Dual Imaging for Head and Neck Cancer

Overseen By Nicole Jones

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Vanderbilt-Ingram Cancer Center

Must not be taking: Antiarrhythmics

Disqualifiers: MI, CHF, Liver disease, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 week

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two imaging techniques to improve the detection of head and neck cancer during surgery. It combines a special radioactive imaging agent, Indium In 111 Panitumumab, with a fluorescent dye, Panitumumab-IRDye800, to enhance the visibility of cancer cells. The goal is to determine if using both techniques together provides a clearer picture of the cancer. Individuals with confirmed squamous cell carcinoma of the head and neck who are planning surgery might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking certain heart rhythm medications (like quinidine, procainamide, dofetilide, amiodarone, or sotalol), you may not be eligible to participate.

What prior data suggests that these imaging techniques are safe for detecting head and neck cancer?

In earlier studies, researchers tested indium In 111 panitumumab for safety in patients with head and neck cancer. Research shows it is generally well-tolerated, meaning most people do not experience serious side effects. These studies have not found major safety issues, but it's important to remember that this is early research, and more information is needed.

For panitumumab-IRDye800, research indicates it has a safety profile similar to panitumumab, which is already used in other treatments. This suggests it is likely safe. Studies have not shown significant side effects when using panitumumab-IRDye800 for imaging during surgery. However, as with any new treatment, participating in trials helps researchers gather more information to confirm its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they combine advanced imaging techniques with targeted therapy to enhance the detection and surgical removal of head and neck cancer. Unlike traditional treatments that primarily rely on visual inspection and basic imaging, this approach uses Indium In 111 Panitumumab and Panitumumab-IRDye800 to illuminate cancer cells, making them more visible during surgery. This dual imaging strategy enhances precision, potentially improving surgical outcomes by ensuring more complete tumor removal while sparing healthy tissue. This innovative method could lead to more effective treatments with fewer side effects for patients.

What evidence suggests that these imaging techniques are effective for detecting head and neck cancer?

In this trial, participants will receive both 111In-panitumumab and panitumumab-IRDye800 as part of the diagnostic process. Research has shown that the imaging method 111In-panitumumab with SPECT/CT scans can more accurately identify cancerous lymph nodes in patients with head and neck cancer. This method targets tumor cells, making them visible in scans and improving detection. Meanwhile, studies have shown that panitumumab-IRDye800 highlights cancer cells during surgery, helping surgeons distinguish between cancerous and normal tissue. Both imaging techniques hold promise for better detection and treatment of head and neck cancer during surgery. ^{1 6 7 8 9}

Who Is on the Research Team?

Eben Rosenthal, MD

Principal Investigator

Vanderbilt University/Ingram Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 19 with any stage of head and neck squamous cell carcinoma, scheduled for surgery. It includes those with recurrent disease or a new primary cancer who can sign consent. Excluded are pregnant individuals, those with certain heart risks, severe kidney issues, recent serious cardiovascular events, allergies to iodine or past bad reactions to monoclonal antibodies.

Inclusion Criteria

I have been diagnosed with squamous cell carcinoma in my head or neck.

I am scheduled for surgery to remove a tumor in my head or neck, including if it's a recurrence or a new primary tumor.

I am 19 years old or older.

Exclusion Criteria

Magnesium or potassium lower than the normal institutional values

Evidence of QT prolongation on pretreatment electrocardiogram (ECG) (greater than 440 ms in males or greater than 450 ms in females)

History of allergies to iodine

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive panitumumab-IRDye800 IV over 15 minutes followed by 111In-panitumumab IV on day 0, then undergo SPECT/CT between days 1 and 5, prior to standard of care surgical resection with fluorescence imaging

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Indium In 111 Panitumumab
• Panitumumab-IRDye800

Trial Overview The trial tests two imaging techniques in detecting head and neck cancer during surgery: a radioactive agent (111In-panitumumab) used with SPECT/CT scans and a fluorescent dye-linked antibody (panitumumab-IRDye800). The goal is to see if combining these methods improves disease detection.

How Is the Trial Designed?

