Status:
RECRUITING
Minimally-invasive Stabilization of Pelvic Metastases With Photodynamic Nails: A Multi-center Prospective Study of Functional Outcome
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Pelvic Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Determine whether patients exhibit early functional improvement after minimally-invasive placement of Illuminoss photodynamic nails for peri-acetabular pelvic metastasis at 3 months following procedur...
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 mo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06083896
Start Date
October 6 2023
End Date
January 1 2029
Last Update
August 13 2025
Active Locations (1)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77030