Pelvic MetastasisPhase 1NCT06083896
Minimally-invasive Stabilization of Pelvic Metastases With Photodynamic Nails: A Multi-center Prospective Study of Functional Outcome
A Phase 1 study testing Photodynamic nails in people with Pelvic Metastasis, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvic Metastasis
- What is being tested?
- Photodynamic nails
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2023to 1 Jan 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Patrick Lin, MD, 713-745-0088, plin@mdanderson.org
Patrick Lin, MD
About this study
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
Read the detailed description
Primary Objectives
- 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
- Conditions
- Pelvic Metastasis
- Being tested
- Photodynamic nails
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic nailsProcedure or surgery
stab incision is made at the entry site
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion, up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start6 Oct 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic MetastasisStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Lin, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083896
- Sponsor's protocol ID
- 2023-0292
- Other IDs
- NCI-2023-08747
- Status last verified
- Aug 2026
- First submitted
- 9 Oct 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally-invasive Stabilization of Pelvic Metastases With Photodynamic Nails: A Multi-center Prospective Study of Functional Outcome
- ClinicalTrials.gov ID
- NCT06083896
- Acronym / sponsor ID
- 2023-0292
- Conditions
- Pelvic Metastasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photodynamic nailsstab incision is made at the entry site | Procedure or surgery | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Lin, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Photodynamic nails in people with Pelvic Metastasis, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Lin, MD ((713) 745-0088, plin@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.