Sarcoma, EwingNCT06387485
A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning
A study testing 3D Printed Anatomic Model and CT/MRI in people with Sarcoma, Ewing and Chondrosarcoma, run by Ricoh USA, Inc. at 3 sites in United States.
Trial summary
This prospective, multi-center, randomized controlled study aims to assess the efficacy of utilizing 3D printed models in preoperative planning for the excision of tumors involving bony structures within the body. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Sarcoma, Ewing, Chondrosarcoma, Osteosarcoma
- What is being tested?
- 3D Printed Anatomic Model and CT/MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Mar 2024to 31 Jul 2027
- Phase
- Interventional
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must be at least 13 years of age.
- Subjects must have the ability to provide written informed consent.
- Subjects must have tumor(s) invading bone and requiring surgical excision including but not limited to craniomaxillofacial, spine, long bone, and pelvis.
- Subjects must be willing to have quality cross-sectional imaging that will allow for use to develop a 3D printed model.
Who cannot join
- Pregnant or nursing women.
- Subjects that have a serious systemic pathology.
- Subjects that have clotting disorders.
- Subjects that have uncontrolled hypertension.
- Subjects that are HIV-positive.
- Subjects that are unable to be randomized; i.e surgical team prefers to use either 3D model or standard cross-sectional imaging for surgical pre-planning.
- Subject anatomy has changed substantially since the date medical imaging from which the model is derived was obtained (as applicable).
- Subject is a poor surgical or poor study candidate which may include, any medical, social or psychological problem that could complicate the procedure.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43212
Rachel Herster, BS, 248-514-4490, rachel.herster@osumc.edu
- Recruiting
Kaiser Permanente Oakland Medical Center
Oakland, California, 94611
Rozhin Lak, 925-922-8575, Rozhin.X.Lak@kp.org
- Recruiting
William Beaumont University Hospital
Royal Oak, Michigan, 48073
Pamela Sloan, RN, CCRP, 248-551-6059, Pamela.Sloan@corewellheath.org
About this study
This prospective, multi-center, randomized controlled study aims to assess the efficacy of utilizing 3D printed models in preoperative planning for the excision of tumors involving bony structures within the body. The study is expected to last approximately 12 months and involve up to 150 subjects across up to 5 sites. Subjects will be randomized in a 1:1 ratio into either the experimental arm, utilizing 3D printed models and imaging, or the active comparator arm, using only imaging.
Primary endpoint: Operative time of surgical procedure.
Read more
Secondary endpoints: Reduction of blood loss, proportion of postoperative adverse events, and negative tumor margins.
Exploratory endpoints: Surgical planning ease, changes in surgical plan, and surgeon satisfaction.
- Conditions
- Sarcoma, Ewing, Chondrosarcoma, Osteosarcoma, Fibrous Histiocytoma, Fibrosarcoma
- Being tested
- 3D Printed Anatomic Model, CT/MRI
- Keywords
- bony tumor
- Medical subject headings
- Sarcoma, Ewing, Chondrosarcoma, Osteosarcoma, Histiocytoma, Benign Fibrous, Fibrosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Printed Anatomic ModelDevice
Patient-specific 3D printed anatomic model for pre-surgical planning
CT/MRIDiagnostic test
Standard imaging type for bony tumors
| Study group | Role | What they receive |
|---|---|---|
| Standard Imaging | Active comparator | Participants in this arm will undergo tumor excision with prior planning utilizing only Imaging (CT or MRI) without development of a 3D printed model Receives: Diagnostic Test: CT/MRI |
| 3D Printed Anatomic Model | Experimental | Participants in this arm will have tumors excised with prior planning utilizing 3D printed models and Imaging (CT or MRI). Receives: Device: 3D Printed Anatomic Model; Diagnostic Test: CT/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Operative time of surgical procedure based on incision and closure time
Measured: Incision to closure
Secondary outcomes (3)
Blood loss
Change in blood loss as determined by estimated blood loss and units of blood transfused (or blood products used) in mL.
Measured: Incision to closure
Adverse Events
The proportion of ER visits and post operative procedure related adverse events/complications as reported at the 90-day Follow-Up Chart Review.
Measured: Surgery to 90 days post-surgery
Tumor margin status
The proportion of negative tumor margins as determined by laboratory analysis.
Measured: Post-surgery (+3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Mar 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcoma, EwingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ricoh USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387485
- Sponsor's protocol ID
- SR-001
- Status last verified
- Feb 2026
- First submitted
- 18 Apr 2024
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning
- ClinicalTrials.gov ID
- NCT06387485
- Acronym / sponsor ID
- SR-001
- Conditions
- Sarcoma, Ewing, Chondrosarcoma, Osteosarcoma, Fibrous Histiocytoma, Fibrosarcoma
- Keywords
- bony tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ricoh USA, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 29 Apr 2024 (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 prospective, multi-center, randomized controlled study aims to assess the efficacy of utilizing 3D printed models in preoperative planning for the excision of tumors involving bony structures within the body. The study is expected to last approximately 12 months and involve up to 150 subjects across up to 5 sites. Subjects will be randomized in a 1:1 ratio into either the experimental arm, utilizing 3D printed models and imaging, or the active comparator arm, using only imaging.
Primary endpoint: Operative time of surgical procedure.
Secondary endpoints: Reduction of blood loss, proportion of postoperative adverse events, and negative tumor margins.
Exploratory endpoints: Surgical planning ease, changes in surgical plan, and surgeon satisfaction.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Imaging | Active comparator | Diagnostic Test: CT/MRIParticipants in this arm will undergo tumor excision with prior planning utilizing only Imaging (CT or MRI) without development of a 3D printed model |
| 3D Printed Anatomic Model | Experimental | Device: 3D Printed Anatomic Model, Diagnostic Test: CT/MRIParticipants in this arm will have tumors excised with prior planning utilizing 3D printed models and Imaging (CT or MRI). |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must be at least 13 years of age.
- Subjects must have the ability to provide written informed consent.
- Subjects must have tumor(s) invading bone and requiring surgical excision including but not limited to craniomaxillofacial, spine, long bone, and pelvis.
- Subjects must be willing to have quality cross-sectional imaging that will allow for use to develop a 3D printed model.
Key exclusion criteria (8 listed)
- Pregnant or nursing women.
- Subjects that have a serious systemic pathology.
- Subjects that have clotting disorders.
- Subjects that have uncontrolled hypertension.
- Subjects that are HIV-positive.
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 |
|---|---|---|
| 3D Printed Anatomic ModelPatient-specific 3D printed anatomic model for pre-surgical planning | Device | 3D Printed Anatomic Model |
| CT/MRIStandard imaging type for bony tumors | Diagnostic test | 3D Printed Anatomic Model, Standard Imaging |
Primary outcome
Operative time
Time frame: Incision to closure
Operative time of surgical procedure based on incision and closure time
3 secondary outcomes
Blood loss
Time frame: Incision to closure
Adverse Events
Time frame: Surgery to 90 days post-surgery
Tumor margin status
Time frame: Post-surgery (+3 days)
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 6 Feb 2026.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Printed Anatomic Model and CT/MRI in people with Sarcoma, Ewing and Chondrosarcoma, run by Ricoh USA, Inc. at 3 sites in United States.
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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 Alexandra Gormley, PhD (484-501-0588, alexandra.gormley@ricoh-usa.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: Incision to closure). 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 6 Feb 2026.