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

NCT ID: NCT06083896

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-06
• Study Completion Date: 2029-01-01

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 procedure

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 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

Conditions

Pelvic Metastasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Interventions

Photodynamic nails

stab incision is made at the entry site

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Lin, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

MD Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Patrick Lin, MD

Role: CONTACT

plin@mdanderson.org

(713) 745-0088

Facility Contacts

Patrick Lin, MD

Role: primary

plin@mdanderson.org

713-745-0088

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

NCI-2023-08747

Identifier Type: OTHER

Identifier Source: secondary_id

2023-0292

Identifier Type: -

Identifier Source: org_study_id