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Fluciclovine F18 Imaging for Metastatic Head and Neck Cancer

Q: Is there an ongoing call for volunteers in this trial?

<p>Unfortunately, based on the information posted to clinicaltrials.gov this trial is not presently seeking participants. The first post was made April 24th 2019 and it last updated September 22 2022 - though there are 2,678 other trials that have open enrollment at this time.</p>

Phase < 1

Waitlist Available

Led By Maria K Gule-Monroe

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planned standard of care exam under anesthesia with oropharyngeal surgical biopsy

Adults with biopsy proven metastatic cervical nodal squamous cell carcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing if a new imaging technique can better identify the origin of head and neck cancer that has spread to the cervical lymph nodes.

Who is the study for?

This trial is for adults with metastatic cervical nodal squamous cell carcinoma who've had a CT scan that couldn't find the primary cancer site. They must be planning to have standard PET CT scans and surgical biopsies, but can't join if they're allergic to certain imaging agents, can't lie still for an hour, are pregnant, or have severe kidney issues.Check my eligibility

What is being tested?

The study is testing how well Fluciclovine F18 works in a PET/CT scan to identify where head and neck cancer started compared to the usual FDG PET-CT scans. This could help doctors plan better treatments for patients whose cancer has spread to their neck lymph nodes.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to the imaging agent Fluciclovine F18 or iodine-based contrast used during CT scans. Patients might also experience discomfort from lying still during the scanning process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for a throat biopsy under anesthesia.

Select...

I have a confirmed diagnosis of metastatic squamous cell carcinoma in my cervical lymph nodes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of the suspected lesions that are positive by the gold standard of pathology

Other outcome measures

Lesion to background (L/B) ratios for nodal metastatic disease

Sensitivity and specificity in detecting nodal disease

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (fluciclovine F18 PET/CT)Experimental Treatment3 Interventions

Patients receive fluciclovine F18 IV and undergo PET/CT scan over 20-30 minutes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fluciclovine F18

2019

Completed Phase 2

~100

Positron Emission Tomography

2008

Completed Phase 2

~2240

Computed Tomography

2017

Completed Phase 2

~2720

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,765 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,109 Total Patients Enrolled

Maria K Gule-MonroePrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

20 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an ongoing call for volunteers in this trial?

"Unfortunately, based on the information posted to clinicaltrials.gov this trial is not presently seeking participants. The first post was made April 24th 2019 and it last updated September 22 2022 - though there are 2,678 other trials that have open enrollment at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "Fluciclovine F18 PET/CT in Identifying the Origin of Head and Neck Squamous Cell Carcinoma in Patients With Metastatic Cervical Nodal Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03868020.