Fluciclovine F18 PET/CT in Identifying the Origin of Head and Neck Squamous Cell Carcinoma in Patients With Metastatic Cervical Nodal Disease

Metastatic Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

Pilot Study of 18F Fluciclovine PET CT in Identification of the Primary in Patients With an Unknown Primary Head and Neck Squamous Cell Carcinoma Presenting With Metastatic Cervical Nodal Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03868020
• Other study ID #: 2018-0898
• Secondary ID: NCI-2019-0059720
• Status: Completed
• Phase: Early Phase 1
• Start date: April 24, 2019
• Est. completion date: March 22, 2024

Study information

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

Clinical Trial Summary

This early phase I trial studies how well fluciclovine F18 positron emission tomography (PET)/computed tomography (CT) works in identifying the origin of head and neck squamous cell carcinoma in patients with cancer that has spread to the cervical lymph nodes. Fluciclovine F18 during a PET/CT scan may work better in helping doctors learn where the cancer started (called the site of origin) and directing treatment planning compared to standard fludeoxyglucose F-18 (FDG) PET-CT scans.

Description:

PRIMARY OBJECTIVES:

I. To estimate positive predictive value with a corresponding 95% confidence interval for fluciclovine F18 (18F fluciclovine) positron emission tomography computed tomography (PET CT) to detect a primary site of disease in patients presenting with cervical metastatic nodal disease but a head and neck primary site not apparent on CT of the neck with contrast (contrast enhanced-computed tomography, CE-CT).

SECONDARY OBJECTIVES:

I. To estimate positive predictive value with a corresponding 95% confidence interval for fludeoxyglucose F-18 (18F FDG) PET CT in the detection of a primary site of disease in patients presenting with cervical metastatic nodal disease but a head and neck primary site not apparent on CT of the neck with contrast.

EXPLORATORY OBJECTIVES:

I. To compare the lesion to background (L/B) ratios for nodal metastatic disease between 18F fluciclovine PET CT and 18F FDG PET CT.

II. To estimate the sensitivity of 18F fluciclovine PET CT and 18F FDG PET CT to detect nodal disease.

III. To evaluate for any trends in findings on 18F fluciclovine PET CT and human papillomavirus (HPV) status.

OUTLINE:

Patients receive fluciclovine F18 intravenously (IV) and undergo PET/CT scan over 20-30 minutes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 22, 2024
• Est. primary completion date: March 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults with biopsy proven metastatic cervical nodal squamous cell carcinoma

• CT of the neck with contrast that does not confidently identify a primary oropharyngeal site of disease

• Planned standard of care 18F-FDG PET CT examination

• Planned standard of care exam under anesthesia with oropharyngeal surgical biopsy

Exclusion Criteria:

• Pregnant women

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

• Severe renal dysfunction (glomerular filtrate rate [within 30 days] less than 30)

• Inability to tolerate lying supine, relatively motionless for up to 1 hour

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Metastatic Head and Neck Squamous Cell Carcinoma
• Metastatic Squamous Cell Carcinoma in Cervical Lymph Node
• Squamous Cell Carcinoma of Head and Neck

Intervention

Procedure:
• Computed Tomography
Undergo PET/CT

Radiation:
• Fluciclovine F18
Given IV

Procedure:
• Positron Emission Tomography
Undergo 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
Other	Lesion to background (L/B) ratios for nodal metastatic disease	L/B ratios for nodal metastatic disease will be compared between fluciclovine F18 (18F-flucivlovine) positron emission tomography computed tomography (PET CT) and fludeoxyglucose F-18 (18F FDG) PET CT. For lesions that are identified by both 18F FDG PET CT and 18F fluciclovine PET CT, paired t-tests will be used to compare the L/B ratios for primary sites. This analysis will be repeated for nodal metastatic disease sites that are identified by both methods.	Up to 2 years
Other	Sensitivity and specificity in detecting nodal disease	For nodes that are biopsied, pathology will serve as the gold standard, and the sensitivity and specificity will be estimated separately for 18F FDG PET CT and for 18F fluciclovine PET CT. For nodes that are not, 18F FDG PET CT will serve as the gold standard, and the sensitivity and specificity of 18F-flucivlovine PET CT will be estimated.	Up to 2 years
Primary	Proportion of the suspected lesions that are positive by the gold standard of pathology	Positive predicative values will be estimated with a corresponding exact 95% confidence interval.	Up to 2 years

External Links

•   MD Anderson Cancer Center Website