PET-CT Scans for Head and Neck Cancer

Overseen By Stephen Breen, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must not be taking: Chemotherapy, EGFR inhibitors

Disqualifiers: Nasopharynx cancer, Distant metastases, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the usefulness of PET scans in planning and delivering radiation treatment for head and neck cancers. Participants will undergo a PET scan before and during their radiation treatment to help doctors target the cancer more precisely. The trial seeks individuals with mucosal squamous cell carcinoma of the head and neck who are receiving radiation therapy without prior chemotherapy or radiation. The PET scans will use a tracer called 18-F FDG (Fluorodeoxyglucose F 18) to highlight cancerous areas. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance cancer treatment planning and outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who have had chemotherapy or are taking certain cancer drugs. It's best to discuss your specific medications with the trial team.

What prior data suggests that PET-CT scans are safe for head and neck cancer patients?

Research has shown that 18-F FDG is generally safe for use in medical imaging, such as PET scans. Studies have found it effective and well-tolerated in patients with head and neck cancers. For instance, one study suggested that using PET-CT with 18-F FDG could safely help doctors identify the area for radiation treatment.

Another study examined safety details, including side effects, and found no major issues. While the studies did not report any significant negative effects, it is always important to follow healthcare professionals' advice when considering joining a trial. Overall, 18-F FDG has been used safely in medical scans, supporting its use in trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for head and neck cancer, such as surgery, radiation, and chemotherapy, the use of PET-CT scans with 18-F FDG is unique because it allows for precise imaging of cancerous tissues. This technique helps doctors see exactly where the cancer is and how it's behaving, which can lead to more accurate treatment plans. Researchers are excited about this approach because it could improve how effectively radiation therapy is targeted, potentially leading to better outcomes and fewer side effects for patients.

What evidence suggests that PET-CT scans are effective for planning radiation treatment in head and neck cancer?

Research has shown that an 18-F FDG PET scan is helpful in treating head and neck cancer. In this trial, patients with head and neck squamous cell carcinoma (HNSCC) receiving radiation therapy (RT) will undergo 18-F FDG PET scans. These scans provide detailed images of the cancer, aiding doctors in planning radiation treatments more accurately. One study found that patients who had regular 18-F FDG PET scans lived longer over three years. These scans are also effective for diagnosing and monitoring head and neck cancers, leading to better treatment outcomes. In short, 18-F FDG PET scans can enhance the treatment and monitoring of these cancers. ^{1 3 6 7 8}

Who Is on the Research Team?

John J Kim, MD

Principal Investigator

The Princess Margaret Cancer Foundation

Are You a Good Fit for This Trial?

This trial is for adults with non-nasopharynx head and neck cancers who haven't had chemotherapy or radiotherapy in the last 5 years. They should have visible cancer that's treatable with radiation alone, and a tumor that shows up on PET scans. Pregnant individuals or those unable to consent are excluded.

Inclusion Criteria

Radiologically evident gross disease

My cancer is a type of squamous cell not in the nasopharynx area.

My tumor showed high activity on the initial PET-CT scan.

Exclusion Criteria

I cannot lie on my back for an extended period.

Inability to provide informed consent

I have had radiotherapy for head or neck cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment PET Scan

Participants undergo a PET scan before starting radiation treatment to assist in planning

1 week

1 visit (in-person)

Radiation Treatment

Participants receive radiation treatment with PET scans conducted during the treatment

6-8 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment as per standard practice

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 18-F FDG

Trial Overview The study is testing how helpful PET scans are before and during radiation treatment for head and neck cancer patients. It aims to improve treatment planning by using additional PET scan data alongside routine tests.

How Is the Trial Designed?

Group I: HNSCC Patients receiving RT Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

18F-FDG PET/CT is a valuable tool in managing head and neck cancers, aiding in staging, treatment planning, and monitoring response to therapy.

The newer 18F-FDG PET/MR imaging combines the detailed soft tissue imaging of MRI with the functional insights from PET, enhancing the overall assessment of head and neck tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET Imaging for Head and Neck Cancers. Marcus, C., Sheikhbahaei, S., Shivamurthy, VKN., et al.[2021]

In a study of 92 head and neck squamous cell carcinoma (HNSCC) patients, higher levels of the lipid metabolism marker CD36 in primary lesions were associated with false-negative results in 18FDG-PET/CT scans for lymph node metastasis.

