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All patients undergoing thermal ablation and cementoplasty procedure for one or more painful bone lesion

Percutaneous thermal ablation with subsequent cementoplasty in a single procedure

Ablation and Cementoplasty

Jason K Wong

Stefan Przybojewski

Stefan Przybojewski, MD

The aim of this research study is to assess the effectiveness of combined ablation and cementoplasty in the treatment of spinal, pelvic, and extraspinal lesions causing pain resistant to conventional treatment at our centre. In particular, the investigator seek to verify the safety and efficacy for multiple primary tumor types and benign lesions as well as encompass multiple measurements of outcome, including visual analog scale (VAS) for pain, opioid and analgesic use, and overall performance scales, combined with cross-sectional imaging follow-up to assess tumor burden, to ascertain a comprehensive Canadian single-centre experience that has been lacking in previous studies.

Research Question \& Objectives

1. To conduct a prospective, single-centre study of combined ablation and cementoplasty treatment for painful spinal and extraspinal osseous lesions.
2. Report the technical outcome and safety of percutaneous ablation prior to image-guided cementoplasty in a single treatment session.
3. Review the effectiveness and durability of pain control, local tumor control, and the impact on QoL using ablation and cementoplasty in treating spinal/extraspinal osseous tumors.
4. Assess the feasibility and efficacy of ablation and cementoplasty treatment for different primary tumor types and benign lesions.

Research Design

The investigators will conduct a single-centre, single-arm, cohort analysis of all patients who undergo cementoplasty for osseous disease in the department of interventional radiology over a two-year period. This will be a prospective paired comparison study with patients serving as their own controls. Technical success and procedural complications will be monitored and recorded for all patients. All patients will be followed until death or 3 months post-procedure.

The investigators aim to enroll a minimum of 40 patients referred for symptomatic osseous lesions. Bipolar radiofrequency ablation (Osteocool RFA system, Medtronic) or cryoablation (Visual Ice Cryoablation, Boston Scientific) will be performed under CT, ultrasound, or fluoroscopic guidance at the discretion of the treating radiologist, and immediately followed by cement injection. Radiological outcomes, including local tumor control and disease progression, will be assessed by CT imaging immediately post-procedure as well as 3-month follow-up. Clinical outcomes will be evaluated by VAS, analgesic use, and QoL assessment using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) prior to procedure and immediately post-procedure, as well at 1-week, 1-month, and 3-month intervals post-procedure.

Single-arm prospective study of pain and quality of life before and after ablation/cementoplasty procedure

Ablation and Cementoplasty for Painful Bone Lesions

Percutaneous Ablation and Cementoplasty for Painful Bone Lesions: A Canadian Single-Centre Experience

Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). The QLQ-C30 is composed of 3 multi-item scales including a functional scale, a global health status/quality of life scale, and a symptom scale. Each scale ranges in score from 0-100 with a higher scale score representing a high/healthy level of functioning, quality of life, and symptomatology/problems, respectively.

Tumor burden as assessed by CT scan following procedure as compared to pre-procedure scan

University of Calgary

Interventional Radiologist; Clinical Associate Professor, University of Calgary

All Drugs and Chemicals

Tin Fluorides

A single arm with patients with advanced cancer who have all of the following:

1. refractory pain and/or gait disturbance caused by pelvic bone metastasis, did not respond to conservative treatment.
2. osteolytic lesion (in predominance) suitable for the pain.
3. limited life expectancy (less than 3 years) or stopping medical treatment.

Exclusion criteria:

There are no absolute contraindications for the procedure; however, the relative contraindications are:

1. patients in poor condition with an expected survival period of less than 3 months.
2. patients with stable course, with long life expectancy (more than 3 years) or those considered candidates for major pelvic surgery including tumor removal and hip arthroplasty.
3. presence of bone destruction with soft tissue mass contaminating important organs, nerves and blood vessels (improvement is not expected).
4. Patients refusing to give a written consent to the study protocol.

