PET Imaging Agent for Head and Neck Cancer

Overseen By Nicole Jones

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Vanderbilt-Ingram Cancer Center

Must be taking: Cetuximab

Disqualifiers: MI, CVA, CHF, liver disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new PET imaging agent to enhance the diagnosis of head and neck squamous cell carcinoma (HNSCC), particularly when current scans are unclear. The researchers aim to determine if this agent can more accurately identify cancerous areas, reducing unnecessary biopsies and improving treatment planning. Participants will receive cetuximab, a known targeted therapy, before using the new agent for imaging. The trial seeks individuals with head and neck cancer who have unclear results from standard imaging tests. 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 new imaging agent.

Do I have to stop taking 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 this PET imaging agent is safe for patients with head and neck cancer?

Research has shown that the PET imaging agent \[18F\]NOTA-ABY030 is undergoing testing for safety in humans. The main goal is to evaluate its effectiveness and safety. This agent aims to help doctors see tumors more clearly on scans. Researchers are closely monitoring its safety, but detailed safety information remains limited due to the early stage of research.

This trial is in its first phase, focusing primarily on safety. Researchers are studying how the body processes the agent and identifying any side effects. It is important to note that any new drug or agent begins with these early tests to ensure safety before progressing to larger studies. As research continues, more safety information will become available. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it uses a PET imaging agent, [18F]NOTA-ABY-030, to enhance the diagnostic capabilities for head and neck cancer. Unlike traditional imaging methods, which may struggle to clearly identify metastatic or primary lesions, this agent is designed to improve sensitivity and specificity in detecting cancerous cells. The trial also aims to optimize the timing and dosage of this imaging agent, potentially leading to more accurate and safer diagnostic protocols for patients with head and neck squamous cell carcinoma. This could be a game-changer in diagnosing and monitoring this type of cancer more effectively.

What evidence suggests that this PET imaging agent is effective for head and neck cancer?

Research has shown that [18F]NOTA-ABY-030 is a promising new tool for PET scans used to examine head and neck cancer. This trial will evaluate [18F]NOTA-ABY-030 in combination with cetuximab. The imaging agent targets a protein called EGFR, which aids cancer cell growth, and reduces background noise in images, potentially making tumors easier to see. Early results suggest this tool could outperform traditional methods like CT or MRI scans in tumor detection. This improvement could help doctors make better treatment decisions and reduce unnecessary procedures like biopsies. While data collection continues, the tool's design suggests it could be more effective in identifying cancerous areas. ^{6 7 8 9 10}

Who Is on the Research Team?

Eben Rosenthal, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for patients with head and neck squamous cell carcinoma who have unclear results from standard imaging. Participants must be suitable for PET/CT scans and willing to receive a cetuximab loading dose before the investigational imaging agent.

Inclusion Criteria

Have acceptable lab values: Hemoglobin ≥ 9gm/dL, White blood cell count > 3000/mm3, Platelet count ≥ 100,000/mm3, Serum creatinine ≤ 1.5 times upper reference range, Potassium, Magnesium, Phosphorus

I am 18 years old or older.

My scans show possible spread or original squamous cell carcinoma.

Exclusion Criteria

Prior severe infusion reactions or hypersensitivity to other monoclonal antibody therapies

Pregnant (based on Screening serum or urine pregnancy test administered before infusions), or breastfeeding

Participants with known hypersensitivity to NOTA-ABY-030, cetuximab, murine, or any of the drug components used in this trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a loading dose of cetuximab followed by [18F]NOTA-ABY030, with PET/CT imaging performed at defined intervals to assess biodistribution and lesion uptake

1 day

Multiple visits for imaging within a single day

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 days

Long-term Follow-up

Participants are monitored for diagnostic performance and comparison with standard imaging modalities

36 months

What Are the Treatments Tested in This Trial?

Interventions

• 18F-NOTA-ABY-030
• Cetuximab

Trial Overview

The study tests a new PET imaging agent, [18F]NOTA-ABY030, combined with cetuximab in detecting cancer more accurately. It involves scanning at different times to see how well the agent shows tumor location compared to usual MRI, CT, or FDG-PET/CT scans.

How Is the Trial Designed?

