White Paper 3

Elevating Stereotactic Body Radiation Therapy with Carbon/PEEK Implants: A Game Changer in Postoperative Radiation Oncology 

This white paper concisely highlights the importance of improved postoperative SBRT for patients with spinal metastases.

Precision with Care: BlackArmor® Carbon/PEEK Optimizes Radiation Therapy for Improved Outcomes
in Spinal Oncology 

The field of spinal oncology is at the forefront of a ground-breaking transformation. This white paper explores the compelling benefits of BlackArmor® Carbon/PEEK implants in conjunction with postoperative radiation therapy. By examining the current landscape of spinal oncology, the challenges it faces, and the immense potential of Carbon/PEEK technology, we aim to shed light on the future of precise, safe, and patient-centric care.

Stereotactic Body Radiation Therapy (SBRT) has emerged as a pivotal tool in the management of spinal oncology cases. SBRT delivers high doses of radiation to small tumor volumes, such as residual tumor cells, reducing the risk of tumor recurrence and improving long-term disease control.1Cao, Y., et al., The impact of local control on widespread progression and survival in oligometastasis-directed SBRT: results from a large international database. Radiother Oncol, 2023: p. 109769.

A randomized international phase II study has demonstrated a 22-month improvement in median overall survival (OS) with SBRT for oligometastatic cancer patients compared to patients who received a standard care such as conventional External Beam Radiation Therapy (cEBRT), with a 25% survival benefit at 5 years.2Palma, D.A., et al., Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastatic Cancers: Long-Term Results of the SABR-COMET Phase II Randomized Trial. J Clin Oncol, 2020. 38(25): p. 2830-2838. 

“Having the confidence of delivering the prescribed dose allows us to minimize the safety margins and plan higher dose to the tumor.”
Dr. Steve Braunstein
Radiation Oncologist

Often used metal implants, such as titanium, interfere with imaging and radiation beams, thus limiting the administration of radiation therapy across multiple steps.   

The artifacts created by metal implants obscure critical areas such as the spinal cord and epidural space and lead to uncertainties in radiation planning and administration.3Muller, B.S., et al., The dosimetric impact of stabilizing spinal implants in radiotherapy treatment planning with protons and photons: standard titanium alloy vs. radiolucent carbon-fiber-reinforced PEEK systems. J Appl Clin Med Phys, 2020. 

Challenges in delineating the tumor volume and organs at risk are compounded by uncertainties in dose calculations resulting from erroneous information caused by imaging artifacts. The dose coverage region in the epidural space, between the spinal cord and the vertebral body, is at high risk of tumor recurrence after treatment, even without instrumentation.4Chan, M.W., et al., Patterns of epidural progression following postoperative spine stereotactic body radiotherapy: implications for clinical target volume delineation. J Neurosurg Spine, 2016. 24(4): p. 652-9.

The uncertainties associated with metal hardware lead to larger safety margins around the spinal cord and target volume. 

T2-weighted MRI showing the radiation plans for a patient with CFRP (A) and titanium (B) (1)
Axial MRIs showing the radiation plans for a patient with Carbon/PEEK (A) and titanium (B) screws, respectively.
Structure identification on postoperative MRI is facilitated by reduced artifacts with BlackArmor® Carbon/PEEK.
Taken from Almeida et al., 2023.

Radiolucent implants significantly improve imaging quality, enabling radiation oncologists to achieve a more precise delineation of the spinal cord, critical organs at risk, and the tumor volume. This precise delineation is crucial as it allows for the delivery of the maximum safe dose to the tumor, enhancing the likelihood of successful treatment, while minimizing the risk of toxicity to surrounding organs at risk. Such advancements in visualization and tumor delineation are especially beneficial in treating patients with complex tumors or those with radioresistant histology, as it enables dose-escalated treatments. These treatments aim to increase the probability of long-term local control of the tumor, thus potentially improving patient outcomes.   

For physicians, the integration of BlackArmor® Carbon/PEEK implants in the management of spinal oncology marks a paradigm shift in treatment, promising enhanced therapeutic precision and superior patient-centric care.

Radiooncology

NOTE: Not all icotec implants have been evaluated for safety in the MR environment.
Some have not been tested for heating or unwanted movement in the MR environment.
The safety of these implants in the MR environment is unknown. Performing an MR exam on
a person who has such a medical device may result in injury. Please consult the respective instructions for use regarding information on the safety and compatibility of the individual icotec implants in the MR environment.