Percutaneous image guided cementoplasty will be performed as follows:

Low-viscosity radiopaque bone cement will be quickly mixed and transferred to 1-ml syringes to reduce injection resistance. Injection will be initiated 2-4 min after mixing. When the resistance to cement injection becomes high in the beginning, the cement will be pushed in with a stylet, and it will go well afterward. As much bone cement as possible will be injected while avoiding leakage into the hip joint, sciatic notch, or veins under fluoroscopic monitoring. When significant cement leakage occurred at the initial stage, cement injection will be performed via another route or will be stopped and resumed when the cement viscosity increased. The cement will begin to harden after 8 min, and the operator, therefore, will aim to complete the delivery of the injection within 10 min. The injection needles must be removed before the cement hardens completely

Percutaneous cementoplasty

This study aimed to summarize the immediate operative and short-term efficacy and safety outcomes of percutaneous cementoplasty for pelvic metastases

Bone metastasis (BM) is the major cause of morbidity in patients with cancer. After lungs and liver, bone is the third most common site of metastatic disease. Prostate and breast cancers are responsible for the majority of bone metastases (up to 70%), followed by thyroid, lung, urinary bladder, and renal cancers, and finally melanoma. The incidence of bone metastasis is approximately 100,000 new cases per year in the united states and is increasing. Bone metastasis could result in skeletal-related events, including pain, pathological fracture, hypercalcemia, and nerve and visceral compression, which seriously affect the quality of life (QoL) of cancer patients. Bone metastases can be classified as osteolytic (osteoclast-mediated bone resorption), osteoblastic (osteoblast-mediated bone deposition), or mixed.

Fifty percent of the pain symptoms experienced by patients with cancer originate from BM. Tumor extension to neural structures, can cause a pain that may be radicular (exacerbated by percussion or palpation) and/or mechanical (exacerbated by movement). In advanced cases, pain can become intolerable and refractory to conventional therapies, resulting in walking disability, psychological and functional impact, and significant worsening of the QoL.

The effectiveness of surgery for bone metastasis in advanced cancer patients is limited to improvement of patients' quality of life. In most of these patients, complete resection or extended curettage of the bone metastasis with major reconstruction is often not feasible due to their poor general condition and accompanying other metastases. For some types of these bone metastases, surgical resection can lead to the stripping of the surrounding soft tissue and muscle attachment and addressing bone defects, causing more intraoperative bleeding, prolonged healing time, and increase the risk of wound complications, which in turn result in a longer recovery time for patients who usually have a limited life expectancy. Therefore, less invasive procedures, including percutaneous ablation (microwave ablation, radiofrequency ablation, cryoablation, and high-energy ultrasound) and/or bone cement \[polymethylmethacrylate (PMMA)\] injection, have become possible options. This is especially true for pelvic metastatic lesions because the surgery is particularly burdensome.

In addition, life expectancy of patients with metastatic bone disease is the most important factor in the decision making for surgical and/or medical treatment. A short life expectancy is in favor of the use of less invasive procedures, that have lower complication rates and shorter rehabilitation times. In these situations, interventional radiology procedures play an important either primary or complementary role in the management of bone metastases, especially in terms of palliation of pain, improvement of ambulation problems and treatment of fractures. This is because short life expectancies, more often, require palliative rather than curative regimens and make rapid pain relief to become a priority.

Aim of the study This study aimed to summarize the immediate operative and short-term efficacy and safety outcomes of percutaneous cementoplasty for pelvic metastases.

Materials and methods

Target Patients:

The study will include 20 patients with advanced cancer fulfilling the inclusion criteria and giving an informed consent to the study protocol (a single arm).

The following data will be collected from all patients:

1. Age at the time of the procedure
2. Gender
3. Primary cancer
4. Presence of lung metastasis
5. Presence of peritoneal metastasis
6. From the total bone scan:

   1. Unilateral or bilateral pelvic bone metastasis
   2. Solitary or oligometastasis (less than three sites) or multimetastasis ( 3 sites or more).
   3. Presence or absence of spine metastasis
   4. Presence or absence of lower limb metastasis
7. Previous surgery for cancer (site of the operation; pelviabdominal, lower limbs, spine, chest, brain)
8. Chemotherapy (preoperative, postoperative or both)
9. Radiotherapy (preoperative, postoperative or both)

Procedure:

The procedure will be performed under either spinal or general anesthesia. The patient will be placed in the lateral decubitus position with the surgical side up. The needle entry point will be adjusted with a fluoroscopic guide near the point 10 cm posterior to the anterior superior iliac spine. The skin and bone will be punctured by a 11-gauge needle. At least 2 or 3 different routes to the lesion will be established, and one needle will remain empty to allow decompression if possible.

