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

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Primary Purpose

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Photodynamic nails

About this trial

This is an interventional supportive care trial for Pelvic Metastasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

MD Anderson Cancer CenterRecruiting

Outcomes

Primary Outcome Measures

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Secondary Outcome Measures

Full Information

NCT ID

NCT06083896

First Posted

October 9, 2023

Last Updated

October 16, 2023

Sponsor

M.D. Anderson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT06083896

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 6, 2023 (Actual)

Primary Completion Date

January 1, 2027 (Anticipated)

Study Completion Date

January 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. 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

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 Evaluate whether the procedure relieves pain Evaluate radiographic stability of the implant Evaluate functional outcome at earlier time points (2 weeks or 6 weeks) and at 6 months and possibly later time points Evaluate reoperation rate and complications

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Metastasis

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Photodynamic nails

Intervention Description

stab incision is made at the entry site

Primary Outcome Measure Information:

Title

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time Frame

Through study completion, up to one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Patrick Lin, MD

Phone

(713) 745-0088

Email

plin@mdanderson.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patrick Lin, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patrick Lin, MD

Phone

713-745-0088

Email

plin@mdanderson.org

First Name & Middle Initial & Last Name & Degree

Patrick Lin, MD

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

MD Anderson Cancer Center

Pelvic Metastasis

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial