Functional Assessment + X-Ray Imaging for Pelvic Sarcoma

Overseen By Valerae O Lewis, BS,MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: External hemipelvectomy, Hip surgery, Pregnancy, Pacemaker, others

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

Compensation: Varies

Number of Visits: 2

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on improving surgery outcomes for individuals with pelvic sarcomas, a type of cancer in the pelvic bone. By using personalized computer models to simulate walking, doctors aim to plan better surgeries and rehabilitation, helping patients walk more comfortably after treatment. Participants will either have their walking assessed with motion capture and X-rays (X-Ray Imaging) or provide past medical imaging and therapy records. Suitable candidates for this trial include those who have had or will have a specific pelvic surgery at UT MD Anderson Cancer Center. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance surgical outcomes and rehabilitation for future patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these methods are safe for improving surgical planning and rehabilitation in pelvic sarcoma patients?

Research shows that the treatments in this trial are generally safe and well-tolerated. Here's a breakdown:

1. **Functional Assessment and Patient-Specific Walking Models**: These non-invasive methods enhance patients' walking ability post-surgery. Studies have shown these models can predict walking ability without causing harm. They function like simulations or virtual tests tailored to each patient.

2. **X-Ray Imaging**: X-rays, commonly used in medicine, allow doctors to see inside the body. Although they involve radiation, the amount is very low. Research on X-ray use for sarcoma (a type of cancer) indicates they are safe when used correctly. The radiation risk is minimal.

Overall, these treatments are safe and designed to help, not harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to assess and understand pelvic sarcoma treatment outcomes. Unlike traditional methods that might rely solely on standard imaging techniques, this trial uses functional assessments combined with advanced technologies like optical motion capture and bi-plane dynamic X-ray imaging. This approach provides a more comprehensive view of how patients recover their walking function before and after surgery. By leveraging patient-specific computational walking models, researchers hope to gain deeper insights into individual recovery patterns, potentially leading to more personalized and effective treatment plans in the future.

What evidence suggests that these methods are effective for improving surgical planning and rehabilitation in pelvic sarcoma patients?

Research has shown that personalized computer models can enhance surgery and recovery for patients with pelvic sarcoma, a type of cancer. These models assist doctors in selecting the best surgical methods to improve walking ability post-surgery. In this trial, participants in the supportive care arm will undergo walking function assessment using optical motion capture and bi-plane dynamic X-ray imaging before and after hemipelvectomy. Tests of movement and X-ray images also clarify how surgery impacts walking and guide personalized recovery plans. Overall, these tools aim to improve recovery and walking outcomes for those undergoing pelvic sarcoma surgery. ^{1 2 6 7 8}

Who Is on the Research Team?

Valerae O. Lewis

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults who have or will undergo internal hemipelvectomy at UT MD Anderson Cancer Center to treat pelvic sarcomas. It's not for those with certain hip conditions, previous significant hip injuries/surgeries, recent surgeries affecting movement, pregnant/nursing women, or individuals with specific metal implants.

Inclusion Criteria

I am scheduled for or have had a surgery to remove part of my pelvis at UT MD Anderson.

Exclusion Criteria

Persons with a pacemaker, hearing aid, aneurysm clips or artificial heart valves, and other forms of loose metal implants will be excluded from the study as assessed by a pre-MRI questionnaire administered by the MRI technician at the time of the scan

I have had surgery or a major injury to my hip.

Pregnant women or women nursing an infant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Assessment

Patients undergo walking function assessment using optical motion capture and bi-plane dynamic X-ray imaging pre-hemipelvectomy

1-2 weeks

1 visit (in-person)

Surgery and Immediate Post-Surgery

Patients receive hemipelvectomy surgery and immediate post-surgery care

1 week

Post-Surgery Assessment

Patients undergo walking function assessment using optical motion capture and bi-plane dynamic X-ray imaging post-hemipelvectomy

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Functional Assessment
• Patient-Specific Computational Walking Models
• X-Ray Imaging

Trial Overview The study is developing personalized computational models to improve surgical planning and rehabilitation for better walking function after surgery in patients with pelvic sarcomas. It involves functional assessments and X-ray imaging to tailor treatment approaches.

How Is the Trial Designed?

