information document. * Affiliated to a social security scheme. * Patient with an indeterminate solitary bone lesion on conventional imaging, for which an indication for biopsy +/- excision is planned. Exclusion Criteria: * Pregnant woman or woman of childbearing age and without contraceptive means or nursing mother. * Unstable medical condition and/or inability to remain still during recordings. * Known allergy to one of the components of the radiopharmaceutical technetium-99m-Technescan HDP (product required to perform the bone scan). * Person referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code. * Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under articles L. 3212-1, L. 3213-1
Where this trial is running
Vandœuvre-lès-Nancy
- CHRU Nancy — Vandœuvre-lès-Nancy, France (Recruiting)
Study contacts
- Study coordinator: ACHRAF BAHLOUL, MD, MSc
- Email: a.bahloul@chru-nancy.fr
- Phone: 383154003
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.