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

Trial Summary

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 data supports the effectiveness of the treatment Sodium Fluoride F-18 for head and neck cancer?

The research does not provide direct evidence on the effectiveness of Sodium Fluoride F-18 for head and neck cancer, but it does compare similar imaging techniques like 18F-FDG PET/CT, which are used to detect cancer spread and improve treatment outcomes. ^{1 2 3 4 5}

Is Sodium Fluoride F-18 safe for use in humans?

The research articles provided do not contain specific safety data for Sodium Fluoride F-18 in humans. ^{1 3 6 7 8}

How does the investigational scan for head and neck cancer differ from other treatments?

This investigational scan uses a new PET tracer called 18F-EF5 to image hypoxia (low oxygen areas) in head and neck cancer, which is different from the standard 18F-FDG PET/CT scans. It provides additional information about radioresistant tumor hypoxia, potentially helping in targeting these areas during treatment planning. ^{6 9 10 11 12}

What is the purpose of this trial?

This early phase I trial compares sodium fluoride F-18 (F-18 NaF) positron emission tomography (PET)/computed tomography (CT) to the standard of care imaging scan (and fludeoxyglucose F-18 \[F-18 FDG\] PET/CT) for assessing the effects radiation therapy has on the blood vessels in the neck in patients with head and neck cancers. For people with cancers in the head and neck, doctors often use radiation to target both the tumor and nearby glands. Radiation therapy to this region can affect the blood vessels in the neck that supply blood to the brain. F-18 NaF and F-18 FDG are contrast agents that can be used together with PET/CT imaging to visualize areas inside the body. A PET scan is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. A CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional views of tissues and organs. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination. 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 vessels in the neck in patients with head and neck cancers.

Research Team

Amol M Takalkar, MD, MS, MBA, FACNM

Principal Investigator

Emory University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. England 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. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Comparison of 18F-FDG PET/CT scan and 99mTc-MDP bone scintigraphy in detecting bone metastasis in head and neck tumors. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Utility of 18F-fluoride PET/CT and 18F-FDG PET/CT in the detection of bony metastases in heightened-risk head and neck cancer patients. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Improved treatment outcomes with (18) F-FDG PET/CT for patients with advanced head and neck squamous cell carcinoma. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Use of 18F-FDG PET/CT as a predictive biomarker of outcome in patients with head-and-neck non-squamous cell carcinoma. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

PET Imaging for Head and Neck Cancers. [2021]

7. United States 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. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Does 18fluoro-fluorodeoxyglucose positron emission tomography improve recurrence detection in patients treated for head and neck squamous cell carcinoma with negative clinical follow-up? [2016]

9. United States pubmed.ncbi.nlm.nih.gov

18F-EF5: a new PET tracer for imaging hypoxia in head and neck cancer. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Comparison of thallium-201 and F-18 FDG SPECT uptake in squamous cell carcinoma of the head and neck. [2021]

11. England pubmed.ncbi.nlm.nih.gov

The value of fluorine-18 fluorodeoxyglucose PET/MRI in the diagnosis of head and neck carcinoma: a meta-analysis. [2016]

12. United States pubmed.ncbi.nlm.nih.gov

Role of Non-FDG-PET/CT in Head and Neck Cancer. [2021]