Bone LesionMUSICNCT05934994
Contribution of MUltiparametric Analysis in Bone Scintigraphy for the Characterisation of Solitary Bone Lesions
A study testing Bone scan in people with Bone Lesion, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The hypothesis of the study is that non-invasive Single photon emission computed tomography (SPECT-CT) bone scintigraphy makes it possible to better characterize solitary bone lesions, in particular the exclusion of their malignancy in order to avoid unnecessary biopsy and possible complications for the patient. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bone Lesion
- What is being tested?
- Bone scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 11 Sep 2023to 10 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU Nancy
Vandœuvre-lès-Nancy, 54511
VERONIQUE ROCH, MSc, 0383154276 ext. +33, v.roch@chru-nancy.fr
About this study
Official title: Contribution of MUltiparametric Analysis in Bone Scintigraphy for the Characterisation of Solitary Bone Lesions Whose Malignant Origin Cannot be Excluded on Conventional Imaging
The hypothesis of the study is that non-invasive Single photon emission computed tomography (SPECT-CT) bone scintigraphy makes it possible to better characterize solitary bone lesions, in particular the exclusion of their malignancy in order to avoid unnecessary biopsy and possible complications for the patient.
Read the detailed description
Bone scintigraphy includes 3 stages: study of perfusion then of early tissue uptake and finally of late bone fixation.
Hyperactivity of malignant bone lesions at the 3 stages of bone scintigraphy has been reported, but on planar scintigraphic images not allowing precise anatomical localization of the lesions.
Currently, the generalization of SPECT-CT (Single Photon Emission Computed Tomography) combined with Tomodensitometry) acquisition thanks to the deployment of semiconductor cameras, makes it possible to carry out a multiparametric analysis of bone lesions with quantification of the intensity of the signal expressed in SUVmax (Standard Uptake Value maximum) at the 3 times of the scintigraphy
- Conditions
- Bone Lesion
- Being tested
- Bone scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone scanOther
Also called Bone scan in single photon emission computed tomography
the bone scintigraphy will include 3 stages: study of perfusion then early tissue uptake and finally late bone fixation
| Study group | Role | What they receive |
|---|---|---|
| Patients with undetermined solitary bone lesions | Experimental | All patients with indeterminate solitary bone lesions undetermined on conventional imaging for whom a biopsy or excision is scheduled, will be able to participate in the study. Receives: Other: Bone scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the diagnostic performance of the Time To Peak parameter
Sensitivity, specificity, positive predictive value and negative predictive value of the dynamic parameter Time-to-peak to characterize a benign lesion. The Time-To-Peak is defined by the time to reach the SUVmax peak, i.e. the top of the perfusion curve. The benign character is defined by criteria of biopathology at the biopsy +/- surgery.
Measured: 24 hours
Secondary outcomes (3)
To evaluate the diagnostic performance of the Standard Uptake Value max at the early stage (2nd stage) in bone scintigraphy in the evaluation of the benign nature of indeterminate solitary bone lesions on conventional imaging.
Sensitivity, specificity, Positive Predictive Value and Negative Predictive Value of the Standard Uptake Value max at the early time to characterize a benign lesion.
Measured: 24 hours
o evaluate the diagnostic performance of the Standard Uptake Value max at the early stage (3 rd stage) in bone scintigraphy in the evaluation of the benign nature of indeterminate solitary bone lesions on conventional imaging.
Sensitivity, specificity, Positive Predictive Value and Negative Predictive Value of the Standard Uptake Value max at the late stage to characterize a benign lesion.
Measured: 24 hours
Evaluate the impact of multiparametric analysis (combination of Time-To-Peak, Standard Uptake Value max early and late) in the classification of solitary bone lesions in bone scintigraphy.
Number of patients with a benign lesion on multiparametric bone scintigraphy analysis among patients with an indeterminate bone lesion on conventional imaging and having undergone a biopsy +/- excision, defined as: 1/ [% of benign lesions detected with multiparametric analysis in bone scintigraphy].
