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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT06083896
Collaborator
(none)
50
Enrollment
1
Location
62.9
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Photodynamic nails
 Phase 1

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Minimally-invasive Stabilization of Pelvic Metastases With Photodynamic Nails: A Multi-center Prospective Study of Functional Outcome
Actual Study Start Date :
Oct 6, 2023
Anticipated Primary Completion Date :
Jan 1, 2027
Anticipated Study Completion Date :
Jan 1, 2029

Outcome Measures

Primary Outcome Measures

  1. Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [Through study completion, up to one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 MD Anderson Cancer Center Houston Texas United States 77030

Sponsors and Collaborators

  • M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Patrick Lin, MD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT06083896
Other Study ID Numbers:
  • 2023-0292
  • NCI-2023-08747
First Posted:
Oct 16, 2023
Last Update Posted:
Oct 18, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasm Metastasis

Study Results

No Results Posted as of Oct 18, 2023