3D Printed Models for Bone Cancer

Recruiting at1 trial location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Ricoh USA, Inc.

Disqualifiers: Pregnancy, Clotting disorders, HIV, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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 3 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.

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 data supports the effectiveness of the treatment 3D Printed Models for Bone Cancer?

Research shows that 3D printed models help in surgical planning by providing detailed views of tumors and surrounding structures, which can lead to shorter surgeries and less blood loss. They also improve patient satisfaction and functional outcomes when used for custom prosthetic reconstructions in bone cancer surgeries. ^{1 2 3 4 5}

Is using 3D printed models for bone cancer surgery safe?

Research shows that using 3D printed models in bone cancer surgeries is generally safe, with most patients not experiencing complications during or after surgery. The technology helps in surgical planning and has been associated with satisfactory outcomes and reduced complication rates. ^{1 3 4 5 6}

How is the 3D Printed Anatomic Model treatment different from other treatments for bone cancer?

The 3D Printed Anatomic Model treatment is unique because it uses 3D printing technology to create personalized models of a patient's bone structure and tumor, which helps surgeons plan and perform surgeries more accurately and safely, reducing operative time and blood loss. ^{1 4 7 8 9}

Research Team

Eligibility Criteria

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)

Trial Timeline

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

Treatment Details

Interventions

• 3D Printed Anatomic Model (Procedure)

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.

Participant Groups

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 China for the following indications:

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Using 3D models in orthopedic oncology: presenting personalized advantages in surgical planning and intraoperative outcomes. [2020]

2. United States 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. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Three-Dimension-Printed Custom-Made Prosthetic Reconstructions in Bone Tumors: A Single Center Experience. [2023]

4. Netherlands 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. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

From 3-Dimensional Printing to 5-Dimensional Printing: Enhancing Thoracic Surgical Planning and Resection of Complex Tumors. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Current Concepts and Advances of Three-Dimensional Printing in Reconstructive Musculoskeletal Oncology: A Systematic Review. [2022]

7. England pubmed.ncbi.nlm.nih.gov

3D printed composite model of pelvic osteochondroma and nerve roots. [2023]

8. Japan pubmed.ncbi.nlm.nih.gov

The application of 3D-printing technology in pelvic bone tumor surgery. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Implementation of the three-dimensional printing technology in treatment of bone tumours: a case series. [2022]