Show that functional MR tumor plasma volume parameters Vp,max and Vp,mean change significantly within 1-6months following start of proton beam radiotherapy of chordoma.
ID
Source
Brief title
Condition
- Skeletal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary parameters are MRI mean and max tumor plasma volumes Vp.
Secondary outcome
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.
Background summary
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. [1] Study hypothesis is that these viable tumor nodules detected
with functional imaging can be used to
direct proton therapy, which is characterized by its accurate target volume, in
the future.
[1] Santos P, Peck KK, Arevalo-Perez J, Karimi S, Lis E, Yamada Y, Holodny AI,
Lyo J, T1-Weighted Dynamic
Contrast-Enhanced MR Perfusion Imaging Characterizes Tumor Response to
Radiation Therapy in Chordoma, http://
dx.doi.org/10.3174/ajnr.A5383
Study objective
Show that functional MR tumor plasma volume parameters Vp,max and Vp,mean
change significantly within 1-6
months following start of proton beam radiotherapy of chordoma.
Study design
The design of this study is a prospective cohort study.
Study burden and risks
Extra MRI and PET-CT examinations will be planned during proton therapy. As
this extra imaging is performed in
HollandPTC during treatment there will be no additional burden on patient
regarding mobility. However, additional
scanning might represent an additional burden to the patient as he/she will
receive extra dose (see Appendix A) and
the scanning procedure will add up to 3 extra hours spent at the HollandPTC
compared to the standard protocol.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
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.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04832620 |
| CCMO | NL73476.058.20 |