Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04832620
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2021-03-29
Brief Title:
Image Assisted Optimization of Proton Radiation Therapy in Chordomas and Chondrosarcomas
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
Defining Optimal Imaging Strategies for Diagnosis Treatment and Treatment Evaluation of Chordomas and Chondrosarcomas of the Axial Skeleton
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHIPT
Brief Summary:
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 neoadjuvant 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None