The findings suggest that measuring CD36 expression could help identify patients at risk for false-negative PET/CT results, potentially improving the accuracy of lymph node metastasis detection in HNSCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lipid metabolism marker CD36 is associated with 18FDG-PET/CT false negative lymph nodes in head and neck squamous cell carcinoma. Meng, X., Sun, J., Xu, F., et al.[2023]

In a study of 158 patients with head and neck squamous cell carcinoma (HNSCC), 67% of recurrences or second primary cancers were detected by (18) F-FDG PET/CT scans, highlighting its effectiveness in posttreatment surveillance.

Patients who had their first PET/CT scan within 4 months after treatment showed significantly better disease-specific and overall survival compared to those who had scans later, suggesting that early detection can improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of subclinical recurrence or second primary cancer using (18) F-FDG PET/CT in patients treated curatively for head and neck squamous cell carcinoma. Kikuchi, M., Shinohara, S., Hino, M., et al.[2018]

The combination of FDG-PET and CT imaging provides detailed anatomical and physiological information for staging head and neck cancers, which can reveal unexpected distant metastases that may change treatment plans.

PET-CT imaging enhances the precision of target volume delineation in radiotherapy, potentially improving local control of the cancer while minimizing damage to surrounding healthy tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of PET-CT fusion in head and neck cancer. Rusthoven, KE., Koshy, M., Paulino, AC.[2016]

FDG-PET demonstrated a high sensitivity of 96% for detecting lymph node metastases in patients with primary head and neck cancer, outperforming CT and ultrasonography with fine-needle aspiration cytology (US/FNAC).

The use of FDG-PET also revealed second primary tumors in 17% of patients, highlighting its importance in comprehensive cancer assessment and suggesting it should be routinely used in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative evaluation of patients with primary head and neck cancer using dual-head 18fluorodeoxyglucose positron emission tomography. Stokkel, MP., ten Broek, FW., Hordijk, GJ., et al.[2019]

Positron emission tomography (PET) is essential for staging head and neck cancer, with (18)F-fluoro-2-deoxy-D-glucose (FDG) being the most commonly used tracer.

This review highlights alternative PET tracers that can visualize different metabolic processes, potentially overcoming the limitations associated with FDG PET in identifying head and neck cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternative PET tracers in head and neck cancer. A review. Wedman, J., Pruim, J., Roodenburg, JL., et al.[2021]

In a study of 45 patients with head and neck tumors, F-18-FDG PET scans demonstrated a high sensitivity of 97% for detecting tumors, significantly outperforming CT scans which had a sensitivity of only 80%.

PET scans also showed an 82% specificity for identifying benign processes, making it a valuable tool for distinguishing between recurrent tumors and treatment-related changes, potentially improving patient management and reducing healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Utility of FDG-PET in Detecting Head and Neck Tumors. A Comparison of Diagnostic Methods and Modalities. Hubner, KF., Thie, JA., Smith, GT., et al.[2020]

PET/CT imaging is highly sensitive for staging squamous carcinoma of the head and neck, but its effectiveness is limited by tumor size and cannot fully replace elective neck dissection for assessing cervical metastases.

In posttreatment monitoring, PET/CT can identify persistent cancer in about two-thirds of cases before clinical observation, but its cost-effectiveness and impact on treatment outcomes remain unclear, especially for patients with glandular tumors or low-volume tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET/CT in head and neck oncology: State-of-the-art 2013. Johnson, JT., Branstetter, BF.[2022]

Fluorine-labeled deoxyglucose (FDG) PET scanning is as reliable as conventional imaging methods for identifying primary and metastatic tumors in head and neck cancer, with better performance in detecting nodal metastases compared to small primary tumors.

In patients who have undergone radiation therapy, FDG-PET is significantly more effective than clinical examination and conventional imaging in distinguishing between tumor recurrence and soft-tissue changes due to radiation, highlighting its importance in post-treatment evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET scanning in head and neck oncology: a review. McGuirt, WF., Greven, K., Williams, D., et al.[2019]

In a study involving 30 patients with head and neck squamous cell carcinoma, (18)F-FDG uptake measurements from both PET/CT and PET/MR scans showed high reproducibility, with mean differences of about 4% for PET/CT and 3% for PET/MR.

