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RecruitingPhase 1NCT06083896

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

Sponsor

M.D. Anderson Cancer Center

Enrollment

50 participants

Start Date

Oct 6, 2023

Study Type

INTERVENTIONAL

Conditions

Pelvic Metastasis

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 procedure

Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria5

  • 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.

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Interventions

PROCEDUREPhotodynamic nails

stab incision is made at the entry site

Locations(1)

MD Anderson Cancer Center

Houston, Texas, United States

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NCT06083896