Minimally-Invasive Stabilization for Pelvic Cancer

Overseen By Patrick Lin, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Uncontrolled illness, Pregnancy, Allergic reactions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special photodynamic nail, a minimally-invasive stabilization device, can improve well-being and function in patients with pelvic cancer three months post-surgery. The treatment targets individuals with cancer that has spread to the pelvic area, particularly around the hip joint. Eligible participants must have a confirmed cancer diagnosis from a previous biopsy and be able to undergo general anesthesia. They should also be capable of completing surveys before and after the procedure to report their condition. As a Phase 1 trial, the research focuses on understanding the treatment's effects in people, offering participants the chance to be among the first to receive this innovative treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the IlluminOss Photodynamic Nail System is safe for minimally-invasive stabilization of pelvic metastases?

Research has shown that using photodynamic nails (PDNs) to stabilize pelvic cancer spread is generally safe. In earlier studies, patients treated with PDNs quickly improved their mobility and experienced few complications. Another study found this method safe and effective for reducing symptoms and increasing patient comfort.

Additionally, PDNs appear less invasive than traditional methods, resulting in less blood loss and a reduced need for blood transfusions during surgery. These findings suggest that PDNs are well-tolerated and have demonstrated a good safety record in humans so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the minimally-invasive stabilization of pelvic metastases with photodynamic nails because it offers a groundbreaking approach to treating pelvic cancer. Unlike traditional surgical methods, which can be highly invasive and require lengthy recovery times, this method uses light-activated nails that can stabilize bones with minimal disruption to the body. This new technique promises quicker recovery and less pain for patients, making it a potentially significant advancement in managing bone metastases from pelvic cancer.

What evidence suggests that minimally-invasive stabilization with photodynamic nails is effective for pelvic cancer?

Research shows that photodynamic nails (PDNs) effectively treat cancer that has spread to the pelvic area. Studies have found that PDNs can reduce pain and improve patients' mobility and function. This minimally invasive method requires only small incisions, resulting in less blood loss and quicker recovery compared to traditional surgery. Photodynamic therapy, a component of this treatment, also helps shrink tumors and relieve pain. Early results suggest that patients experience significant improvements in their daily activities after the procedure. ^{1 2 3 5 6}

Who Is on the Research Team?

Patrick Lin, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with confirmed cancer that has spread to the pelvic bone near the hip. They must be able to sign consent, complete surveys, and have certain blood cell counts. It's not for those with recent severe illnesses, uncontrolled HIV, mental/social issues affecting compliance, or pregnant women due to anesthesia and radiation risks.

Inclusion Criteria

I am willing and able to complete surveys before and after surgery.

Your platelets are at least 50,000/mcL.

Your absolute neutrophil count is greater than or equal to 1,500/mcL.

Exclusion Criteria

I am HIV positive, on treatment, and my viral load is undetectable.

I am not pregnant due to the risks involved in the study.

I do not have any severe illnesses like recent pneumonia or heart attacks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Minimally-invasive placement of Illuminoss photodynamic nails for peri-acetabular pelvic metastasis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for functional improvement and pain relief at 2 weeks, 6 weeks, 3 months, and 6 months following the procedure

6 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Minimally-invasive Stabilization of Pelvic Metastases With Photodynamic Nails

Trial Overview The study tests if Illuminoss photodynamic nails can improve mobility early on after minimally-invasive surgery in patients whose cancer has spread to a specific area of the pelvis. The focus is on functional outcomes three months post-procedure.

Minimally-invasive Stabilization of Pelvic Metastases With Photodynamic Nails is already approved in United States, European Union for the following indications:

Approved in United States as IlluminOss Photodynamic Nail System for:

• Pelvic metastases stabilization
• Geriatric fragility fracture repair
• Pathologic fracture repair

Approved in European Union as IlluminOss Photodynamic Nail System for:

• Pelvic metastases stabilization
• Geriatric fragility fracture repair
• Pathologic fracture repair

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

Photodynamic therapy is an emerging anticancer technique that selectively targets and destroys cancerous tissue, showing promise for use in managing gastrointestinal tumors, particularly for eradicating micrometastases and residual lymph nodes after surgery.

Current research is focused on addressing practical challenges such as the behavior of photosensitizers in the body, the proper dosage of light needed for treatment, and the sensitivity of surrounding organs, with ongoing evaluations to determine its feasibility in surgical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-abdominal photodynamic therapy: from theory to feasibility. Evrard, S., Aprahamian, M., Marescaux, J.[2019]

In a study of 6 patients with severe acetabular defects, the use of photodynamic nails (PDNs) in total hip arthroplasty resulted in significant pain relief, with visual analogue pain scores improving from an average of 7.8 to 2.0 six weeks post-surgery.

Despite some complications, including two acetabular revisions, the overall outcomes suggest that PDN augmentation provides effective stability and function for patients with challenging pelvic defects, making it a valuable option for reconstructive surgeons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmenting Pathologic Acetabular Bone Loss With Photodynamic Nails to Support Primary Total Hip Arthroplasty. Heng, M., Fourman, MS., Mitrevski, A., et al.[2022]

In a Phase I study involving 54 patients with advanced intraperitoneal tumors, the maximum tolerated dose of intraoperative photodynamic therapy (PDT) was determined to be 3.75 J/cm2 of 514 nm green light, which was effective and safer than previous methods using red light.

