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

Defining optimal imaging strategies for diagnosis, treatment, and treatment evaluation of chordomas and chondrosarcomas of the axial skeleton - Optimization of chordoma and chondrosarcoma proton therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54229

Enrollment

Registered

2021-02-02

Start date

2021-03-15

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone tumor

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Primary parameters are MRI mean and max tumor plasma volumes Vp.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results