Actively Recruiting
Defining Optimal Imaging Strategies for Diagnosis, Treatment, and Treatment Evaluation of Chordomas and Chondrosarcomas of the Axial Skeleton
Led by Leiden University Medical Center · Updated on 2023-11-18
40
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
Sponsors
L
Leiden University Medical Center
Lead Sponsor
H
HollandPTC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying chordomas and chondrosarcomas, which are malignant bone tumors located in the axial skeleton including the clivus, spine, and sacrum. These tumors mainly cause problems due to their local aggressive growth rather than spreading to other parts of the body. The study focuses on using advanced imaging techniques to evaluate the changes in tumor components early during proton beam therapy, aiming to improve treatment decisions and outcomes. This is a prospective cohort study involving patients with these tumors who are treated at Leiden University Medical Center. Participants will undergo standard proton beam therapy for their tumor treatment. During the therapy, additional imaging assessments will be performed, including two extra MRI scans and one PET-CT scan. These functional imaging techniques will measure parameters such as tumor permeability and activity to detect changes within six months of starting treatment. The study will also compare imaging findings with surgical specimens in patients undergoing surgery after neo-adjuvant therapy to better understand tumor viability. Throughout the study, participants will have imaging and clinical evaluations at multiple time points: at inclusion, 4 and 8 weeks, and then at 5, 11, 17, and 23 months after starting proton therapy. Researchers will monitor functional MRI parameters and PET-CT measures, as well as clinical outcomes like survival, tumor progression, metastasis development, and treatment side effects. Data from imaging, treatment details, and clinical follow-up will be collected to assess how early imaging changes relate to patient outcomes. Participation involves minimal additional risk, as treatment and care remain standard.
CONDITIONS
Brief Title
Image Assisted Optimization of Proton Radiation Therapy in Chordomas and Chondrosarcomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically diagnosed with primary or recurrent chordoma or chondrosarcoma in the axial skeleton (clivus, spine and sacrum)
- Accepted for standard proton beam therapy
- Age 50 years or older
You will not qualify if you...
- Diagnosis other than chordoma or chondrosarcoma
- Patient refuses any part of the standard treatment protocol
- Patient refuses MRI due to claustrophobia
- Presence of MRI incompatible implants
- Incapacitated patients
- Patient does not allow coded data to be used for analysis
- Age under 50 years
- Lesion size less than 1 cm
- Patients with WHO grade 3 or higher tumors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 23 months
Participants undergo imaging assessments to evaluate tumor characteristics before, during, and after proton radiation therapy.
Multiple imaging assessments at inclusion, 4 and 8 weeks, and 5, 11, 17, and 23 months after starting proton therapy
Duration - Up to 23 months
Participants are observed over time to monitor tumor response and treatment effects through imaging.
Additional imaging assessments at inclusion and 11 months after starting proton therapy
Trial Site Locations
Total: 2 locations
1
HollandPTC
Delft, South Holland, Netherlands, 2629 JH
Actively Recruiting
2
LUMC
Leiden, South Holland, Netherlands, 2333 ZA
Actively Recruiting
Research Team
S
Stijn Krol, dr. PhD
V
Vesna Miladinovic
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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