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start11 Sep 2023
- Primary completion10 Dec 2026 (estimated)
- Study completion10 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LesionStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- People with indeterminate solitary bone lesions on conventional imaging, for whom a biopsy or surgery is scheduled
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Achraf BAHLOUL, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934994
- Sponsor's protocol ID
- 2022PI051
- Acronym
- MUSIC
- Status last verified
- Jun 2026
- First submitted
- 28 Mar 2023
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of MUltiparametric Analysis in Bone Scintigraphy for the Characterisation of Solitary Bone Lesions Whose Malignant Origin Cannot be Excluded on Conventional Imaging
- ClinicalTrials.gov ID
- NCT05934994
- Acronym / sponsor ID
- MUSIC / 2022PI051
- Conditions
- Bone Lesion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 10 Jan 2027 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of the study is that non-invasive Single photon emission computed tomography (SPECT-CT) bone scintigraphy makes it possible to better characterize solitary bone lesions, in particular the exclusion of their malignancy in order to avoid unnecessary biopsy and possible complications for the patient.
Detailed description
Bone scintigraphy includes 3 stages: study of perfusion then of early tissue uptake and finally of late bone fixation.
Hyperactivity of malignant bone lesions at the 3 stages of bone scintigraphy has been reported, but on planar scintigraphic images not allowing precise anatomical localization of the lesions.
Currently, the generalization of SPECT-CT (Single Photon Emission Computed Tomography) combined with Tomodensitometry) acquisition thanks to the deployment of semiconductor cameras, makes it possible to carry out a multiparametric analysis of bone lesions with quantification of the intensity of the signal expressed in SUVmax (Standard Uptake Value maximum) at the 3 times of the scintigraphy
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- People with indeterminate solitary bone lesions on conventional imaging, for whom a biopsy or surgery is scheduled
| Arm | Type | Receives |
|---|---|---|
| Patients with undetermined solitary bone lesions | Experimental | Other: Bone scanAll patients with indeterminate solitary bone lesions undetermined on conventional imaging for whom a biopsy or excision is scheduled, will be able to participate in the study. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Person, having received complete information on the organization of the research and having signed the informed consent and:
- Patient with an indeterminate solitary bone lesion on conventional imaging, for which an indication for biopsy +/- excision is planned.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone scanAlso: Bone scan in single photon emission computed tomographythe bone scintigraphy will include 3 stages: study of perfusion then early tissue uptake and finally late bone fixation | Other | Patients with undetermined solitary bone lesions |
Primary outcome
Assess the diagnostic performance of the Time To Peak parameter
Time frame: 24 hours
Sensitivity, specificity, positive predictive value and negative predictive value of the dynamic parameter Time-to-peak to characterize a benign lesion. The Time-To-Peak is defined by the time to reach the SUVmax peak, i.e. the top of the perfusion curve. The benign character is defined by criteria of biopathology at the biopsy +/- surgery.
3 secondary outcomes
To evaluate the diagnostic performance of the Standard Uptake Value max at the early stage (2nd stage) in bone scintigraphy in the evaluation of the benign nature of indeterminate solitary bone lesions on conventional imaging.
Time frame: 24 hours
o evaluate the diagnostic performance of the Standard Uptake Value max at the early stage (3 rd stage) in bone scintigraphy in the evaluation of the benign nature of indeterminate solitary bone lesions on conventional imaging.
Time frame: 24 hours
Evaluate the impact of multiparametric analysis (combination of Time-To-Peak, Standard Uptake Value max early and late) in the classification of solitary bone lesions in bone scintigraphy.
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone scan in people with Bone Lesion, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ACHRAF BAHLOUL, MD, MSc (383154003 ext. +33, a.bahloul@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the diagnostic performance of the Time To Peak parameter (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.