3D Printed Models for Bone Cancer

Recruiting at 1 trial location

Overseen By Alexandra Gormley, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ricoh USA, Inc.

Disqualifiers: Pregnancy, Clotting disorders, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether 3D printed models can make surgeries to remove bone cancer more efficient. The study compares two groups: one uses 3D printed models (also known as 3D Printed Anatomic Models) along with imaging scans like CT or MRI, while the other uses only imaging scans. The main goal is to determine if these models reduce surgery time. Researchers also aim to find out if they decrease blood loss and improve surgical accuracy. Suitable participants have tumors affecting their bones, such as in the face, spine, or pelvis, and require surgery for removal. As an unphased trial, this study offers a unique opportunity to contribute to innovative surgical techniques that could enhance future patient care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that 3D printed models are safe for preoperative planning?

Research has shown that using 3D printed models in surgeries is generally safe and well-accepted. These models help surgeons plan more effectively by clearly displaying the shape of tumors, nearby bones, and blood vessels. This planning can make surgeries faster and more accurate.

No specific reports have indicated harmful effects on patients from using 3D printed models. The primary goal is to improve surgical outcomes rather than address direct safety issues. While there is no direct safety concern, using these models aims to make surgeries smoother and potentially reduce complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using 3D printed anatomic models for bone cancer surgery because they offer a personalized and precise approach to tumor removal. Unlike standard imaging techniques alone, these models provide a tangible representation of a patient's anatomy, allowing surgeons to plan and practice complex procedures with greater accuracy. This innovative method has the potential to enhance surgical outcomes by improving precision, reducing operation times, and potentially preserving more healthy tissue.

What evidence suggests that 3D printed models are effective for bone cancer surgery?

Research has shown that using 3D printed models in surgery can greatly improve pre-operative planning. In this trial, participants in one arm will have tumors excised with prior planning that utilizes 3D printed models and imaging (CT or MRI). These models provide a clear view of the tumor and surrounding areas, which is especially important in bone surgeries. One study found that using 3D printed models with imaging can lead to better planning and possibly fewer complications during surgery. These models also enhance surgical precision by matching the unique shape of each patient's body. Overall, early evidence suggests that 3D printed models could lead to better surgical outcomes, such as shorter surgery times and less blood loss. Participants in the other arm will undergo tumor excision with prior planning that uses only imaging (CT or MRI) without a 3D printed model. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with certain bone-related tumors, including Fibrous Histiocytoma and Osteosarcoma. Participants should be suitable candidates for surgery to remove their tumor. The study excludes specific details on who can't join.

Inclusion Criteria

Subjects must have the ability to provide written informed consent

Subjects must be willing to have quality cross-sectional imaging that will allow for use to develop a 3D printed model

My cancer has spread to my bones and needs surgery.

Exclusion Criteria

Pregnant or nursing women

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Planning

Participants undergo pre-operative planning using either 3D printed models and imaging or standard imaging

4-6 weeks

Surgery

Participants undergo tumor excision surgery

1 day

Follow-up

Participants are monitored for safety and effectiveness, including adverse events and tumor margin status

90 days

1 visit (in-person) at 90 days post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• 3D Printed Anatomic Model

Trial Overview The study compares the use of 3D printed models plus imaging versus imaging alone (like CT/MRI scans) in planning surgeries to remove bone tumors. It aims to see if 3D models can shorten surgery time and improve other outcomes like blood loss and surgical satisfaction.

How Is the Trial Designed?

Group I: 3D Printed Anatomic Model Experimental Treatment 2 Interventions

Participants in this arm will have tumors excised with prior planning utilizing 3D printed models and Imaging (CT or MRI).

Group II: Standard Imaging Active Control 1 Intervention

Participants 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 is already approved in European Union, United States, China for the following indications:

Approved in European Union as 3D Printed Anatomic Model for:

• Preoperative planning for tumor excision
• Surgical training and education

Approved in United States as 3D Printed Surgical Model for:

• Preoperative planning for complex surgeries
• Orthopedic and oncologic surgical procedures

Approved in China as Custom 3D Printed Model for:

• Bone tumor surgery
• Reconstruction of bone defects

Who Is Running the Clinical Trial?

Ricoh USA, Inc.

Lead Sponsor

Trials

1

Recruited

150+

Published Research Related to This Trial

This study involved 9 patients with complex primary spine tumors, where 3D-printed models were created from their imaging data to assist in preoperative planning and intraoperative guidance.

The use of these patient-specific 3D models was found to be technically useful during surgery, enhancing the surgical team's ability to navigate and plan for the unique anatomy of each tumor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-Dimensional Printed Anatomic Modeling for Surgical Planning and Real-Time Operative Guidance in Complex Primary Spinal Column Tumors: Single-Center Experience and Case Series. Leary, OP., Crozier, J., Liu, DD., et al.[2021]

A case study of a male in his early 30s with recurrent osteosarcoma of the left maxilla demonstrated that 3D printing technology can significantly enhance surgical planning and patient understanding by providing personalized models of the tumor.

Osteosarcoma in the head and neck is a rare and aggressive cancer, typically presenting with destructive growth in the mandible or maxilla, and 3D printed models can aid in the diagnostic process and surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3D print model for surgical planning in a case of recurrent osteoblastic osteosarcoma of the left maxilla. A case report. Zapata-Julían, P., Avendano, D., Diaz-Peréz, HM., et al.[2023]

In a study of 11 patients, mostly children with bone tumors, the use of custom-made 3D-printed prostheses significantly aided in reconstructing bone defects after tumor resection, improving both cosmetic outcomes and quality of life.

Despite a complication rate of 54%, including implant dislocations and limited range of motion, the 3D-printed implants facilitated clear surgical resections and functional recovery, highlighting their potential in orthopedic oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of the three-dimensional printing technology in treatment of bone tumours: a case series. Jovičić, MŠ., Vuletić, F., Ribičić, T., et al.[2022]

The development of 5-dimensional (5D) printing enhances surgical planning by integrating multiple imaging modalities, including pre- and post-treatment scans, which allows for a more comprehensive understanding of complex thoracic tumors.

Using 5D models improves the surgical team's ability to plan operations, select resection margins, and anticipate challenges, ultimately benefiting both surgical education and patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From 3-Dimensional Printing to 5-Dimensional Printing: Enhancing Thoracic Surgical Planning and Resection of Complex Tumors. Gillaspie, EA., Matsumoto, JS., Morris, NE., et al.[2023]

The study evaluated 3D-printed custom-made prostheses in 8 patients undergoing major oncological bone resection, showing a high mean satisfaction rate of 7.38 out of 10 one year post-surgery.

Despite no significant changes in functional outcomes (KPS, ADL, IADL scores), the use of custom prostheses effectively reconstructed complex bone defects, suggesting they are a viable option for limb salvage in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-Dimension-Printed Custom-Made Prosthetic Reconstructions in Bone Tumors: A Single Center Experience. Vitiello, R., Matrangolo, MR., El Motassime, A., et al.[2023]

In a study involving 12 patients, 3D-printing technology was successfully used for pelvic bone tumor surgeries, allowing for precise resection and reconstruction with customized bone-cutting guides and implants.

All patients achieved independent gait recovery post-surgery, demonstrating the potential efficacy and safety of 3D-printed solutions in complex pelvic surgeries, although one patient experienced local recurrence leading to amputation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of 3D-printing technology in pelvic bone tumor surgery. Park, JW., Kang, HG., Kim, JH., et al.[2022]

A 3D-printed composite model of the lower lumbar spine, pelvis, and nerve roots was successfully created for a patient with a pelvic tumor, enhancing preoperative planning and surgical precision.

The use of this model allowed for a complete tumor resection without neurological complications, demonstrating the efficacy and safety of 3D printing in complex orthopedic surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3D printed composite model of pelvic osteochondroma and nerve roots. Fox, O., Kanawati, A.[2023]

3D printed models significantly enhance pre-operative planning for complex orthopedic surgeries by accurately representing tumor geometry and surrounding anatomy, leading to reduced operative time and blood loss.

In a study involving four complicated cases, these models helped orthopedic surgeons create personalized surgical plans, ultimately improving the selection of prosthetic devices and surgical approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using 3D models in orthopedic oncology: presenting personalized advantages in surgical planning and intraoperative outcomes. Punyaratabandhu, T., Liacouras, PC., Pairojboriboon, S.[2020]

Three-dimensional printing technology has been shown to be safe and effective in the surgical management of musculoskeletal tumors, with 72.8% of patients experiencing no complications and 97.3% achieving satisfactory functional and oncological outcomes after surgery.

The use of this technology can reduce operative time and complication rates, making it a cost-effective and reliable option for orthopedic oncology, as demonstrated in a review of 73 studies involving 449 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Concepts and Advances of Three-Dimensional Printing in Reconstructive Musculoskeletal Oncology: A Systematic Review. Yen, WW., Baksh, N., Gallo, V., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6261090/

Using 3D models in orthopedic oncology Three Dimensional (3D) printed models can aid in effective pre-operative planning by defining the geometry of tumor mass, bone loss, and nearby vessels.

2. stratasys.com stratasys.com/contentassets/e2d4e8bcd3fc49df8845703bac260dc0/eb_pj_clinical-efficacy_a4_0523a.pdf?v=49a4c2

Clinical Efficacy and Outcomes The study: 3D printed drill guides were designed specific to each surgical plan, with one side shaped to fit the patient's bone and the other side containing ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2213398420300890

3D printing applications for the treatment of cancer 3D printing technology has a unique capability to manufacture tumour models. It helps to understand the status of the whole tumor.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7909290/

Computer Navigation and 3D Printing in the Surgical ... The long-term outcomes of osteosarcoma have improved; however, patients with metastases, recurrence or axial disease continue to have a poor ...

5. threedmedprint.biomedcentral.com threedmedprint.biomedcentral.com/articles/10.1186/s41205-024-00210-5

Quality assurance of 3D-printed patient specific ... This review focuses on literature on quality assurance of patient-specific anatomical models in terms of geometric accuracy published before December 4th, 2022.

6. threedmedprint.biomedcentral.com threedmedprint.biomedcentral.com/articles/10.1186/s41205-018-0035-6

Using 3D models in orthopedic oncology: presenting ... Three Dimensional (3D) printed models can aid in effective pre-operative planning by defining the geometry of tumor mass, bone loss, and nearby vessels.

7. stratasys.com stratasys.com/en/resources/blog/how-3d-printed-anatomical-models-improve-surgical-planning/

3D-Printed Anatomical Models: Evidence for Surgical ... See how 3D-printed anatomical models improve surgical planning, cut OR time and cost, and strengthen team communication—backed by recent ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9561186/

Application of 3-dimensional printing implants for bone tumors Clinical outcomes and complications after limb salvage surgery using custom-made 3D-printed implants have been reported in a few studies owing to the novelty of ...

9. explorationpub.com explorationpub.com/Journals/emd/Article/100794

Quality approaches and standards of 3D printing in ... This systematic review consolidates current knowledge on quality standards and implementation strategies for 3D printing in orthopedic and traumatological care.