Minimally-invasive Stabilization of Pelvic Metastases With Photodynamic Nails: A Multi-center Prospective Study of Functional Outcome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Photodynamic nails.
- Who it may be relevant to
- Registry conditions: Pelvic Metastasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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
1. Evaluate whether the procedure relieves pain 2. Evaluate radiographic stability of the implant 3. Evaluate functional outcome at earlier time points (2 weeks or 6 weeks) and at 6 months and possibly later time points 4. Evaluate reoperation rate and complications
Interventions
- Procedure Photodynamic nails
stab incision is made at the entry site
Primary outcome measures
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [Time frame: Through study completion, up to one year]
Eligibility criteria
Inclusion criteria
- Patients must have a histologically confirmed malignancy from prior biopsy of the primary tumor or a metastatic site. Patients with carcinoma, myeloma, and lymphoma may be included in the study. Patients should have metastatic involvement of the periacetabular region that is visible radiographically. Biopsy of acetabular disease is not required for this study.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- MD Anderson Cancer Center — Houston
Identifiers
NCT: NCT06083896 · 2023-0292 · NCI-2023-08747