Metastatic Head and Neck Squamous Cell CarcinomaEarly Phase 1NCT03868020
Fluciclovine F18 PET/CT in Identifying the Origin of Head and Neck Squamous Cell Carcinoma in Patients With Metastatic Cervical Nodal Disease
A Early Phase 1 study testing Computed Tomography, Fluciclovine F18 and Positron Emission Tomography in people with Metastatic Head and Neck Squamous Cell Carcinoma and Metastatic Squamous Cell Carcinoma in Cervical Lymph Node, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Squamous Cell Carcinoma in Cervical Lymph Node
- What is being tested?
- Computed Tomography, Fluciclovine F18 and Positron Emission Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2019to 22 Mar 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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:
- 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
- Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Squamous Cell Carcinoma in Cervical Lymph Node
- Being tested
- Computed Tomography, Fluciclovine F18, Positron Emission Tomography
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, computerized tomography
Undergo PET/CT
Fluciclovine F18Radiation
Also called (18F)Fluciclovine, (18F)GE-148, 18F-Fluciclovine, [18F]FACBC
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (fluciclovine F18 PET/CT) | Experimental | Patients receive fluciclovine F18 IV and undergo PET/CT scan over 20-30 minutes. Receives: Procedure: Computed Tomography; Radiation: Fluciclovine F18; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of the suspected lesions that are positive by the gold standard of pathology
Positive predicative values will be estimated with a corresponding exact 95% confidence interval.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start24 Apr 2019
- Primary completion22 Mar 2024
- Study completion22 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Maria K Gule-Monroe, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868020
- Sponsor's protocol ID
- 2018-0898
- Other IDs
- NCI-2019-00597, 2018-0898, P30CA016672
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2019
- Last updated
- 28 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03868020
- Acronym / sponsor ID
- 2018-0898
- Conditions
- Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Squamous Cell Carcinoma in Cervical Lymph Node
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 8 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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:
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (fluciclovine F18 PET/CT) | Experimental | Procedure: Computed Tomography, Radiation: Fluciclovine F18, Procedure: Positron Emission TomographyPatients receive fluciclovine F18 IV and undergo PET/CT scan over 20-30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, computerized tomographyUndergo PET/CT | Procedure or surgery | Diagnostic (fluciclovine F18 PET/CT) |
| Fluciclovine F18Also: (18F)Fluciclovine, (18F)GE-148, 18F-Fluciclovine, [18F]FACBCGiven IV | Radiation | Diagnostic (fluciclovine F18 PET/CT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo PET/CT | Procedure or surgery | Diagnostic (fluciclovine F18 PET/CT) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria K Gule-Monroe principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Computed Tomography, Fluciclovine F18 and Positron Emission Tomography in people with Metastatic Head and Neck Squamous Cell Carcinoma and Metastatic Squamous Cell Carcinoma in Cervical Lymph Node, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of the suspected lesions that are positive by the gold standard of pathology (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.