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

M.D. Anderson Cancer Center

Status and phase: Completed; Early Phase 1

Conditions: Metastatic Squamous Cell Carcinoma in Cervical Lymph Node; Metastatic Head and Neck Squamous Cell Carcinoma

Treatments: Procedure: Positron Emission Tomography; Procedure: Computed Tomography; Radiation: Fluciclovine F18

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03868020

P30CA016672 (U.S. NIH Grant/Contract)

2018-0898 (Other Identifier)

NCI-2019-00597 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Diagnostic (fluciclovine F18 PET/CT)

Experimental group

Description:

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

Treatment:

Radiation: Fluciclovine F18

Procedure: Computed Tomography

Procedure: Positron Emission Tomography