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Actively Recruiting

Phase 1
Age: 18Years +
All Genders
ID06083896

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

Led by M.D. Anderson Cancer Center · Updated on 2026-03-02

50

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the early functional improvement in patients with peri-acetabular pelvic metastasis after minimally-invasive placement of Illuminoss photodynamic nails. This multi-center prospective study aims to assess functional outcomes at 3 months post-procedure and also looks at pain relief, radiographic stability, and complications related to the implant. The trial is sponsored by M.D. Anderson Cancer Center and is conducted as a Phase 1 interventional study. The study involves placing photodynamic nails through a stab incision at the entry site in patients with pelvic metastases. The procedure uses general anesthesia and is minimally invasive. Researchers will evaluate the patients functional outcomes at various time points, including 2 weeks, 6 weeks, 3 months, 6 months, and possibly later. The study also monitors for reoperation rates and complications associated with the implant. Participants will be asked to complete pre-operative and post-operative functional outcome surveys. Safety is closely monitored through tracking adverse events graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, up to one year after the procedure. The study requires participants to be able to understand and consent, and their blood counts will be checked to ensure eligibility. Overall participation involves regular assessments to observe functional improvements and implant stability.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must have a confirmed diagnosis of cancer from prior biopsy of the primary tumor or metastatic site, including carcinoma, myeloma, or lymphoma
  • Metastatic involvement must be visible near the hip socket on imaging
  • Age 18 years or older
  • Suitable candidate for general anesthesia
  • Able to understand and willing to sign informed consent
  • Willing to complete pre- and post-operative functional surveys
  • Absolute neutrophil count of at least 1,500/mcL
  • Platelet count of at least 50,000/mcL
Not Eligible

You will not qualify if you...

  • Patients with uncontrolled illnesses that increase anesthesia risk, such as recent pneumonia or heart attack
  • Pregnant women due to risks from anesthesia and fluoroscopy
  • Patients with psychiatric or social issues limiting study compliance
  • History of allergic reactions to materials similar to dental resins or PET
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible

Research Team

P

Patrick Lin, MD

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