Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT03868020
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2019-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fluciclovine F18 PET/CT in Identifying the Origin of Head and Neck Squamous Cell Carcinoma in Patients With Metastatic Cervical Nodal Disease
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2019-00597 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 2018-0898 | OTHER | M D Anderson Cancer Center | View | |
| P30CA016672 | NIH | None | https://reporter.nih.gov/quic… | View |