Investigational Scan for Head and Neck Cancer

Overseen By Amol M. Takalkar, MD, MS, MBA, FACNM

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Emory University

Must not be taking: Immunotherapy agents

Disqualifiers: Pregnancy, Prisoners, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: 2

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for scanning blood vessels in the neck for patients with head and neck cancer undergoing radiation therapy. It compares a new imaging technique using sodium fluoride F-18, a type of contrast agent, with the usual method to determine which better reveals changes in blood vessels. F-18 NaF PET/CT scans may provide clearer images of radiation's effects on blood vessels. Individuals with squamous cell carcinoma in areas like the throat who are receiving chemoradiotherapy may be suitable for this trial. As an Early Phase 1 trial, this research aims to understand how this new imaging method functions in people, offering participants the chance to contribute to groundbreaking advancements in cancer imaging.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you have had chemotherapy or radiotherapy within 4 weeks before the study or if you are receiving any investigational agents or devices within 21 days before the study imaging.

What prior data suggests that this imaging technique is safe for assessing head and neck cancer?

Research has shown that sodium fluoride F-18, used in PET/CT scans, can aid imaging. However, some studies have identified safety concerns. Sodium fluoride F-18 may increase cancer risk, so using the smallest dose possible is crucial. Careful handling of the treatment ensures patient safety. Although previously used for imaging bones and joints, weighing the benefits against the risks remains important. These findings should be considered when deciding to join a clinical trial involving this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Sodium Fluoride F-18 in head and neck cancer diagnostics because it offers a new way to assess bone metabolism and potential cancer spread. Unlike the standard F-18 FDG PET/CT scans that focus on glucose metabolism, F-18 NaF PET/CT provides detailed images of bone activity, which can be crucial for detecting cancer metastasis to the bones. This approach could lead to earlier and more accurate detection, potentially improving treatment outcomes for patients with head and neck cancer.

What evidence suggests that this investigational scan is effective for assessing radiation effects on blood vessels in head and neck cancer?

This trial will evaluate the effectiveness of Sodium Fluoride F-18 (F-18 NaF) PET/CT scans in detecting bone problems and changes caused by cancer in the head and neck. Participants in Arm I will undergo F-18 NaF PET/CT scans with standard-of-care (SOC) intensity-modulated radiation therapy (IMRT), while those in Arm II will have the scans with SOC intensity-modulated proton therapy (IMPT). Research has shown that F-18 NaF PET/CT scans can match or surpass standard F-18 FDG PET/CT scans in assessing how radiation therapy affects neck blood vessels. This is crucial because radiation treatment for head and neck cancers can alter blood flow to the brain. The F-18 NaF PET/CT scan provides clear images that help doctors understand these changes better. Early results suggest that this method might more accurately identify both the presence and absence of issues compared to other scans. ^{3 4 6 7 8}

Who Is on the Research Team?

Amol M Takalkar, MD, MS, MBA, FACNM

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for patients with various types of head and neck cancers who are receiving radiation therapy. It's designed to see if a new type of PET/CT scan using F-18 NaF can better assess the impact of radiation on neck blood vessels compared to the standard F-18 FDG PET/CT scan.

Inclusion Criteria

Patients must give protocol-specific consent on an Institutional Review Board (IRB)-approved consent form prior to completion of protocol-specific testing/procedures

I have advanced throat cancer that is not caused by HPV, or I have early to mid-stage HPV-related throat cancer and am receiving non-surgical treatment.

I am receiving or will receive chemotherapy and radiation as per my hospital's guidelines.

Exclusion Criteria

History of allergic reactions attributed to compounds of similar chemical or biological composition to F-18 NaF or other agents used in the study

Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of the F-18 NaF for the pre-RT PET/CT imaging

Pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Participants receive F-18 NaF IV and undergo PET/CT within 28 days of each SOC F-18 FDG PET/CT on study, once prior to initiation of SOC IMRT or IMPT

4 weeks

1 visit (in-person)

Radiation Therapy

Participants undergo SOC intensity-modulated radiation therapy (IMRT) or intensity-modulated proton therapy (IMPT)

12 weeks

Follow-up Imaging

Participants receive F-18 NaF IV and undergo PET/CT 12 weeks after completion of SOC IMRT or IMPT

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-5 days

What Are the Treatments Tested in This Trial?

Interventions

• Sodium Fluoride F-18

Trial Overview The study is testing whether an investigational imaging technique (F-18 NaF PET/CT) is as effective or more so than the current standard (F-18 FDG PET/CT) in evaluating vascular complications from radiation therapy in head and neck cancer patients.

How Is the Trial Designed?

Group I: Arm II (F-18 NaF PET/CT) Experimental Treatment 5 Interventions

Patients receive F-18 NaF IV and undergo PET/CT within 28 days of each SOC F-18 FDG PET/CT on study, once prior to initiation of SOC IMPT and once 12 weeks after completion of SOC IMPT.

Group II: Arm I (F-18 NaF PET/CT) Experimental Treatment 5 Interventions

Patients receive F-18 NaF IV and undergo PET/CT within 28 days of each SOC F-18 FDG PET/CT on study, once prior to initiation of SOC IMRT and once 12 weeks after completion of SOC IMRT.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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 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]

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]

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]

Citations

1. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/rg.345130061

Role of 18 F-NaF Skeletal PET/CT in Oncologic Practice Growing evidence suggests that 18 F-NaF PET/CT provides increased sensitivity and specificity in the detection of bone metastases.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4258001/

Sodium 18F-Fluoride PET/CT of Bone, Joint and Other ... In this section, we briefly review the major reports on the utility of 18F-NaF PET or PET/CT in various cancers. Head and Neck Cancer. In an investigation of 80 ...

3. jnm.snmjournals.org jnm.snmjournals.org/content/53/11/1730

Utility of 18F-Fluoride PET/CT and 18F-FDG PET/CT in the ... 18 F-fluoride PET/CT is a feasible modality for detecting bony metastases in patients with head and neck cancers, with similar sensitivity to 18 F-FDG PET/CT.

4. cancer.gov cancer.gov/clinicaltrials/NCI-2025-00404

Comparing an Investigational Scan (F-18 NaF PET/CT) to ... Imaging with F-18 NaF PET/CT may be as effective or more effective than the standard F-18 FDG PET/CT for assessing the effects radiation therapy has on blood ...

5. cms.gov cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id233_mccarthy_comment.pdf

Review of Published Literature on the Use of Sodium ... This is a review of the recent published literature reporting efficacy and safety of sodium fluoride F 18 (18F-NaF) positron emission tomography (PET) for the ...

6. dctd.cancer.gov dctd.cancer.gov/drug-discovery-development/reagents-materials/imaging-ind-resources/documentation/naf-ib.pdf

sodium fluoride f 18 injection investigator's brochure Studies have shown sodium fluoride F 18 (18F-NaF) PET and 18F-NaF. PET/computerized axial tomography (CT) to be superior to conventional methods, such as whole- ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2011/022494orig1s000lbl.pdf

022494Orig1s000 - accessdata.fda.gov Cancer Risk: Sodium Fluoride F 18 Injection may increase the risk of cancer. Use the smallest dose necessary for imaging and ensure safe ...

8. siemens-healthineers.com siemens-healthineers.com/en-us/molecular-imaging/petnet-solutions-mibr/sodium-fluoride-f18-injection

Sodium Fluoride F 18 Injection Sodium fluoride F18 injection may increase the risk of cancer. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and ...