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

March 26, 2024 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (fluciclovine F18 PET/CT)
Patients receive fluciclovine F18 IV and undergo PET/CT scan over 20-30 minutes.
Procedure: Computed Tomography
Undergo PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • tomography
  • computerized tomography
  • CT SCAN
Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
Radiation: Fluciclovine F18
Given IV
Other Names:
  • (18F)Fluciclovine
  • (18F)GE-148
  • 18F-Fluciclovine
  • [18F]FACBC
  • Anti-(18f)FABC
  • Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid
  • Anti-[18F] FACBC
  • Axumin
  • Fluciclovine (18F)
  • FLUCICLOVINE F-18
  • GE-148 (18F)
  • GE-148 F-18

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 2 years
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.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Maria K Gule-Monroe, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2019

Primary Completion (Actual)

March 22, 2024

Study Completion (Actual)

March 22, 2024

Study Registration Dates

First Submitted

March 7, 2019

First Submitted That Met QC Criteria

March 7, 2019

First Posted (Actual)

March 8, 2019

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-0898 (Other Identifier: M D Anderson Cancer Center)
  • P30CA016672 (U.S. NIH Grant/Contract)
  • NCI-2019-00597 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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