Group I: Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT) Experimental Treatment 6 Interventions

Patients receive panitumumab-IRDye800 IV over 15 minutes followed by 111In-panitumumab IV on day 0. Patients then undergo SPECT/CT between days 1 and 5, prior to standard of care surgical resection with fluorescence imaging.

Who Is Running the Clinical Trial?

Vanderbilt-Ingram Cancer Center

Lead Sponsor

Trials

221

Recruited

64,400+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Photoacoustic molecular imaging (PAMI) using panitumumab conjugated to IRDye800CW effectively identified metastatic lymph nodes (LNs) in patients with head and neck squamous cell carcinoma (HNSCC), showing a 5-fold higher signal intensity in metastatic LNs compared to benign ones.

The study analyzed 53 LNs and found that PAMI could distinguish metastatic from benign LNs with high accuracy, achieving an area under the receiver-operating-characteristic curve of 0.96, suggesting its potential as a reliable tool for detecting occult metastases during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photoacoustic Molecular Imaging for the Identification of Lymph Node Metastasis in Head and Neck Cancer Using an Anti-EGFR Antibody-Dye Conjugate. Nishio, N., van den Berg, NS., Martin, BA., et al.[2023]

In a study involving 24 patients with head and neck squamous cell carcinoma, a fixed dose of 50 mg of the fluorescently labeled antibody panitumumab-IRDye800CW was identified as the optimal dose for enhancing fluorescence during surgery.

The study found that reducing the time between infusion and surgery to within 2 days significantly increased the fluorescence intensity of the tumors, suggesting that timing is crucial for effective imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal Dosing Strategy for Fluorescence-Guided Surgery with Panitumumab-IRDye800CW in Head and Neck Cancer. Nishio, N., van den Berg, NS., van Keulen, S., et al.[2021]

In a pilot study involving seven patients with squamous cell tumors, radiolabeled antibodies targeting carcino-embryonic antigen (CEA) successfully identified all five primary tumors and two out of three secondary tumors, demonstrating effective imaging capabilities.

The study showed no false positive results and highlighted that serum or tissue CEA levels did not consistently correlate with imaging success, suggesting the potential for further research into more specific tumor antigens and imaging techniques for head and neck cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Head and neck cancer localization with indium labelled carcinoembryonic antigen: a pilot project. Timon, CI., McShane, D., Hamilton, D., et al.[2016]

A study using a fluorescently-labeled tumor-targeting agent, panitumumab-IRDye800CW, showed that it significantly enhances the identification of metastatic lymph nodes (LNs) in head and neck cancer patients during surgery.

This molecular imaging technique allows for a more focused evaluation of LNs, potentially improving prognostic accuracy compared to traditional methods of neck dissection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical molecular imaging can differentiate metastatic from benign lymph nodes in head and neck cancer. Nishio, N., van den Berg, NS., van Keulen, S., et al.[2022]

The study evaluated the safety and stability of panitumumab-IRDye800CW, a near-infrared fluorescent dye conjugated to an approved therapeutic antibody, in 81 cancer patients over a 4.5-year period, finding a low adverse event rate of 7.4%, similar to that of panitumumab alone.

The conjugate demonstrated stability and safety for up to 54 months, supporting the potential for using therapeutic antibodies as diagnostic imaging agents with minimal additional toxicity concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Stability of Antibody-Dye Conjugate in Optical Molecular Imaging. Pei, J., Juniper, G., van den Berg, NS., et al.[2022]

Panitumumab-IRDye800 has been developed as an effective intraoperative optical imaging agent for detecting EGFR-expressing tumors, showing high specificity and sensitivity in various mouse models with different levels of EGFR expression.

The study demonstrated a strong correlation between the level of EGFR expression in tumors and the uptake of the panitumumab-IRDye800, indicating its potential for precise tumor visualization during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthesis and biological evaluation of panitumumab-IRDye800 conjugate as a fluorescence imaging probe for EGFR-expressing cancers. Bhattacharyya, S., Patel, N., Wei, L., et al.[2020]

The study demonstrated that the fluorescently labeled antibodies cetuximab-IRDye800CW and panitumumab-IRDye800CW are safe for use in surgical imaging, with minimal toxicities observed in 27 patients with head and neck squamous cell carcinoma.

