120 Participants Needed

Pegsitacianine Imaging for Head and Neck Cancer

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Overseen ByBaran Sumer, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Texas Southwestern Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot take medications with a high chance of liver damage during the study. It's best to discuss your specific medications with the study team.

What data supports the effectiveness of the treatment Pegsitacianine for head and neck cancer?

While there is no direct data on Pegsitacianine, similar imaging agents have shown promise in improving the detection and treatment of head and neck cancers. For example, nanoparticles used in imaging have helped identify cancerous tissues and improve surgical precision, which could suggest potential benefits for Pegsitacianine in similar applications.12345

How does Pegsitacianine Imaging differ from other treatments for head and neck cancer?

Pegsitacianine Imaging is unique because it uses a near-infrared (NIR) fluorescence technique to help visualize tumors during surgery, which can improve the precision of tumor removal. This approach is different from traditional treatments that do not provide real-time imaging guidance during surgical procedures.678910

What is the purpose of this trial?

This is a non-randomized, open-label, single-center, safety and imaging feasibility study of Pegsitacianine, an intraoperative fluorescence imaging agent.

Eligibility Criteria

Adults over 18 with certain types of head and neck cancers, including those without a known primary tumor location but with metastatic disease. Participants must have proper organ function, agree to use contraception, and avoid alcohol before the trial. Those very ill or unable to consent are excluded.

Inclusion Criteria

Biopsy-confirmed diagnosis, for primary or recurrent disease (or high clinical suspicion in the opinion of the Investigator)
Documented negative serum pregnancy test for women of childbearing potential
Adequate potential for follow up
See 5 more

Exclusion Criteria

Life expectancy <12 weeks
Alcohol consumption within 72 hours before Pegsitacianine administration
Lab values or any sign, symptom, or medical condition that in the opinion of the PI would prevent surgical resection
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Single dose of 1 mg/kg Pegsitacianine administered 6-100 hours prior to surgery for imaging primary tumors

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including vital signs, physical examination, and laboratory tests

10 days
Multiple visits (in-person and virtual)

Long-term monitoring

Participants are monitored for diagnostic performance and safety over a 5-year period

5 years

Treatment Details

Interventions

  • Pegsitacianine
Trial Overview The study is testing Pegsitacianine as an imaging agent during surgery for cancer detection in patients with head and neck cancers. It's an open-label trial where all participants receive the agent to assess its safety and effectiveness in identifying cancerous tissue.
Participant Groups
2Treatment groups
Active Control
Group I: Part 1 - Cohort AActive Control1 Intervention
In Part 1 the single dose of 1 mg/kg of pegsitacianine given 6-300 hours prior to surgery will be used to image primary tumors in patients with HNSCC to evaluated to verify the diagnostic performance of pegsitacianine fluorescence imaging for detecting primary tumors and metastatic lymph nodes.
Group II: Part 2 - Cohort BActive Control1 Intervention
In Part 2, pegsitacianine the single dose of 1 mg/kg of given 6-300 hours prior to surgery will be used to in patients with unknown primary cancer of the head and neck. These patients typically undergo exam under anesthesia with a laryngoscopy as well as panendoscopy for identifying the source of the metastatic cancer found in the cervical nodes. The diagnostic performance of pegsitacianine fluorescence imaging for detecting primary tumors and metastatic lymph nodes in these patients will be evaluated. All the available data to date will be used to decide the additional tumor type(s), number of patients per tumor type, and number of Group(s) to be enrolled.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

64 Cu-porphysome nanoparticles provide enhanced imaging of cancerous tissues and lymph nodes in a rabbit model of head and neck cancer, allowing for better detection during positron emission tomography (PET) imaging.
These nanoparticles also enable real-time fluorescence visualization of tumors during surgery, helping surgeons accurately identify cancerous areas and preserve healthy tissue, which can improve surgical outcomes.
Multimodal Nanoparticle for Primary Tumor Delineation and Lymphatic Metastasis Mapping in a Head-and-Neck Cancer Rabbit Model.Muhanna, N., MacDonald, TD., Chan, H., et al.[2019]
The multimodal porphyrin lipoprotein-mimicking nanoparticle (PLP) significantly improves the accuracy of diagnosing head and neck cancer (HNC) by enabling precise detection of primary tumors and metastatic lymph nodes, as demonstrated in a rabbit model.
PLP-based photodynamic therapy (PDT) resulted in a remarkable increase in tumor cell apoptosis (73.2% vs. 7.1% with PLP alone) and successfully eradicated primary tumors without harming surrounding healthy tissues, indicating its potential for effective HNC treatment.
Multimodal Image-Guided Surgical and Photodynamic Interventions in Head and Neck Cancer: From Primary Tumor to Metastatic Drainage.Muhanna, N., Cui, L., Chan, H., et al.[2016]
The study demonstrated that 100 nm theranostic nanoparticles can enhance radiation therapy for head and neck squamous cell carcinoma, showing reduced tumor growth and lung metastasis in rat models.
These nanoparticles provide both imaging capabilities and therapeutic benefits, allowing for better radiation therapy planning and improved treatment efficacy, as evidenced by their optimal tumor uptake and effectiveness in reducing tumor size.
X-ray and MR Contrast Bearing Nanoparticles Enhance the Therapeutic Response of Image-Guided Radiation Therapy for Oral Cancer.Sharma, G., Razeghi Kondelaji, MH., Sharma, GP., et al.[2023]

References

Multimodal Nanoparticle for Primary Tumor Delineation and Lymphatic Metastasis Mapping in a Head-and-Neck Cancer Rabbit Model. [2019]
Multimodal Image-Guided Surgical and Photodynamic Interventions in Head and Neck Cancer: From Primary Tumor to Metastatic Drainage. [2016]
X-ray and MR Contrast Bearing Nanoparticles Enhance the Therapeutic Response of Image-Guided Radiation Therapy for Oral Cancer. [2023]
Met-Targeted Dual-Modal MRI/NIR II Imaging for Specific Recognition of Head and Neck Squamous Cell Carcinoma. [2021]
Photoacoustic and Magnetic Resonance Imaging of Hybrid Manganese Dioxide-Coated Ultra-small NaGdF4 Nanoparticles for Spatiotemporal Modulation of Hypoxia in Head and Neck Cancer. [2021]
Characterization and optimization of mTHPP nanoparticles for photodynamic therapy of head and neck cancer. [2011]
In vivo cancer imaging by poly(ethylene glycol)-b-poly(ɛ-caprolactone) micelles containing a near-infrared probe. [2022]
Hybrid polypeptide micelles loading indocyanine green for tumor imaging and photothermal effect study. [2022]
Enabling In Vivo Optical Imaging of an Osmium Photosensitizer by Micellar Formulation. [2023]
Tumor-targeted polydiacetylene micelles for in vivo imaging and drug delivery. [2018]
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