Osteoarticular Tumor Characterization by Advanced Imaging

NCT ID: NCT02895633

Last Updated: 2016-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1090 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2020-11-30

Brief Summary

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The purpose is to compare and evaluate multiple functional imaging methods (perfusion, diffusion, spectroscopy) for initial benign/malignant characterization of osteoarticular tumors and to determine which method or which association of methods could improve non invasive tissue characterization.

Secondary purposes are:

* to determine a possible correlation between some parameters and the histological grade (FNCLCC)
* to suggest a coherent diagnostic imaging approach for osteoarticular tumors.

The ancillary study will enroll patients needing radiological tumor follow-up. The purpose is to identify tools for evaluation of tumor activity and therapeutic response before modification of morpho-volumetric data.

Detailed Description

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Patients refered for the initial evaluation of suspected osteoarticular masses will be included in this study after signing an informed consent.

Histologic analysis will be used as a gold standard.

The following imaging techniques will be evaluated:

* contrast enhanced ultrasonography
* Low dose CT perfusion
* Magnetic resonance perfusion
* Diffusion weighted imaging
* Magnetic resonance proton spectroscopy

Conditions

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Bone Tumor Soft Tissue Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with bone or peripheral soft-tissue tumor

Group Type EXPERIMENTAL

Ecography

Intervention Type OTHER

Standard Doppler ultrasound and perfusion imaging after injection of Sonovue

CT scan

Intervention Type OTHER

With injection of Iomeron 400

MRI

Intervention Type OTHER

With injection of gadolinium (Multihance)

Interventions

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Ecography

Standard Doppler ultrasound and perfusion imaging after injection of Sonovue

Intervention Type OTHER

CT scan

With injection of Iomeron 400

Intervention Type OTHER

MRI

With injection of gadolinium (Multihance)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients examined for initial assessment of bone or peripheral soft-tissue primitive tumor
* patients with normal awareness level
* patients having signed informed consent

Exclusion Criteria

* pregnant women
* persons deprived of liberty
* persons under legal protection or unable to give informed consent
* persons in life-threatening emergency
* allergy to Sonovue, iodinated contrast media or gadolinium chelates
* risk of pregnancy
* breastfeeding women
* acute coronary syndrome or unstable ischemic cardiopathy (ban on injection of contrast agent for CT scan)
* renal failure (ban on injection of contrast agent for MRI and CT scan)
* contraindication to MRI
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pedro Augusto GONDIM TEIXEIRA

Role: PRINCIPAL_INVESTIGATOR

Service d'Imagerie Guilloz, CHRU Nancy

Locations

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Service d'Imagerie Guilloz, CHRU Nancy

Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pedro Augusto GONDIM TEIXEIRA

Role: CONTACT

References

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Ribeiro GJ, Gillet R, Hossu G, Trinh JM, Euxibie E, Sirveaux F, Blum A, Teixeira PAG. Solitary bone tumor imaging reporting and data system (BTI-RADS): initial assessment of a systematic imaging evaluation and comprehensive reporting method. Eur Radiol. 2021 Oct;31(10):7637-7652. doi: 10.1007/s00330-021-07745-9. Epub 2021 Mar 25.

Reference Type DERIVED
PMID: 33765161 (View on PubMed)

Other Identifiers

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2009-A00758-49

Identifier Type: -

Identifier Source: org_study_id

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