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

M.D. Anderson Cancer Center

Status and phase: Enrolling; Phase 1

Conditions: Pelvic Metastasis

Treatments: Procedure: Photodynamic nails

Study type: Interventional

Funder types: Other

Identifiers

NCT06083896

2023-0292

NCI-2023-08747 (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)