There was no significant difference in the reproducibility of (18)F-FDG uptake between PET/CT and PET/MR, indicating that both imaging modalities can be reliably used for assessing metabolic tumor activity in HNSCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reproducibility of (18)F-FDG PET uptake measurements in head and neck squamous cell carcinoma on both PET/CT and PET/MR. Rasmussen, JH., Fischer, BM., Aznar, MC., et al.[2018]

In a study of 21 patients with cervical lymph node metastases, the use of fused FDG-PET/CT images identified primary tumors in 57% of cases, demonstrating improved sensitivity compared to CT alone, which only identified 23%.

The findings suggest that while FDG-PET/CT enhances tumor detection compared to CT alone, it does not significantly outperform FDG-PET alone or when FDG-PET and CT are read side by side, indicating its value in the clinical evaluation of unknown primary tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual modality of 18F-fluorodeoxyglucose-positron emission tomography/computed tomography in patients with cervical carcinoma of unknown primary. Freudenberg, LS., Fischer, M., Antoch, G., et al.[2016]

In a study of 27 patients with head and neck cancers, 18F-FDG PET-CT imaging effectively identified primary tumors and confirmed metastases, showing positive results in all pre-radiation nasopharyngeal carcinoma (NPC) cases and accurately detecting recurrences in post-radiation patients.

The imaging technique proved valuable in diagnosing unknown primary tumors in neck metastatic patients, with a high confirmation rate of findings through histopathological analysis, highlighting its efficacy in managing head and neck cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical evaluation of 18-fluorine fluorodeoxyglucose positron emission tomography-CT imaging in head and neck tumors]. Li, XP., Liang, Y., Liu, X., et al.[2016]

In a study of 121 patients with head and neck squamous cell carcinoma, the use of (18) F-FDG PET/CT did not significantly improve disease-specific survival (DSS) or overall survival (OS) for those treated with radiochemotherapy alone.

However, for patients undergoing a combined treatment of surgery and radiochemotherapy, the addition of (18) F-FDG PET/CT was associated with improved outcomes, likely due to better tumor localization for surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved treatment outcomes with (18) F-FDG PET/CT for patients with advanced head and neck squamous cell carcinoma. Haerle, SK., Soyka, MB., Schmid, DT., et al.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9945665/

[18F]FDG PET/CT in head and neck squamous cell ... The study's aim is a head-to-head comparison between the diagnostic performance of the Hopkins criteria, the Deauville score, and the new proposed Cuneo score.

2. jnm.snmjournals.org jnm.snmjournals.org/content/65/10/1533

Diagnostic Accuracy of [18F]FDG PET/MRI in Head and Neck ... This study evaluates the diagnostic utility of PET/MRI for primary, locoregional, and nodal head and neck squamous cell carcinoma (HNSCC) through systematic ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2807804

An Intensive 18 F-Fludeoxyglucose–Positron Emission ... This case-control study found that use of 18 FDG-PET/CT in the standard annual CFU of HNSCC was associated with a 3-year survival benefit.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12162685/

3-year overall survival benefit of systematic follow-up with ... The aim was to assess the potential benefit of a systematic post-treatment follow-up strategy using 18 F-FDG PET/CT imaging on overall survival.

5. mdpi.com mdpi.com/2072-6694/16/10/1905

Role of 18F-FDG PET/CT in Head and Neck Squamous ... This article provides an overview of the use of 18F-FDG PET/CT in various clinical scenarios of head–neck squamous cell carcinoma, ranging from initial ...

6. ejhi.springeropen.com ejhi.springeropen.com/articles/10.1186/s41824-024-00197-6

Efficacy and safety of FDG-PET for determining target volume ... The results suggest that the target volume determined by PET-CT could safely reduce GTV size and interobserver variability in patients with locally advanced ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5124833/

Role of fluorine-18 fluorodeoxyglucose PET/CT in head ... However, 18F-FDG-PET, even visually correlated with CT/MRI, was unable to reduce the rate of false negative to <20% in patients with T4 tumour (neck treatment ...

8. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/251095

Can [18F]FDG-PET/CT Predict PD-L1 Expression in Head ... Safety, including monitoring of adverse events and vital signs, biodistribution, and imaging correlations with PD-L1 expression were analyzed.