Standard and Delayed FDG PET/CT After Chemoradiation Therapy in Assessing Patients With Metastatic Head and Neck Squamous Cell Cancer

Metastatic Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

Dual-Time Point (DTP) FDG PET CT for the Post-Treatment Assessment of Head and Neck Tumors Following Definitive Chemoradiation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03575949
• Other study ID #: 2017-0826
• Secondary ID: NCI-2018-0264020
• Status: Completed
• Phase: N/A
• Start date: June 15, 2018
• Est. completion date: May 10, 2024

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial studies how well standard and delayed fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) given after standard radiation and chemotherapy works in assessing patients with head and neck squamous cell cancer that has spread to other places in the body. Diagnostic procedures, such as PET/CT, use radioactive material, such as fludeoxyglucose F-18, to find and diagnose head and neck tumors and may help to find out how far the disease has spread.

Description:

PRIMARY OBJECTIVE:

I. To assess the optimal imaging time using FDG positron emission tomography (PET) with comparison between a standard of care 1-hour scan (early) and the research scan of 3-hours scan (delayed) post radiotracer administration that maximizes separation of activity between lesion and non-lesional parenchyma (measured as lesion/background [L/B] ratio) in patients with head and neck primary squamous cell carcinoma following chemoradiation treatment.

OUTLINE:

Patients receive fludeoxyglucose F-18 intravenously (IV) over 1 minute and undergo PET/CT at 70 and 180 minutes after injection at 12-14 weeks following standard chemoradiation (CRT) completion.

After completion of study, patients are followed up at 30 days and then periodically for up to 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 10, 2024
• Est. primary completion date: May 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult with computed tomography (CT) or fludeoxyglucose F-18 (FDG) positron emission tomography (PET) findings of cervical nodal metastasis from a head and neck primary squamous cell carcinoma treated with definitive chemoradiation

Exclusion Criteria:

• Children

• No evidence of cervical nodal metastasis

• Active infection of the head and neck

• Known allergy to FDG, iodine or gadolinium-based contrast agents

• Blood glucose (> 250 mg/dl)

• Pregnant women

Related Conditions & MeSH terms

• Metastatic Head and Neck Squamous Cell Carcinoma
• Metastatic Malignant Neoplasm in the Spine
• Neoplasms
• Squamous Cell Carcinoma of Head and Neck

Intervention

Procedure:
• Computed Tomography
Undergo FDG PET/CT

Other:
• Fludeoxyglucose F-18
Given IV

Procedure:
• Positron Emission Tomography
Undergo FDG PET/CT

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optimal imaging time	Determined by fludeoxyglucose F-18 (FDG) positron emission tomography. The optimal time point is defined as the time point that meets the following requirements: 1) it has the largest average lesion/background (L/B) ratio, and 2) if the delayed time point is greater, it must be significantly different from the initial time point at the 0.025 significance level. The acquired PET data will be reconstructed using iterative techniques with resolution recovery. All delayed time points will then be registered using rigid techniques to the standard of care initial PET/CT image. Volumes of interest around the largest nodal metastasis will be drawn and the standard uptake value (SUV) max will be calculated. A corresponding region for largest nodal metastasis will be drawn on the contralateral sternocleidomastoid muscle respective to each lesion to determine L/B ratio, where L is the lesion SUV max and B is the corresponding background SUV max.	Up to 6 months
Primary	Differences in L/B ratio	Differences in L/B ratio between the initial and delayed time point will be tested via paired t-test after appropriate transformation.	Up to 6 months

External Links

•   MD Anderson Cancer Center