Using 3D printed models for planning bone tumor surgeries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multi-center, randomized controlled study evaluates the effectiveness of 3D printed models in preoperative planning for the surgical excision of bony tumors. The study will involve up to 150 participants who will be randomly assigned to either use 3D printed models alongside imaging or rely solely on imaging for surgical planning. The primary goal is to assess the impact on operative time, while secondary outcomes include blood loss, postoperative complications, and tumor margin status. The study is expected to last approximately 12 months across three medical centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects must be at least 13 years of age.
2. Subjects must have the ability to provide written informed consent.
3. Subjects must have tumor(s) invading bone and requiring surgical excision including but not limited to craniomaxillofacial, spine, long bone, and pelvis.
4. Subjects must be willing to have quality cross-sectional imaging that will allow for use to develop a 3D printed model.

Exclusion Criteria:

1. Pregnant or nursing women.
2. Subjects that have a serious systemic pathology.
3. Subjects that have clotting disorders.
4. Subjects that have uncontrolled hypertension.
5. Subjects that are HIV-positive.
6. 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.
7. Subject anatomy has changed substantially since the date medical imaging from which the model is derived was obtained (as applicable).
8. Subject is a poor surgical or poor study candidate which may include, any medical, social or psychological problem that could complicate the procedure.

Where it's running

• Kaiser Permanente Oakland Medical Center
  Oakland, California, United States Recruiting
• William Beaumont University Hospital
  Royal Oak, Michigan, United States Recruiting
• The Ohio State University Wexner Medical Center
  Columbus, Ohio, United States Recruiting

Study contacts

• Study coordinator: Alexandra Gormley, PhD
• Email: alexandra.gormley@ricoh-usa.com
• Phone: 484-501-0588

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Testing a new drug combination for treating relapsed or refractory sarcomas in adolescents and young adults

  This study is testing a new combination of drugs to see if it can help adolescents and young adults with tough-to-treat sarcomas feel better and improve their chances of recovery.

  Recruiting Phase 1/2 Dana-Farber Cancer Institute · Boston, Massachusetts and 2 other locations · NCT06709495

• Imaging study using two antibody fragments in patients with solid tumors

  This study is testing two special antibody fragments in people with solid tumors to see how well they target cancer cells and how they move through the body.

  Recruiting Early Phase 1 Var2 Pharmaceuticals · Groningen, Provincie Groningen · NCT06645808

• Comparing single vs double beam proton therapy for certain tumors

  This study is testing whether using one beam of proton therapy is just as effective and safer than using two beams for patients with certain types of tumors.

  Recruiting Centre Antoine Lacassagne · Nice · NCT06029218

• Personalized home exercise program for patients with bone tumors after surgery

  This study tests whether a personalized home exercise program helps patients with bone tumors recover better after surgery and chemotherapy.

  Recruiting Istituto Ortopedico Rizzoli · Bologna · NCT05779670

• Using Regorafenib to Maintain Treatment Benefits After Initial Therapy for Bone Sarcomas

  This study is testing if the drug regorafenib can help people with bone sarcomas stay cancer-free longer after their initial treatment.

  Recruiting at 12 sites Centre Leon Berard · Besançon and 15 other locations · NCT04055220

• Using Abemaciclib to treat certain bone and soft tissue sarcomas with specific genetic alterations

  This study is testing if the drug Abemaciclib can help people with certain types of bone and soft tissue sarcomas that have specific genetic changes.

  Recruiting at 4 sites Phase 2 Medical College of Wisconsin · Jacksonville, Florida and 3 other locations · NCT04040205

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.