Clinical trial NCT06083896: Minimally-invasive Stabilization of Pelvic Metastases With Photodynamic Nails: A Multi-center Prospective Study of Functional Outcome
Official title: Minimally-invasive Stabilization of Pelvic Metastases With Photodynamic Nails: A Multi-center Prospective Study of Functional Outcome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Pelvic Metastasis
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

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.

Primary outcomes:
measure: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
timeFrame: Through study completion, up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Patrick Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: