Fluciclovine F18 PET/CT in Identifying the Origin of Head and Neck Squamous Cell Carcinoma in Patients With Metastatic Cervical Nodal Disease
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|ClinicalTrials.gov Identifier: NCT03868020|
Recruitment Status : Not yet recruiting
First Posted : March 8, 2019
Last Update Posted : March 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Head and Neck Squamous Cell Carcinoma Metastatic Squamous Cell Carcinoma in Cervical Lymph Node||Procedure: Computed Tomography Radiation: Fluciclovine F18 Procedure: Positron Emission Tomography||Early Phase 1|
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).
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.
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.
Patients receive fluciclovine F18 intravenously (IV) and undergo PET/CT scan over 20-30 minutes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||July 30, 2019|
|Estimated Primary Completion Date :||August 31, 2021|
|Estimated Study Completion Date :||August 31, 2021|
Experimental: Diagnostic (fluciclovine F18 PET/CT)
Patients receive fluciclovine F18 IV and undergo PET/CT scan over 20-30 minutes.
Procedure: Computed Tomography
Radiation: Fluciclovine F18
Procedure: Positron Emission Tomography
- Proportion of the suspected lesions that are positive by the gold standard of pathology [ Time Frame: Up to 2 years ]Positive predicative values will be estimated with a corresponding exact 95% confidence interval.
- Lesion to background (L/B) ratios for nodal metastatic disease [ Time Frame: Up to 2 years ]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.
- Sensitivity and specificity in detecting nodal disease [ Time Frame: Up to 2 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868020
|Contact: Maria K Gule-Monroeemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Not yet recruiting|
|Houston, Texas, United States, 77030|
|Contact: Maria K. Gule-Monroe 281-546-7750|
|Principal Investigator: Maria K. Gule-Monroe|
|Principal Investigator:||Maria K Gule-Monroe||M.D. Anderson Cancer Center|