RECRUITING

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

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Conditions

Pelvic Metastasis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-10-06
Study Completion:2029-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06083896

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Age ≥18 years (Illuminoss is approved only for skeletally mature patients)
  3. * Suitable candidate for general anesthesia
  4. * Ability to understand and the willingness to sign a written informed consent document.
  5. * Able and willing to fill out pre-operative and post-operative functional outcome surveys
  6. * Absolute neutrophil count ≥ 1,500/mcL
  7. * Platelets ≥ 50,000/mcL
  1. * Patients with uncontrolled intercurrent illness (e.g., recent pneumonia or myocardial infarction that would significantly increase risk of general anesthesia)
  2. * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  3. * Patients with psychiatric illness/social situations that would limit compliance with study requirements.
  4. * Pregnant women are excluded from this study because of the risk of general anesthesia and radiation exposure (fluoroscopy) to the fetus
  5. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to dental resins or PET.

Contacts and Locations

Study Contact

Patrick Lin, MD
CONTACT
(713) 745-0088
plin@mdanderson.org

Principal Investigator

Patrick Lin, MD
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Patrick Lin, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-06
Study Completion Date2029-01-01

Study Record Updates

Study Start Date2023-10-06
Study Completion Date2029-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Pelvic Metastasis