Solid Tumor, AdultIMPRESSNCT05252975
Improving Cyberknife Spinal Stereotactic Radiotherapy in Difficult to Treat Cases (IMPRESS)
A study testing Setup and Imaging for at CT radiation planning in people with Solid Tumor, Adult, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
A prospective study evaluating prone and supine positioning for radiation planning of spine Cyberknife radiotherapy treatment. Patients with tumours in which PTV coverage is compromised due to tumour geography, including posteriorly based lesions in the vertebral column and close proximity to organ at risk (other than… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- Setup and Imaging for at CT radiation planning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2020to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Patients undergoing Cyberknife treatment to spinal metastasis
- >18 years of age
- Thoracic, lumbar and sacral spinal metastasis
- Patients suitable to undergo radiotherapy planning CT scans in the prone position (treating physician assessed as having spinal stability).
- All solid tumour types will be eligible
Who cannot join
- • Primary spinal tumours
- Vertebral disease resulting in unstable spinal vertebrae
- Cervical tumours (patients will be unable to have a thermoplastic shell made for the prone position).
- Patients with significant pain on prone lying (to be assessed by physician prior to consent)
- Bilsky epidural score of 2 or greater (see appendix 1)
- Pre-existing musculoskeletal chronic back medical diagnoses that would preclude CT scanning in the prone position.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PY
Bianca Peet, 02086613566, bianca.peet@rmh.nhs.uk
About this study
A prospective study evaluating prone and supine positioning for radiation planning of spine Cyberknife radiotherapy treatment. Patients with tumours in which PTV coverage is compromised due to tumour geography, including posteriorly based lesions in the vertebral column and close proximity to organ at risk (other than the spinal cord).
Read the detailed description
This is a prospective, non-randomised radiotherapy planning study.
Subsets of patients with specific tumour and anatomical characteristics will benefit from improved PTV prescription isodose coverage, reduced spinal cord dose, and organs at risk dose by undergoing either prone or supine setup, planning and treatment. Both prone and supine CT radiotherapy planning scans for patients undergoing spine SBRT treatment will undergo comparison of radiotherapy plans to guide recommendation of prone treatment for future patients.
Patients continue to receive treatment in the proposed position as recommended y their treating physician.
- Conditions
- Solid Tumor, Adult
- Being tested
- Setup and Imaging for at CT radiation planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Setup and Imaging for at CT radiation planningOther
Patients will undergo an additional CT scan acquisition at CT radiotherapy planning in order that all participating patients have a prone and supine CT scan available to compare radiation therapy plans.
| Study group | Role | What they receive |
|---|---|---|
| Supine | Active comparator | Patients undergo supine setup and imaging for radiation planning Receives: Other: Setup and Imaging for at CT radiation planning |
| Prone | Experimental | Patients undergo prone setup and imaging for radiation planning Receives: Other: Setup and Imaging for at CT radiation planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTV isodose coverage
To compare the PTV coverage of radiotherapy plans delivered in prone and supine positions
Measured: Through study completion, an average of 1 year.
Secondary outcomes (4)
Organs at risk dose
Compare organs at risk dose between supine and prone positioning.
Measured: Immediate
Comfort scores
Evaluate comfort scores in both treatment positions (supine and prone)
Measured: Immediate
CT and MRI registration
Evaluate CT and MRI registration on tumour target delineation
Measured: Immediate
Treatment time duration
Treatment time duration
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Jul 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252975
- Sponsor's protocol ID
- CCR 5216
- Acronym
- IMPRESS
- Status last verified
- Feb 2022
- First submitted
- 27 Jan 2022
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cyberknife Spinal Stereotactic Radiotherapy in Difficult to Treat Cases (IMPRESS)
- ClinicalTrials.gov ID
- NCT05252975
- Acronym / sponsor ID
- IMPRESS / CCR 5216
- Conditions
- Solid Tumor, Adult
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 23 Feb 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.
A prospective study evaluating prone and supine positioning for radiation planning of spine Cyberknife radiotherapy treatment. Patients with tumours in which PTV coverage is compromised due to tumour geography, including posteriorly based lesions in the vertebral column and close proximity to organ at risk (other than the spinal cord).
Detailed description
This is a prospective, non-randomised radiotherapy planning study.
Subsets of patients with specific tumour and anatomical characteristics will benefit from improved PTV prescription isodose coverage, reduced spinal cord dose, and organs at risk dose by undergoing either prone or supine setup, planning and treatment. Both prone and supine CT radiotherapy planning scans for patients undergoing spine SBRT treatment will undergo comparison of radiotherapy plans to guide recommendation of prone treatment for future patients.
Patients continue to receive treatment in the proposed position as recommended y their treating physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supine | Active comparator | Other: Setup and Imaging for at CT radiation planningPatients undergo supine setup and imaging for radiation planning |
| Prone | Experimental | Other: Setup and Imaging for at CT radiation planningPatients undergo prone setup and imaging for radiation planning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Patients undergoing Cyberknife treatment to spinal metastasis
Key exclusion criteria (6 listed)
- • Primary spinal tumours
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 |
|---|---|---|
| Setup and Imaging for at CT radiation planningPatients will undergo an additional CT scan acquisition at CT radiotherapy planning in order that all participating patients have a prone and supine CT scan available to compare radiation therapy plans. | Other | Prone, Supine |
Primary outcome
PTV isodose coverage
Time frame: Through study completion, an average of 1 year.
To compare the PTV coverage of radiotherapy plans delivered in prone and supine positions
4 secondary outcomes
Organs at risk dose
Time frame: Immediate
Comfort scores
Time frame: Immediate
CT and MRI registration
Time frame: Immediate
Treatment time duration
Time frame: Immediate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Setup and Imaging for at CT radiation planning in people with Solid Tumor, Adult, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 Feb 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merina Ahmed (02086426011, merina.ahmed@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTV isodose coverage (time frame: Through study completion, an average of 1 year.). 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 23 Feb 2022.