NeoplasmsNCT05918536
Orthopedic Oncology Surgery: Navigation, Intraoperative Imaging and Virtual Reality
An observational study of Neoplasms and Muscle Neoplasm, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
Noninterventional, prospective study of patients operated on for musculoskeletal neoplasms designed to evaluate the quality of surgical margins achievable with the use of navigated Intraoperative CT Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neoplasms, Muscle Neoplasm
- What is being tested?
- evaluate the quality of surgical margins achievable with the use of navigated Intraoperative CT
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 17 May 2022to 17 Nov 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with primary and secondary cancers of the musculoskeletal system with estimated survival greater than one year who are candidates for bone resection surgery or wide excision of soft tissue lesion and/or radio and chemotherapy treatments
Who may be able to join
- Age: no limit
- Patients with musculoskeletal neoplasms predominantly in complex sites
- Patients who will have to undergo surgical resection/amputation for the management of their clinical case
- Preparation of preoperative planning discussed at DMT
- Surgery performed with the aid of Intraoperative CT Navigated
- Written informed consent
Who cannot join
- Inability to perform pre-post treatment assessment
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
"Regina Elena" National Cancer Institute
Rome, 00144
Roberto Biagini, MD, ND, roberto.biagini@ifo.it
About this study
Noninterventional, prospective study of patients operated on for musculoskeletal neoplasms designed to evaluate the quality of surgical margins achievable with the use of navigated Intraoperative CT
- Conditions
- Neoplasms, Muscle Neoplasm
- Being tested
- evaluate the quality of surgical margins achievable with the use of navigated Intraoperative CT
- Medical subject headings
- Neoplasms, Muscle Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluate the quality of surgical margins achievable with the use of navigated Intraoperative CTDiagnostic test
Noninterventional, prospective study of patients operated on for musculoskeletal neoplasms designed to evaluate the quality of surgical margins achievable with the use of navigated Intraoperative CT
| Study group | Role | What they receive |
|---|---|---|
| Popolation | Not described Receives: Diagnostic Test: evaluate the quality of surgical margins achievable with the use of navigated Intraoperative CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
To evaluate the quality of the Surgical Margin in terms of the percentage of oncologically adequate resections, in patients with Musculoskeletal neoplasms undergoing navigated resection surgery with Intraoperative CT
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start17 May 2022
- Primary completion17 May 2025 (estimated)
- Study completion17 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Policlinico Umberto I, I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918536
- Sponsor's protocol ID
- RS1686/22
- Status last verified
- Jun 2023
- First submitted
- 28 Mar 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthopedic Oncology Surgery: Navigation, Intraoperative Imaging and Virtual Reality
- ClinicalTrials.gov ID
- NCT05918536
- Acronym / sponsor ID
- RS1686/22
- Conditions
- Neoplasms, Muscle Neoplasm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Collaborators
- Azienda Policlinico Umberto I, I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Study start
- 17 May 2022 (actual)
- Primary completion
- 17 May 2025 (estimated)
- Study completion
- 17 Nov 2025 (estimated)
- First posted
- 26 Jun 2023 (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.
Noninterventional, prospective study of patients operated on for musculoskeletal neoplasms designed to evaluate the quality of surgical margins achievable with the use of navigated Intraoperative CT
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Popolation | – | Diagnostic Test: evaluate the quality of surgical margins achievable with the use of navigated Intraoperative CT |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with primary and secondary cancers of the musculoskeletal system with estimated survival greater than one year who are candidates for bone resection surgery or wide excision of soft tissue lesion and/or radio and chemotherapy treatments
Key inclusion criteria (6 listed)
- Age: no limit
- Patients with musculoskeletal neoplasms predominantly in complex sites
- Patients who will have to undergo surgical resection/amputation for the management of their clinical case
- Preparation of preoperative planning discussed at DMT
- Surgery performed with the aid of Intraoperative CT Navigated
Key exclusion criteria (1 listed)
- Inability to perform pre-post treatment assessment
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 |
|---|---|---|
| evaluate the quality of surgical margins achievable with the use of navigated Intraoperative CTNoninterventional, prospective study of patients operated on for musculoskeletal neoplasms designed to evaluate the quality of surgical margins achievable with the use of navigated Intraoperative CT | Diagnostic test | Popolation |
Primary outcome
Quality of life
Time frame: Baseline
To evaluate the quality of the Surgical Margin in terms of the percentage of oncologically adequate resections, in patients with Musculoskeletal neoplasms undergoing navigated resection surgery with Intraoperative CT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Neoplasms and Muscle Neoplasm, run by Regina Elena Cancer Institute at 1 site in Italy.
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 6 inclusion and 1 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 26 Jun 2023. 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: Baseline). 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 26 Jun 2023.