Minimally-invasive Stabilization of Pelvic Metastases With Photodynamic Nails: A Multi-center Prospective Study of Functional Outcome

Study Overview
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Brief Summary
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Determine whether patients exhibit early functional improvement after minimally-invasive placement of Illuminoss photodynamic nails for peri-acetabular pelvic metastasis at 3 months following procedure

Detailed Description
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Primary Objectives 1. Evaluate whether patients exhibit early functional improvement after minimally-invasive placement of Illuminoss photodynamic nails for peri-acetabular pelvic metastasis at 3 months following procedure Secondary Objectives Evaluate whether the procedure relieves pain Evaluate radiographic stability of the implant Evaluate functional outcome at earlier time points (2 weeks or 6 weeks) and at 6 months and possibly later time points Evaluate reoperation rate and complications

Official Title
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Minimally-invasive Stabilization of Pelvic Metastases With Photodynamic Nails: A Multi-center Prospective Study of Functional Outcome

Conditions
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Pelvic Metastasis

Intervention / Treatment
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* Procedure: Photodynamic nails


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have histologically confirmed malignancy that is metastatic to the peri-acetabular region of the pelvis. This would include metastatic carcinomas, myeloma, and lymphoma. Age ≥18 years (Illuminoss is approved only for skeletally mature patients) Suitable candidate for general anesthesia Ability to understand and the willingness to sign a written informed consent document. Able and willing to fill out pre-operative and post-operative functional outcome surveys Absolute neutrophil count ≥ 1,500/mcL Platelets ≥ 50,000/mcL Exclusion Criteria: Patients with uncontrolled intercurrent illness (e.g., recent pneumonia or myocardial infarction that would significantly increase risk of general anesthesia) Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Patients with psychiatric illness/social situations that would limit compliance with study requirements. Pregnant women are excluded from this study because of the risk of general anesthesia and radiation exposure (fluoroscopy) to the fetus History of allergic reactions attributed to compounds of similar chemical or biologic composition to dental resins or PET.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Photodynamic nails|stab incision is made at the entry site|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |  | Through study completion, up to one year |