Minimally-invasive treatment for pelvic metastases using photodynamic nails
Minimally-invasive Stabilization of Pelvic Metastases With Photodynamic Nails: A Multi-center Prospective Study of Functional Outcome
This study is testing if a new, less invasive treatment using special photodynamic nails can help people with pelvic metastases feel better and improve their function after three months.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06083896 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the early functional improvement in patients with pelvic metastases following the minimally-invasive placement of Illuminoss photodynamic nails. The primary objective is to assess functional outcomes at three months post-procedure, while secondary objectives include pain relief, radiographic stability of the implant, and monitoring for complications. The study will involve multiple centers and will track patient progress through various time points, including two weeks, six weeks, and six months after the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed malignancies and radiographically visible metastatic involvement of the periacetabular region.
Not a fit: Patients with uncontrolled intercurrent illnesses or those with specific exclusions such as HIV on effective treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the quality of life for patients with pelvic metastases by improving function and reducing pain.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in minimally-invasive techniques for treating metastatic conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Houston, Texas
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Patrick Lin, MD — M.D. Anderson Cancer Center
- Study coordinator: Patrick Lin, MD
- Email: plin@mdanderson.org
- Phone: (713) 745-0088
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.