Fluciclovine F18 PET/CT in Identifying the Origin of Head and Neck Squamous Cell Carcinoma in Patients With Metastatic Cervical Nodal Disease
NCT ID: NCT03868020
Last Updated: 2024-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
16 participants
INTERVENTIONAL
2019-04-24
2024-03-22
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (fluciclovine F18 PET/CT)
Patients receive fluciclovine F18 IV and undergo PET/CT scan over 20-30 minutes.
Computed Tomography
Undergo PET/CT
Fluciclovine F18
Given IV
Positron Emission Tomography
Undergo PET/CT
Interventions
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Computed Tomography
Undergo PET/CT
Fluciclovine F18
Given IV
Positron Emission Tomography
Undergo PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Maria K Gule-Monroe
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2019-00597
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-0898
Identifier Type: OTHER
Identifier Source: secondary_id
2018-0898
Identifier Type: -
Identifier Source: org_study_id
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