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

Early Phase 1

Completed

• Conditions: Metastatic Squamous Cell Carcinoma in Cervical Lymph Node; Metastatic Head and Neck Squamous Cell Carcinoma
• Interventions: Procedure: Computed Tomography; Radiation: Fluciclovine F18; Procedure: Positron Emission Tomography

• Registration Number: NCT03868020
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-03-07
• Study First Submitted QC: 2019-03-07
• Study First Posted: 2019-03-08
• Study Start: 2019-04-24
• Status Verified: 2024-03
• Primary Completion: 2024-03-22
• Study Completion: 2024-03-22
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (fluciclovine F18 PET/CT)	Fluciclovine F18	Patients receive fluciclovine F18 IV and undergo PET/CT scan over 20-30 minutes.
Diagnostic (fluciclovine F18 PET/CT)	Computed Tomography	Patients receive fluciclovine F18 IV and undergo PET/CT scan over 20-30 minutes.
Diagnostic (fluciclovine F18 PET/CT)	Positron Emission Tomography	Patients receive fluciclovine F18 IV and undergo PET/CT scan over 20-30 minutes.

Primary Outcome Measures

Name	Time	Method
Proportion of the suspected lesions that are positive by the gold standard of pathology	Up to 2 years	Positive predicative values will be estimated with a corresponding exact 95% confidence interval.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States