Stereotactic RadiosurgeryNCT05369689
Stereotactic Radiosurgery Prognosis Assessment for Spinal Tumors Based on Radiomics
An observational study of Stereotactic Radiosurgery and Spinal Tumor, run by Zhuang Hongqing at 1 site in China.
Trial summary
This study aims to assess multimodal Radiomics-based prediction model for prognostic prediction in spinal tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stereotactic Radiosurgery, Spinal Tumor, Radiomics
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 1 Jun 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had spinal tumors and completed CT, MRI, PET-CT examination before and after stereotactic radiosurgery.
Who may be able to join
- A diagnosis of spinal tumors for which SBRT is appropriate Karnofsky Performance Status >60 Life expectancy of at least 3 months No contraindication to undergoing MR imaging Age >18 Complete the CT MRI or PET-CT examination before and after treatment Accept stereotactic radiosurgery
Who cannot join
- Subjects unable to undergo MRI (includes non-MRI compatible material or devices and severe claustrophobia) Subjects with prior procedural intervention to the involved vertebral body that would result in artifact (kyphoplasty, screw and/or rod placement); minimally invasive surgery without instrumentation of the involved vertebral body and instrumentation immediately above or below the index lesion is allowed.
- Subjects with spinal cord compression; minimally invasive "separation" surgery to first resect the epidural component is allowed Pregnant or breast-feeding women Allergy to standard IV contrast agents used in MRI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Radiation Oncology Cancer Center, Peking University Third Hospital 49# North Garden Rd.,Haidian Dist.
Beijing, Beijing Municipality, 100191
About this study
This study aims to assess multimodal Radiomics-based prediction model for prognostic prediction in spinal tumors.
Read the detailed description
Sensitivity for prediction recurrence and survival of currently available prognostic scores is limited. This study proposes to establish a multimodal radiomics model for identifying tumor recurrence and prognostic prediction of spinal tumors. The study will investigate the relationship between the radiomics and the tumor microenvironment. The study includes the construction of multimodal radiomics-based prediction model and the validation of the prediction model.
- Conditions
- Stereotactic Radiosurgery, Spinal Tumor, Radiomics, Prognosis
- Being tested
- No interventions
- Medical subject headings
- Spinal Cord Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
As this is a prognosis evaluation study, there are no interventions.
| Study group | Role | What they receive |
|---|---|---|
| spinal tumors, CT, MRI, PET-CT stereotactic radiosurgery | Patients who had spinal tumors and completed the CT, MRI or PET-CT examination before and after stereotactic radiosurgery. Receives: Other: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression-free survival
Measured: 1 years
Secondary outcomes (4)
Overall survival (OS)
defined as the time from the beginning of diagnosis of spinal tumors to the death with any causes
Measured: 1 years
ORR
objective response rate
Measured: 3 months
DCR
disease control rate
Measured: 3 months
Recurrence free survival (RFS)
defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stereotactic RadiosurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Zhuang Hongqing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhuang Hongqing, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369689
- Sponsor's protocol ID
- SBRTradiomics
- Status last verified
- May 2022
- First submitted
- 7 May 2022
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Radiosurgery Prognosis Assessment for Spinal Tumors Based on Radiomics
- ClinicalTrials.gov ID
- NCT05369689
- Acronym / sponsor ID
- SBRTradiomics
- Conditions
- Stereotactic Radiosurgery, Spinal Tumor, Radiomics, Prognosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zhuang HongqingUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess multimodal Radiomics-based prediction model for prognostic prediction in spinal tumors.
Detailed description
Sensitivity for prediction recurrence and survival of currently available prognostic scores is limited. This study proposes to establish a multimodal radiomics model for identifying tumor recurrence and prognostic prediction of spinal tumors. The study will investigate the relationship between the radiomics and the tumor microenvironment. The study includes the construction of multimodal radiomics-based prediction model and the validation of the prediction model.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| spinal tumors, CT, MRI, PET-CT stereotactic radiosurgery | – | Other: No interventionsPatients who had spinal tumors and completed the CT, MRI or PET-CT examination before and after stereotactic radiosurgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had spinal tumors and completed CT, MRI, PET-CT examination before and after stereotactic radiosurgery.
Key inclusion criteria (1 listed)
- A diagnosis of spinal tumors for which SBRT is appropriate Karnofsky Performance Status >60 Life expectancy of at least 3 months No contraindication to undergoing MR imaging Age >18 Complete the CT MRI or PET-CT examination before and after treatment Accept stereotactic radiosurgery
Key exclusion criteria (2 listed)
- Subjects unable to undergo MRI (includes non-MRI compatible material or devices and severe claustrophobia) Subjects with prior procedural intervention to the involved vertebral body that would result in artifact (kyphoplasty, screw and/or rod placement); minimally invasive surgery without instrumentation of the involved vertebral body and instrumentation immediately above or below the index lesion is allowed.
- Subjects with spinal cord compression; minimally invasive "separation" surgery to first resect the epidural component is allowed Pregnant or breast-feeding women Allergy to standard IV contrast agents used in MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionsAs this is a prognosis evaluation study, there are no interventions. | Other | spinal tumors, CT, MRI, PET-CT stereotactic radiosurgery |
Primary outcome
PFS
Time frame: 1 years
progression-free survival
4 secondary outcomes
Overall survival (OS)
Time frame: 1 years
ORR
Time frame: 3 months
DCR
Time frame: 3 months
Recurrence free survival (RFS)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stereotactic Radiosurgery and Spinal Tumor, run by Zhuang Hongqing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongqing zhuang (82264910, hongqingzhuang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.