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Trial Title:
Minimally-invasive Stabilization of Pelvic Metastases With Photodynamic Nails: A Multi-center Prospective Study of Functional Outcome
NCT ID:
NCT06083896
Condition:
Pelvic Metastasis
Conditions: Official terms:
Neoplasm Metastasis
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Photodynamic nails
Description:
stab incision is made at the entry site
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients must have histologically confirmed malignancy that is metastatic to the
peri-acetabular region of the pelvis. This would include metastatic carcinomas,
myeloma, and lymphoma.
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Patrick Lin, MD
Phone:
713-745-0088
Email:
plin@mdanderson.org
Investigator:
Last name:
Patrick Lin, MD
Email:
Principal Investigator
Start date:
October 6, 2023
Completion date:
January 1, 2029
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06083896
http://www.mdanderson.org
