Contribution of MUltiparametric Analysis in Bone Scintigraphy for the Characterisation of Solitary Bone Lesions

NCT ID: NCT05934994

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-11
• Study Completion Date: 2027-01-10

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with undetermined solitary bone lesions

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.

Group Type: EXPERIMENTAL

Bone scan

Intervention Type: OTHER

the bone scintigraphy will include 3 stages: study of perfusion then early tissue uptake and finally late bone fixation

Interventions

Bone scan

the bone scintigraphy will include 3 stages: study of perfusion then early tissue uptake and finally late bone fixation

Intervention Type: OTHER

Other Intervention Names

Bone scan in single photon emission computed tomography

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Achraf BAHLOUL

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHRU Nancy

Vandœuvre-lès-Nancy, , France

Site Status: RECRUITING

Countries

France

Central Contacts

ACHRAF BAHLOUL, MD, MSc

Role: CONTACT

a.bahloul@chru-nancy.fr

383154003 ext. +33

VERONIQUE ROCH, MSc

Role: CONTACT

v.roch@chru-nancy.fr

383154276 ext. +33

Facility Contacts

VERONIQUE ROCH, MSc

Role: primary

v.roch@chru-nancy.fr

0383154276 ext. +33

Other Identifiers

2022PI051

Identifier Type: -

Identifier Source: org_study_id