After treatment, 30 out of 39 patients were alive at follow-up (median 22.1 months), and 9 patients were free of disease, indicating promising efficacy of PDT in this challenging patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I study of debulking surgery and photodynamic therapy for disseminated intraperitoneal tumors. DeLaney, TF., Sindelar, WF., Tochner, Z., et al.[2022]

The use of tumor-targeted and -activatable photosensitizers in photodynamic therapy (PDT) allows for precise treatment of metastatic cancer by activating the therapy specifically at the tumor site with near-infrared light.

This chapter presents innovative protocols for preclinical studies, particularly focusing on advanced-stage ovarian cancer, and introduces a unique in vivo imaging technique to monitor treatment responses and track micrometastases effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic Treatments for Disseminated Cancer Metastases Using Fiber-Optic Technologies. Kercher, EM., Spring, BQ.[2023]

Photodynamic therapy (PDT) shows promise as a treatment for microscopic peritoneal metastases in advanced epithelial ovarian cancer, potentially reducing recurrence rates after surgery and chemotherapy.

Challenges in developing intraperitoneal PDT include poor tolerance due to non-specific photosensitizers and the proximity of metastases to other organs, highlighting the need for targeted therapies and innovative illumination methods to improve safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intraperitoneal photodynamic therapy for peritoneal metastasis of epithelial ovarian cancer. Limits and future prospects]. Azaïs, H., Mordon, S., Collinet, P.[2022]

Intraperitoneal photodynamic therapy (IntraPDT) shows potential for treating peritoneal metastases, particularly in ovarian cancer, but requires more robust evidence to support its effectiveness and feasibility in clinical practice.

The development of targeted photosensitizers (PS) for specific cancer subtypes is crucial to minimize side effects on healthy tissues, while advancements in lighting technology could enhance the application of IntraPDT across various cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A global approach for the development of photodynamic therapy of peritoneal metastases regardless of their origin. Azaïs, H., Rebahi, C., Baydoun, M., et al.[2021]

Photodynamic therapy (PDT) demonstrated an 80% complete response rate at 3 months and a 71.4% rate at 1 year in treating premalignant lesions of the lower genital tract in 15 women, indicating its potential long-term efficacy.

While PDT was generally effective, there were some adverse events, including photosensitivity reactions in 13.3% of patients, suggesting that while it preserves normal anatomy and function, monitoring for side effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy for premalignant lesions of the vulva and vagina: A long-term follow-up study. Choi, MC., Kim, MS., Lee, GH., et al.[2019]

The study demonstrated that using single-fiber and multiple-fiber illuminators to deliver light to prostate tumors in rats resulted in a consistent light intensity distribution, with a variation of only +/- 14% compared to predictions from a photodosimetry model.

Using light wavelengths of 700 nm and above, the nine-fiber illuminator configuration improved the uniformity of light delivery to tumors, which is crucial for effective photodynamic therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodosimetry of interstitial light delivery to solid tumors. Fenning, MC., Brown, DQ., Chapman, JD.[2017]

In a pilot study involving 14 patients with recurrent or residual colorectal cancer, photodynamic therapy (PDT) provided significant pain relief for some patients, with notable results in those with unresectable pelvic recurrences and incomplete resections.

PDT was found to be safe and tolerable, showing potential for tumor destruction and management of pelvic malignancies, even in areas previously treated with radiation, suggesting it could be a valuable option in colorectal cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy in patients with colorectal cancer. Herrera-Ornelas, L., Petrelli, NJ., Mittelman, A., et al.[2019]

Photodynamic therapy effectively targets tumors in the gastrointestinal tract, using photosensitizers like porphyrins to reduce tumor size and achieve long-lasting remission in some cases.

Recent advancements include new photosensitizers that work with longer wavelengths of light for deeper tissue penetration, and the combination of photodynamic therapy with other treatments like laser therapy, radiotherapy, or chemotherapy to enhance efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy for gastrointestinal tumors. Wilson, JH., van Hillegersberg, R., van den Berg, JW., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11392488/

A Prospective Study of the IlluminOss Photodynamic Nail ... The stabilization of metastatic lesions in the periacetabular region can be successfully performed using percutaneous techniques. Photodynamic nails (PDNs) ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-08747

Minimally-Invasive Stabilization of Pelvic Metastases with ... This phase I trial tests the safety and effectiveness of photodynamic nails for the minimally-invasive stabilization of cancer that has spread from where it ...

3. hub.jbjs.org hub.jbjs.org/reader.php?rsuite_id=839eac28-4720-4181-a249-6fc76862bfe4

Assessing Pain and Functional Outcomes of Percutaneous ... Our group hypothesized that the use of percutaneous photodynamic nails (PDNs) would result in decreased pain, improved functional outcomes and ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0972978X24003210

Peri-operative outcomes of IlluminOss fixation for pelvic ... PBSS offers similar operative times, reduced blood loss, and decreased need for transfusions compared to open pelvic fixation methods.

5. withpower.com withpower.com/trial/phase-1-neoplasm-metastasis-9-2023-08d42

Minimally-Invasive Stabilization for Pelvic Cancer Photodynamic therapy (PDT), which is part of the treatment, has shown effectiveness in reducing pain and destroying tumor cells in patients with pelvic ...

6. mdanderson.org mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2023-0292.html?PageSpeed=noscript

Minimally-invasive stabilization of pelvic metastases with ... Study #2023-0292. Minimally-invasive stabilization of pelvic metastases with photodynamic nails: A multi-center prospective study of functional outcome.