Group I: Cohort 2 - (1 Whole Body PET/CT Scan) Experimental Treatment 3 Interventions

Cohort 2 will include 54 participants. Each participant will receive a 50 mg intravenous infusion of cetuximab, followed by a bolus injection of \[18F\]NOTA-ABY-030 at a dose of 5 (±1) mCi. Imaging for this cohort will be conducted at a single timepoint, approximately 0-240 minutes (±15 minutes) post-injection, based on optimized timing derived from Cohort 1 data. The PET/CT scan for Cohort 2 will cover the region from skull to chest, with a total scan time of approximately 30 minutes. This cohort is designed to evaluate the diagnostic performance of \[18F\]NOTA-ABY-030 in identifying indeterminate metastatic and/or primary lesions in head and neck squamous cell carcinoma (HNSCC), with a focus on sensitivity, specificity, and feasibility of the imaging protocol in a broader patient population.

Group II: Cohort 1 - Dosimetry (3 Whole Body PET/CT Scans) Experimental Treatment 3 Interventions

Cohort A will include a minimum of six participants up to 12 participants. These participants will receive a 50 mg intravenous infusion of cetuximab, followed by a bolus injection of \[18F\]NOTA-ABY-030 at a dose of 5 (±1) mCi. To evaluate tracer distribution and radiation exposure, participants in this cohort will undergo three whole-body PET/CT scans at specific timepoints: 0-90 minutes, 120 minutes, and 240 minutes post-injection. Each scan will cover the region from the skull to mid-thigh, with a total imaging time of approximately 90 minutes. This cohort is essential for determining the absorbed dose, organ-specific uptake, identification of critical organs, and the effective dose of the radiopharmaceutical. The data collected from Cohort A will inform safety parameters and support dose optimization for future clinical studies involving \[18F\]NOTA-ABY-030.

Who Is Running the Clinical Trial?

Vanderbilt-Ingram Cancer Center

Lead Sponsor

Trials

221

Recruited

64,400+

Citations

1.

ancora.ai

ancora.ai/it/detailsradiopharm/NCT07217028

Study Evaluating [18F]NOTA-ABY030 for Safety and ...

This Phase I clinical trial evaluates the safety, tolerability, and diagnostic performance of a novel PET imaging agent, [18F]NOTA-ABY030, ...

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withpower.com

withpower.com/trial/phase-1-squamous-cell-carcinoma-of-head-and-neck-10-2025-faa1b

PET Imaging Agent for Head and Neck Cancer

This Phase I clinical trial evaluates the safety, tolerability, and diagnostic performance of a novel PET imaging agent, \[18F\]NOTA-ABY030, ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3631810/

Role of 18F-FDG PET-CT in head and neck squamous cell ...

18 F-FDG PET-CT is particularly useful for staging, restaging and radiotherapy planning as well as for assessment of treatment response in HNSCC patients.

4.

cancernetwork.com

cancernetwork.com/view/-18f-aif-nota-pcp2-shows-pd-l1-monitoring-potential-in-head-and-neck-cancer

[18F]AIF-NOTA-PCP2 Shows PD-L1 Monitoring Potential in ...

AIF-NOTA-PCP2 may be a safe and effective PET tracer for noninvasive PD-L1 evaluation in patients with head and neck cancers, according to results from a ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38943453/

Efficacy of 18 FDG-PET/CT in Detecting Synchronous ...

The findings of this study suggest varied accuracy of 18 FDG-PET/CT in detecting SPMs during initial workup for HNSCC, highlighting the importance of screening ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07217028

NCT07217028 | Study Evaluating [18F]NOTA-ABY030 for ...

The data collected from Cohort A will inform safety parameters and support dose optimization for future clinical studies involving [18F]NOTA-ABY-030.

7.

linknovate.com

linknovate.com/clinical-trial/study-evaluating-18fnota-aby030-for-safety-and-tolerability-of-indeterminate-primary-andor-metastatic-disease-in-head-and-neck-squamous-cell-carcinoma-603058/

Study Evaluating [18F]NOTA-ABY030 for Safety and ...

The study aims to determine the agent's safety profile, calculate radiation dosimetry, and compare its sensitivity and specificity to conventional imaging ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4626365/

18F-Alfatide II PET/CT in healthy human volunteers and ...

18 F-Alfatide II is a safe PET tracer with a favorable dosimetry profile. The observed ED suggests that 18 F-Alfatide II is feasible for human studies.

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go.drugbank.com

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Advanced Filter

18F-NOTA-ABY-030 is a biologic drug. 18F-NOTA-ABY-030 is under investigation in clinical trial NCT07217028 (Study Evaluating [18F]NOTA-ABY030 for Safety and ...

10.

pubs.rsna.org

pubs.rsna.org/doi/full/10.1148/radiol.232209

Comparison of an Affibody-based Molecular Probe and 18 ...

The affibody-based tracer Al 18 F-NOTA-HER2-BCH enabled detection of more primary lesions and lymph node, bone, and liver metastases than fluorine 18 ...