Standard and Delayed FDG PET/CT After Chemoradiation Therapy in Assessing Patients With Metastatic Head and Neck Squamous Cell Cancer
Dual-Time Point (DTP) FDG PET CT for the Post-Treatment Assessment of Head and Neck Tumors Following Definitive Chemoradiation Therapy
2 other identifiers
interventional
14
1 country
1
Brief Summary
This trial studies how well standard and delayed fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) given after standard radiation and chemotherapy works in assessing patients with head and neck squamous cell cancer that has spread to other places in the body. Diagnostic procedures, such as PET/CT, use radioactive material, such as fludeoxyglucose F-18, to find and diagnose head and neck tumors and may help to find out how far the disease has spread.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2018
CompletedFirst Submitted
Initial submission to the registry
June 22, 2018
CompletedFirst Posted
Study publicly available on registry
July 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2024
CompletedMay 14, 2024
May 1, 2024
5.9 years
June 22, 2018
May 13, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Optimal imaging time
Determined by fludeoxyglucose F-18 (FDG) positron emission tomography. The optimal time point is defined as the time point that meets the following requirements: 1) it has the largest average lesion/background (L/B) ratio, and 2) if the delayed time point is greater, it must be significantly different from the initial time point at the 0.025 significance level. The acquired PET data will be reconstructed using iterative techniques with resolution recovery. All delayed time points will then be registered using rigid techniques to the standard of care initial PET/CT image. Volumes of interest around the largest nodal metastasis will be drawn and the standard uptake value (SUV) max will be calculated. A corresponding region for largest nodal metastasis will be drawn on the contralateral sternocleidomastoid muscle respective to each lesion to determine L/B ratio, where L is the lesion SUV max and B is the corresponding background SUV max.
Up to 6 months
Differences in L/B ratio
Differences in L/B ratio between the initial and delayed time point will be tested via paired t-test after appropriate transformation.
Up to 6 months
Study Arms (1)
Diagnostic (FDG PET/CT)
EXPERIMENTALPatients receive fludeoxyglucose F-18 IV over 1 minute and undergo PET/CT at 70 and 180 minutes after injection at 12-14 weeks following standard CRT completion.
Interventions
Undergo FDG PET/CT
Given IV
Undergo FDG PET/CT
Eligibility Criteria
You may qualify if:
- Adult with computed tomography (CT) or fludeoxyglucose F-18 (FDG) positron emission tomography (PET) findings of cervical nodal metastasis from a head and neck primary squamous cell carcinoma treated with definitive chemoradiation
You may not qualify if:
- Children
- No evidence of cervical nodal metastasis
- Active infection of the head and neck
- Known allergy to FDG, iodine or gadolinium-based contrast agents
- Blood glucose (\> 250 mg/dl)
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason M Johnson
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2018
First Posted
July 3, 2018
Study Start
June 15, 2018
Primary Completion
May 10, 2024
Study Completion
May 10, 2024
Last Updated
May 14, 2024
Record last verified: 2024-05