NCT05934994

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Sep 2023Jan 2027

First Submitted

Initial submission to the registry

March 28, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 11, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2027

Expected
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

2.2 years

First QC Date

March 28, 2023

Last Update Submit

January 7, 2025

Conditions

Bone Lesion

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    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.

    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.

    24 hours

Study Arms (1)

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.

Other: Bone scan

Interventions

Bone scanOTHER

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

Also known as: Bone scan in single photon emission computed tomography
Patients with undetermined solitary bone lesions

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

Central Study Contacts

ACHRAF BAHLOUL, MD, MSc

CONTACT

383154003a.bahloul@chru-nancy.fr

VERONIQUE ROCH, MSc

CONTACT

383154276v.roch@chru-nancy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: People with indeterminate solitary bone lesions on conventional imaging, for whom a biopsy or surgery is scheduled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 28, 2023

First Posted

July 7, 2023

Study Start

September 11, 2023

Primary Completion

December 10, 2025

Study Completion (Estimated)

January 10, 2027

Last Updated

January 8, 2025

Record last verified: 2025-01

Locations

FR(1)