The detailed procedure is described in the intervention section below. During the injection of PMMA, the anesthesiologist carefully will monitor the change in blood pressure and pulse rate, given the known toxicity of bone cement. The injected dose will vary according to the number of metastatic sites injected and their sizes.

All patients who has no contraindication to anticoagulation will be given (enoxaparin 40-60 mg per day) from 1 day before the procedure until ambulation was resumed for deep vein thrombosis prophylaxis.

The following procedural data will be collected:

1. Total cement amount
2. Injection needle number
3. Injection site number
4. Injected sites (Iliac bone or crest, acetabulum, ischium, pubic)
5. Duration of the procedure (in minutes)
6. Type of anesthesia used
7. If any other operation is performed concomitantly (nominate).

Outcome measures:

Primary outcome: is pain reduction:

Secondary outcomes: are

I- Gait function:

1. Gait status will be recorded pre and post operative
2. Gate function change II- Complications of the procedure (if more than one complication occurred in the same patient, all complications will be recorded)

A. Local:

1- Extraosseous bone leakage 2- Pathological fracture of the pelvic bones B. Systemic

1. Mortality
2. Pulmonary embolism
3. Bone cement implantation syndrome (BCIS):

Follow-up outcomes: at one month and 3 months

1. Mortality
2. Pain relapse (NRS score)
3. Gait relapse
4. Pathological fracture in the pelvic bones at the treated sites (by bone window CT).

Imaging Guided Cementoplasty for Pelvic Bone Metastasis

Immediate and Short-term Outcomes of Imaging Guided Percutaneous Cementoplasty for Pelvic Bone Metastases

To evaluate pain, the numerical pain score (NRS) will be used. The NRS is an 11-point numerical scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain (Figure 3) and pain is classified as mild pain if 1-4 points (tolerable), moderate if 5-6 points and severe if 7-10 points. NRS has been shown to be particularly reliable especially among patients with low health literacy. The NRS is also simple to score, and can be administered both orally and in written form.

Gait status will be recorded pre and post operative: with the following order from better to worse i. Normal ii. Limping iii. Independent with crutch or cane iv. Wheelchair v. Bed-ridden vi. Dead

It is a safety local outcome that reports extraosseous cement leakage (intra-articular "nominate joint", elsewhere)

A safety local outcome that is reported by history and confirmed by CT that could be impending or displaced

procedure related mortality is considered within 2 weeks of the procedure

(Pulmonary embolism caused by thrombus, fat, tumor emboli, or bone cement will be diagnosed by pulmonary CT with contrast if clinically suspected). For pulmonary embolism, clinical or radiological factors that might be related to its occurrence were collected, including primary cancer type, presence of lung metastasis, injected cement amount and number, local cement leakage during the procedure, pathologic fracture at the site for procedure, and injected route number.

1- defined as hypoxia, hypertension or both, and/or unexpected loss of consciousness occurring around the time of cementation. BCIS will be classified according to severity of symptoms:

1. grade 1 was moderate hypoxia (SpO2 \< 94%) or hypotension (fall in SBP \> 20%)
2. grade 2 was severe hypoxia (sPO2\<88%) or hypotension (fall in SBP\>40%) or unexpected loss of consciousness
3. grade 3 was cardiovascular collapse requiring cardiopulmonary resuscitation (CPR).

Assiut University

Resident Radiology

Analgesics

Patient with percutaneous osteosynthesis and cementoplasty procedure will be included.

Patients have assessed for pain and quality of life during consultations as part of an interventional radiology procedure (pre-procedure consultation, and follow-up consultations at 1, 3, 6 and 12 months after the procedure.

The evaluation of the quality of life was conducted with the EQ5D (EuroQol 5 Dimensions) score (min 0: bad health and max:100 good health).

