An observational study in Bone Neoplasm of Vertebral Column, Chordoma and Chondrosarcoma, sponsored by Leiden University Medical Center. Recruiting at 2 sites in Netherlands. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Leiden University Medical Center · Observational
Rationale: Chordomas and chondrosarcomas located in the axial skeleton are malignant neoplasms of bone. These tumors share the same clinical challenges, as the effect of the disease is more a function of their local aggressiveness than their tendency to metastasize (20% metastasize). The local aggressive behavior can cause debilitating morbidity and mortality by destruction of nearby located critical neurovascular structures. Imaging has, in addition to histopathology, a role in diagnosis and in guiding (neo)adjuvant and definitive treatment. Despite the low sensitivity to radiotherapy, proton radiotherapy has been successfully used as an adjunct to resection or as definitive treatment for aggressive chordomas and chondrosarcomas, making it a standard indication for proton therapy in the Netherlands.
Chordomas and chondrosarcomas consist, especially after previous therapy, of non-viable and viable tumor components. Identification of these viable components by functional imaging is important to determine the effect of previous therapy, as change in total tumor volume occurs more than 200 days after change of functional imaging parameters.
Objective: The main objective of this study is to determine if functional MRI parameters change within 6 months, and earlier than volumetric changes after start of proton beam therapy. This would allow timely differentiation between affected and unaffected (viable) tumor components, which can be used for therapy adjustment.
Secondary objectives: Determine which set of parameters (PET-CT and secondary MRI) can predict clinical outcome (tumor specific mortality, development of metastases, morbidity secondary to tumor activity and morbidity secondary to treatment); determine what type of imaging can accurately identify viable tumor nodules relative to critical anatomical structures; improving understanding of relevance of changing imaging parameters by correlating these with resected tumor.
Study design: Prospective cohort study Study population: LUMC patients diagnosed with primary or recurrent chordoma or chondrosarcoma in the axial skeleton. A number of 20 new patients per year is expected.
Main study parameters: Volumetric and functional MR imaging parameters including permeability parameters.
Secondary parameters are generated by PET-CT (SUV, MTV and TLG), MR (perfusion, permeability and diffusion), therapy (proton beam dose mapping, surgery) and clinical outcome. End points are disease specific survival, progression free survival (including development of metastases), side effects of treatment, and functional outcome (see CRF). In patients who are treated with surgical resection following neo-adjuvant therapy, the surgical specimen will be correlated with imaging findings.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Treatment and clinical management will not be affected in this study, thus the additional burden, risks, and benefits associated with participation in this study are minimal.
Two extra MRI and one PET-CT examination will be planned during proton therapy.
68 studies on the registry are indexed under Chordoma; 15 are open to participants now.
This study's planned enrollment of 40 is below the median of 71 across 16 observational studies indexed under Chordoma.
Browse Chordoma studies →Leiden University Medical Center is the lead sponsor of 334 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients referred to HollandPTC, 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vp(max), Vp(min)
MRI permeability parameter - tumor plasma volume
Time frame: At inclusion, 4 and 8 weeks, 5,11,17 and 23 months after the start date of proton therapy treatment
Rel Enhancement (%)
MRI perfusion parameter showing the signal enhancement of a pixel of certain dynamic relative to that same pixel in the reference dynamic. The reference dynamic is normally the first, pre-contrast dynamic.
Time frame: At inclusion, 4 and 8 weeks, 5,11,17 and 23 months after the start date of proton therapy treatment
Max Enhancement (%)
MRI perfusion parameter showing difference between peak intensity S1 and S0.
Time frame: At inclusion, 4 and 8 weeks, 5,11,17 and 23 months after the start date of proton therapy treatment
Max Rel Enhancement (%)
MRI perfusion parameter showing maximum of all relative enhancements over all dynamics
Time frame: At inclusion, 4 and 8 weeks, 5,11,17 and 23 months after the start date of proton therapy treatment
Time of arrival T0 (s)
MRI perfusion parameter showing time at which the signal intensity increases for at least 20% compared to the baseline (referred to as initial signal intensity S0). The baseline is the average of the signal intensities of all timepoints before the contrast uptake starts.
Time frame: At inclusion, 4 and 8 weeks, 5,11,17 and 23 months after the start date of proton therapy treatment
Time To Peak (s)
MRI perfusion parameter showing time till contrast agent bolus reaches peak intensity
Time frame: At inclusion, 4 and 8 weeks, 5,11,17 and 23 months after the start date of proton therapy treatment
Wash In Rate (sˉ¹)
MRI perfusion parameter showing maximum slope between T0 and time of peak intensity T1
Time frame: At inclusion, 4 and 8 weeks, 5,11,17 and 23 months after the start date of proton therapy treatment
Wash Out Rate (sˉ¹)
MRI perfusion parameter showing maximum slope between time of peak intensity T1 and the end of the measurement
Time frame: At inclusion, 4 and 8 weeks, 5,11,17 and 23 months after the start date of proton therapy treatment
Brevity of Enhancement (s)
MRI perfusion parameter showing time between point of maximum wash in rate and maximum wash out rate.
Time frame: At inclusion, 4 and 8 weeks, 5,11,17 and 23 months after the start date of proton therapy treatment
Ktrans
MRI permeability parameter - transfer constant between blood plasma and Extravascular Extracellular Space (EES), also called vascular permeability
Time frame: At inclusion, 4 and 8 weeks, 5,11,17 and 23 months after the start date of proton therapy treatment
kep
MRI permeability parameter showing rate between EES and blood plasma (also called Tracer Efflux Rate)
Time frame: At inclusion, 4 and 8 weeks, 5,11,17 and 23 months after the start date of proton therapy treatment
Ve
MRI permeability parameter showing Extravascular Volume fraction (Leakage space); defined as Ktrans / kep
Time frame: At inclusion, 4 and 8 weeks, 5,11,17 and 23 months after the start date of proton therapy treatment
Area under the curve (AUC)
MRI permeability and perfusion parameter showing area Under the Curve of all time curves
Time frame: At inclusion, 4 and 8 weeks, 5,11,17 and 23 months after the start date of proton therapy treatment
mean ADC, Min ADC, Max ADC
MRI diffusion parameters
Time frame: At inclusion, 4 and 8 weeks, 5,11,17 and 23 months after the start date of proton therapy treatment
SUV
Standard uptake value extracted from PET-CT imaging
Time frame: At inclusion and and 11 months following the start date fo proton therapy
MTV
Metabolic tumor volume extracted from PET-CT imaging
Time frame: At inclusion and and 11 months following the start date fo proton therapy
TLG
Total lesion glycolysis extracted from PET-CT imaging
Time frame: At inclusion and and 11 months following the start date fo proton therapy
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