Actively Recruiting

Age: 50Years +
All Genders
ID04832620

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

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

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

Long-term Monitoring

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

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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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