EQ5D (EuroQol 5 Dimensions)

the type and intensity of pain will be evaluated by Numerical Rating Scale (NRS) from 0 to 10 in different positions and in different activities (e.g. background pain, general maximum/minimum pain, pain of the site treated by the procedure, pain at rest, in lying position, in sitting position, in standing position, at bearing weight, in walking, description of painful irradiations, nocturnal awakenings).

Numerical Rating Scale (NRS)

the consumption of analgesics by step and by dosage will be evaluated.

evaluated the consumption of analgesics

Sylvain GRANGE, MD

Sylvain BERTHOLON, resident

In oncology, therapeutic progress has allowed a significant increase in life-expectancy: a growing number of cancer survivors live to more advanced metastatic stages. Consequently, the prevalence of secondary bone lesions is increasing, which are frequent and disabling. They are responsible for pain and a high risk of pathological fractures. The average prevalence of pain in cancer represents 53% for all stages combined and 64% for metastatic stages.

Analgesics, radiotherapy and surgery are widely used in this context, but are not without side effects.

Cementoplasty is an interventional radiology procedure that has improved the palliative management of bone lesions. It consists of a percutaneous injection of polymethylmethacrylate-based cement, whose physical and chemical properties provide resistance to compressive stress during weight-bearing activities. However, one of the main disadvantages of cement is its low resistance to torsional stress, as evidenced notably in vitro tests. Thus, cementoplasty alone is very effective at the spinal level (compressive forces) to reduce pain and risk of fracture, but much less effective at the level of other bones that are subjected to torsional stresses, notably the pelvis and femur (40% fracture rate at one year after cementoplasty alone of femoral metastasis).

Fixation using a combination of metal screws and cement provides resistance to torsional and compressive stress. In addition, it has been shown that there is a significant risk of secondary screw displacement if screws are not combined with cement in secondary bone lesions. Combination of percutaneous screw fixation and cementoplasty is a mini-invasive procedure which allows limiting complications and the duration of treatment: early standing up, almost no blood loss, reduced risk of venous thromboembolism (VTE), rapid healing.

The aim of this prospective study is to evaluate feasibility, safety, and efficacy of combination of percutaneous screw fixation and cementoplasty for lytic bone metastases.

Combination of Percutaneous Screw Fixation and Cementoplasty for Lytic Bone Metastases

Combination of Percutaneous Screw Fixation and Cementoplasty for Lytic Bone Metastases: Feasibility, Safety and Early Clinical Outcomes. Monocentric Study

The technical success of the procedure is defined as (all criteria have to be fulfilled) :

* the correct placement of the screw(s),
* any complication as major cement leakage such as intra-articular or intra-vascular leakage, abundant bleeding, vascular or nervous lesion, displacement of bone fragment

Theses criteria are measured on CT-scan

To confirm the safety of the procedure, all adverse events related to the procedure are screened and reported

Numerical Rating Scale (NRS) evaluates the pain. This scale starts from 0 (no pain) to 10 (maximal pain)

EQ5D evaluates the quality of life.. Patients are asked to describe their own health and also provide a self-rating on a 20-cm vertical scale with endpoints of 'best imaginable health state' set at 100 and 'worst imaginable health state' set at 0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ablation and Cementoplasty for Painful Bone Lesions	NCT04635137	Bone Lesion Bone Metastases Spine Metastase...	Ablation and Ce...	18 Years -	University of Calgary
Imaging Guided Cementoplasty for Pelvic Bone Metastasis	NCT06231628	Imaging Guided Percutaneous Ce... Pelvic Bone Met...	Percutaneous ce...	-	Assiut University
Imaging Guided Cementoplasty for Pelvic Bone Metastasis	NCT06231628	Imaging Guided Percutaneous Ce... Pelvic Bone Met...	Percutaneous ce...	-	Assiut University
Combination of Percutaneous Screw Fixation and Cementoplasty for Lytic Bone Metastases	NCT05191264	Interventional ...	EQ5D (EuroQol 5... Numerical Ratin... evaluated the c...	18 Years -	Centre Hospitalier Universitaire de Saint Etienne

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