Group I: Supportive care (walking function test, X-ray) Experimental Treatment 2 Interventions

Patients undergo walking function assessment using optical motion capture and bi-plane dynamic X-ray imaging pre- and post-hemipelvectomy.

Group II: Retrospective Group Active Control 1 Intervention

1. Acquisition of pre- and post-operative MRI data of the pelvic region (when available) collected previously as part of standard clinical care 2. Acquisition of pre-operative CT data of the pelvic region (when available) collected previously as part of standard clinical care 3. Acquisition of Physical Therapy Assessment data collected previously by a physical therapist and/or physical therapist assistant under protocol PA12-1046

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A new method combining a material testing machine with a 3D video motion capturing system successfully measures the dynamic 3D deformation of pelvic bones, achieving a measurement accuracy of ± 0.036 mm, which is crucial for designing better orthopedic implants.

This innovative setup allows for more realistic datasets that can improve the understanding of material characteristics in anatomical specimens, leading to enhanced biomechanical modeling and potentially more effective implant designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3D video-based deformation measurement of the pelvis bone under dynamic cyclic loading. Göpfert, B., Krol, Z., Freslier, M., et al.[2021]

In a study of 5 patients who underwent surgery for pelvic chondrosarcoma, all patients reported no pain and demonstrated good functional outcomes in work and gait, indicating effective recovery post-surgery.

The study found a significant relationship between hip extension strength and various functional measures, such as gait velocity and weight bearing, suggesting that strengthening hip muscles is crucial for improving mobility after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A follow-up examination of the function of the lower extremity after pelvic tumour extirpation including the acetabular ring. Olsson, E.[2008]

A study involving seven patients who underwent various types of pelvic tumor resections showed that using a hip stabilizer significantly improved their walking speed and other gait parameters, indicating better control over the affected limb.

The findings suggest that a biomechanical approach, such as using a hip stabilizer, can enhance post-operative mobility and gait function in patients after pelvic tumor surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of an external hip joint stabiliser on gait function after surgery for tumours located around the circumference of the pelvis: analysis of seven cases of internal hemipelvectomy or proximal femur resection. Akiyama, T., Saita, K., Ogura, K., et al.[2018]

A systematic review of 18 studies found that surgery for lower extremity sarcoma significantly impacts balance, gait, and physical activity outcomes, but existing measures lack the ability to accurately differentiate between clinical groups like limb-sparing surgery and amputation.

There is a critical need for the development of consistent, valid, and reliable objective measures to assess physical functioning in patients post-surgery for lower extremity sarcoma, as current studies show limitations in reliability and sensitivity to change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Objective clinical measurement of physical functioning after treatment for lower extremity sarcoma - A systematic review. Furtado, S., Errington, L., Godfrey, A., et al.[2022]

This study compared two musculoskeletal models (Human Body Model and OpenSim gait2392) using data from 7 healthy adults, revealing significant differences in joint kinematics, kinetics, and muscle forces, which can impact biomechanical gait analysis outcomes.

The differences in results were attributed to variations in joint center locations and pelvic reference frames, suggesting that while clinical interpretations may remain valid, mechanical analyses requiring precise estimates of movement and loading could be affected by the choice of model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OpenSim Versus Human Body Model: A Comparison Study for the Lower Limbs During Gait. Falisse, A., Van Rossom, S., Gijsbers, J., et al.[2023]

The StepWatch Activity Monitor (SAM) was validated as an effective tool for objectively measuring walking performance in 29 adult patients with lower extremity sarcoma, showing a moderate positive correlation (r = 0.56) with the Toronto Extremity Salvage Score (TESS).

Patients with osseous tumors walked significantly less (average 1882 steps) compared to those with soft tissue sarcoma (average 3715 steps), highlighting differences in physical activity levels based on tumor type.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of objective ambulation in lower extremity sarcoma patients with a continuous activity monitor: rationale and validation. Gundle, KR., Punt, SE., Conrad Iii, EU.[2020]

In a study of 12 pelvic sarcoma patients who underwent internal hemipelvectomy without pelvic reconstruction, an increase in psoas muscle size after surgery was significantly associated with improvements in gait speed, suggesting that muscle recovery plays a crucial role in functional rehabilitation.