Both antibodies showed similar pharmacodynamic properties, and no significant safety concerns were raised, indicating potential for other therapeutic antibodies to be repurposed for imaging with limited preclinical data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of panitumumab-IRDye800CW and cetuximab-IRDye800CW for fluorescence-guided surgical navigation in head and neck cancers. Gao, RW., Teraphongphom, N., de Boer, E., et al.[2019]

In a phase I study involving 19 patients with advanced squamous cell carcinoma of the head and neck, the combination of panitumumab, carboplatin, and escalating doses of paclitaxel with intensity-modulated radiotherapy (IMRT) showed a high overall complete clinical response rate of 95%.

The treatment was generally well tolerated, with the maximum tolerated dose of paclitaxel identified at 30 mg/m², although all patients experienced significant side effects like mucositis and oral pain, indicating the need for careful management of these toxicities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I dose-finding study of paclitaxel with panitumumab, carboplatin and intensity-modulated radiotherapy in patients with locally advanced squamous cell cancer of the head and neck. Wirth, LJ., Allen, AM., Posner, MR., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05901545

Evaluating 111In Panitumumab for Nodal Staging in Head ... Using 111In-panitumumab with SPECT/CT imaging may improve identification of sentinel lymph nodes in patients with head and neck squamous cell cancer undergoing ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05945875

Study Details | NCT05945875 | Evaluating the Use of Dual ... This phase I trial evaluates the safety and effectiveness of using two imaging techniques, indium In 111 panitumumab (111In-panitumumab) with single photon ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11374632/

Targeted radionuclide therapy for head and neck ... This study concluded that panitumumab in combination with cisplatin chemoradiotherapy is well-tolerated and demonstrates improved clinical ...

4. stanfordhealthcare.org stanfordhealthcare.org/trials/s/NCT04840472.html

Study Evaluating 111In-Panitumumab for Nodal Staging in ... The primary purpose of the study is to assess the safety of 111In-panitumumab as a molecular imaging agent in patients with Head and Neck Squamous Cell ...

5. trialstoday.org trialstoday.org/search/results?status=recruiting&gender=&age=&zip=&radius=25&condition=&healthy=&type=&interventionalpurpose=&observationalmodel=&query=University%20of%20Iowa%20Neurology&page=eJyLViooSi3LzC8tVtJR8nMOMTAxNjMyNDdT0tG1hAEcTDM9EwtLMwMTHUNzUzMzCxMLAxDQUcpLLjEwM7cwN7M0UIoFAHxPFnI-

Save Selected Using 111In-panitumumab with SPECT/CT imaging may improve identification of sentinel lymph nodes in patients with head and neck squamous cell cancer undergoing ...

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2021-05694

111In Panitumumab for Nodal Staging in Head and Neck ... This phase I trial studies the side effects of 111In-panitumumab for nodal staging of head of neck cancer. Often cancerous cells have unusual proteins on ...

7. theranostictrials.org theranostictrials.org/studies/cl74bp9il0253ajjfrinr5n8z/study/NCT05901545

NCT05901545 This phase I trial tests the safety and effectiveness of indium In 111 panitumumab (111In-panitumumab) for identifying the first lymph nodes to which cancer ...

8. vicc.org vicc.org/clinical-trials/search?cancer-type=Endocrine&f%5B0%5D=disease_site%3AHead/Neck&f%5B1%5D=drug_name%3ANot%20Available&f%5B2%5D=drug_name%3APF-06840003&keys=

Clinical Trials Search at Vanderbilt-Ingram Cancer Center This phase I trial tests the safety and effectiveness of indium In 111 panitumumab (111In-panitumumab) for identifying the first lymph nodes to which cancer ...

9. jnm.snmjournals.org jnm.snmjournals.org/content/early/2021/01/22/jnumed.120.253146

A Phase 1 and Biodistribution Study of ABT-806i, An Indium ... This study assessed safety, biodistribution and pharmacokinetics of indium-111 (111 ... head and neck cancer and experienced a partial response.