Defining optimal imaging strategies for diagnosis, treatment, and treatment evaluation of chordomas and chondrosarcomas of the axial skeleto

Conditions: Bone tumor
10040778

Registration Number: NL-OMON54229

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria: referred to HPTC, or LUMC, or the Netherlands
Committee of Bone tumors, histologically diagnosed with primary or recurrent
chordoma or chondrosarcoma in the axial skeleton (clivus, spine and sacrum),
and accepted for standard proton beam therapy.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Diagnosis other than chordoma or chondrosarcoma is made.
- Patient refuses (parts) of the standard treatment protocol.
- Patient refuses MRI due to claustrophobia.
- Patient not suitable for MRI due to the presence of MRI incompatible implants.
- Incapacitated patients.
- Patient doesn*t allow coded data to be used for analysis.
- Patient is under 18 years of age.
- Lesion size less than 1cm.
- Patients with WHO 3 and higher.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary parameters are MRI mean and max tumor plasma volumes Vp.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are MRI perfusion AUC time-intensity curves, slopes, T1<br /><br>mapping, volumetric analysis,<br /><br>cellularity-mean ADC, Min ADC, Max ADC, permeability Ktrans, Kep, Kel, AUC.<br /><br>Evaluation of the soft tissue target<br /><br>volume will be correlated to quality of life parameters (function of cerebral<br /><br>nerves near skull base, lumbar and sacral<br /><br>roots in the sacrum). Following PET-CT parameters: SUVmax [gmL-1], SUVpeak<br /><br>[gmL-1], SUVmean [g*mL-1], MTV [ml], TLG [g], texture features parameters,<br /><br>along with progression free and disease specific survival.<br /><br>In patients who are treated with surgical resection following neo-adjuvant<br /><br>therapy, the surgical specimen will be<br /><br>correlated with imaging findings.</p><br>