The study also found that limb-length discrepancy (LLD) negatively impacted ambulatory function, indicating that minimizing LLD and focusing on psoas muscle strengthening could lead to better clinical outcomes post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in psoas muscle size and ambulatory function after internal hemipelvectomy without reconstruction. Dunbar, NJ., Zhu, YM., Madewell, JE., et al.[2023]

Custom prosthesis reconstruction after internal hemipelvectomy can significantly impact post-surgery walking function, and retaining or strengthening the psoas muscle is crucial for maximizing this function, as shown by simulations using a personalized neuromusculoskeletal model.

The study found that maintaining or increasing psoas muscle strength led to better walking outcomes, suggesting that surgical decisions regarding the psoas muscle should be carefully considered to improve the durability of custom prostheses and enhance recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computational evaluation of psoas muscle influence on walking function following internal hemipelvectomy with reconstruction. Vega, MM., Li, G., Shourijeh, MS., et al.[2023]

The study demonstrated that using a thigh-worn accelerometer (AX3) to assess ambulatory activity in 34 patients after sarcoma surgery is feasible and well-tolerated, providing valuable data on their walking patterns and activity levels at home.

Although the AX3 did not distinguish between different tumor sub-groups, it revealed that the pattern of walking (alpha) negatively correlated with disability, suggesting that monitoring walking patterns can help tailor rehabilitation efforts for better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Free-living monitoring of ambulatory activity after treatments for lower extremity musculoskeletal cancers using an accelerometer-based wearable - a new paradigm to outcome assessment in musculoskeletal oncology? Furtado, S., Godfrey, A., Del Din, S., et al.[2023]

Functional assessments in osteosarcoma patients can provide valuable insights that may improve treatment strategies, utilizing validated patient-reported outcomes and health state utility measures.

Emerging technologies like accelerometers show promise for real-world evaluation of patient activity, potentially correlating with traditional cancer treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in the Functional Assessment of Patients with Sarcoma. Ramsey, DC., Gundle, KR.[2021]

Limb salvage procedures for osteosarcoma patients lead to altered gait patterns, with significant reductions in knee flexion during loading compared to both unaffected limbs and healthy controls, indicating potential functional limitations post-surgery.

Muscular integrity, including strength and range of motion, was identified as the key predictor of functional outcomes after limb salvage surgery, while patients using the Stanmore SIMLES prostheses showed better ankle performance than those with the Stryker HMRS prostheses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of kinematic and kinetic patterns following limb salvage procedures for bone sarcoma. Carty, CP., Bennett, MB., Dickinson, IC., et al.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05054335

Patient-Specific Computational Walking Models in ... This trial studies the development of patient-specific computational walking models to improve the surgical planning and rehabilitation treatment of patients ...

2. withpower.com withpower.com/trial/phase-sarcoma-5-2019-d5bb1

Functional Assessment + X-Ray Imaging for Pelvic Sarcoma This trial studies the development of patient-specific computational walking models to improve the surgical planning and rehabilitation treatment of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11140731/

Changes in walking function and neural control following ... Experimental walking and CT scan data were collected pre- and post-surgery from a single participant with a pelvic sarcoma who received internal hemipelvectomy ...

4. biorxiv.org biorxiv.org/content/10.1101/2024.02.27.582423v1.full-text

Changes in Walking Function and Neural Control following ... Experimental walking and CT scan data were collected pre- and post-surgery from a single patient with a pelvic sarcoma who received internal ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9559731/

Computational evaluation of psoas muscle influence on ... Computational evaluation of psoas muscle influence on walking function following internal hemipelvectomy with reconstruction

6. mdpi.com mdpi.com/2075-4418/15/12/1452

Functional Outcomes and Activity Levels in Patients After ... The aim of this study was to investigate functional outcomes, including sport activity levels, and the impact of tumor grade, resection margins, adjuvant ...

7. repository.rice.edu repository.rice.edu/items/898115bc-136b-4557-8d7f-4cb50d14d76a

Predicting Post-surgery Walking Function of Pelvis Sarcoma ... In the first technical chapter (Chapter 2), a personalized musculoskeletal model was created to simulate the gait movement of a pelvic sarcoma patient. The ...

8. simtk.org simtk.org/projects/pelvic_sarcoma

Changes in Walking Function and Neural Control following ... These models were used to calculate the patient's pre- and post-surgery joint motions, joint moments, and muscle synergies. The calculated ...