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

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment Minimally-invasive Stabilization of Pelvic Metastases With Photodynamic Nails?

Photodynamic therapy (PDT), which is part of the treatment, has shown effectiveness in reducing pain and destroying tumor cells in patients with pelvic malignancies, as demonstrated in studies involving colorectal cancer. This suggests that PDT can be a safe and tolerable option for managing pelvic metastases. ^{1 2 3 4 5}

Is the treatment using photodynamic nails generally safe for humans?

The use of photodynamic therapy (PDT), which is related to photodynamic nails, has been shown to be safe and tolerable in patients with pelvic malignancies, providing pain relief and tumor destruction without significant safety concerns. ^{2 3 4 6 7}

What makes the Minimally-invasive Stabilization of Pelvic Metastases With Photodynamic Nails treatment unique?

This treatment is unique because it combines a minimally-invasive approach with photodynamic therapy, which uses light to activate a chemical that destroys cancer cells. Unlike traditional treatments, it specifically targets pelvic metastases with a novel 'nail' system that stabilizes the bone while delivering the therapy. ^{1 3 8 9 10}

Research Team

Patrick Lin, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

I am 18 years old or older.

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

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)

Treatment Details

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+

Findings from Research

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]

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]

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 (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]

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]

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]

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]

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 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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

[Intraperitoneal photodynamic therapy for peritoneal metastasis of epithelial ovarian cancer. Limits and future prospects]. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Phase I study of debulking surgery and photodynamic therapy for disseminated intraperitoneal tumors. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Photodynamic therapy in patients with colorectal cancer. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Photodynamic therapy for premalignant lesions of the vulva and vagina: A long-term follow-up study. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

A global approach for the development of photodynamic therapy of peritoneal metastases regardless of their origin. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Augmenting Pathologic Acetabular Bone Loss With Photodynamic Nails to Support Primary Total Hip Arthroplasty. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Photodosimetry of interstitial light delivery to solid tumors. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Photodynamic Treatments for Disseminated Cancer Metastases Using Fiber-Optic Technologies. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Intra-abdominal photodynamic therapy: from theory to feasibility. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Photodynamic therapy for gastrointestinal tumors. [2019]