NCT02895633

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,090

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

September 12, 2016

Status Verified

September 1, 2016

Enrollment Period

9 years

First QC Date

September 5, 2016

Last Update Submit

September 5, 2016

Conditions

Bone TumorSoft Tissue Tumor

Keywords

MR imagingDiffusion weighted imagingMR proton spectroscopyCT perfusionContrast enhanced ultrasound

Outcome Measures

Primary Outcomes (19)

  • Contrast enhancement in echography: yes or no

    baseline

  • Contrast enhancement curve (absent, slow or fast) in echography

    baseline

  • Maximal intensity of enhancement peak in echography

    baseline

  • Mean transit time of enhancement in echography

    baseline

  • Gradient of contrast enhancement curve in echography

    baseline

  • Vascularization (dynamic analysis) in CT scanner

    * 0: absent * 1: low (\< 20UH) * 2: \> 20 UH without new blood vessels * 3: \> 20 UH and/or with new blood vessels

    baseline

  • Contrast enhancement curve (absent, slow or fast) in CT scanner

    baseline

  • Maximal intensity of enhancement peak in CT scanner

    baseline

  • Mean transit time of enhancement in CT scanner

    baseline

  • Gradient of contrast enhancement curve in CT scanner

    baseline

  • Contrast enhancement curve (absent, slow or fast) in MRI

    baseline

  • Maximal intensity of enhancement peak in MRI

    baseline

  • Mean transit time of enhancement in MRI

    baseline

  • Gradient of contrast enhancement curve in MRI

    baseline

  • Choline peak in magnetic resonance spectroscopy

    Choline presence was defined as a clear metabolite peak at 3.2 ppm

    baseline

  • Apparent diffusion coefficient (ADC) in MR diffusion weighted imaging

    ADC value in mm2/s

    baseline

  • Area under the perfusion curve in MRI

    baseline

  • Perfusion curve gradient in MRI

    baseline

  • Perfusion time-to-peak in MRI

    baseline

Study Arms (1)

Patients with bone or peripheral soft-tissue tumor

EXPERIMENTAL
Other: EcographyOther: CT scanOther: MRI

Interventions

EcographyOTHER

Standard Doppler ultrasound and perfusion imaging after injection of Sonovue

Patients with bone or peripheral soft-tissue tumor
CT scanOTHER

With injection of Iomeron 400

Patients with bone or peripheral soft-tissue tumor
MRIOTHER

With injection of gadolinium (Multihance)

Patients with bone or peripheral soft-tissue tumor

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Imagerie Guilloz, CHRU Nancy

Nancy, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33765161DERIVED

MeSH Terms

Conditions

Bone NeoplasmsSoft Tissue Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Study Officials

  • Pedro Augusto GONDIM TEIXEIRA

    Service d'Imagerie Guilloz, CHRU Nancy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro Augusto GONDIM TEIXEIRA

CONTACT

ped_gt@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2016

First Posted

September 12, 2016

Study Start

November 1, 2009

Primary Completion

November 1, 2018

Study Completion

November 1, 2020

Last Updated

September 12, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)