Functional ImaGing of Heterogeneity in Head and Neck Tumors - Validation From Surgical Specimens
FIGHHT
1 other identifier
observational
33
1 country
1
Brief Summary
The purpose of this study is to investigate if heterogeneity in head and neck squamous cell carcinoma as seen in functional imaging with PET/MR can be correlated to biologic heterogeneity in surgical specimens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 29, 2017
CompletedFirst Submitted
Initial submission to the registry
May 16, 2017
CompletedFirst Posted
Study publicly available on registry
May 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2018
CompletedMarch 26, 2019
March 1, 2019
1.5 years
May 16, 2017
March 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Quantified measures from FDG PET and pathology
Correlation between FDG uptake (measured as SUV) and expression of IHC biomarkers
3-6 months
Quantified measures from DWI and pathology
Correlation between diffusion weighted imaging and expression of IHC biomarkers
3-6 months
Quantified measures from DCE and pathology
Correlation between dynamic contrast enhancement and expression of IHC biomarkers
3-6 months
Interventions
All patients are scanned with PET/MR prior to surgery.
Eligibility Criteria
Please see detailed description
You may qualify if:
- Informed consent
- Age above 18
- Primary or recurrent squamous cell carcinoma in the head and neck area
- Referred to surgery
- Primary tumor \> 1.5 cm and or neck metastasis of more than 1 cm.
You may not qualify if:
- Patient refusal
- Contraindications for FDG-PET/MR scan
- Pacemaker
- Severe claustrophobia
- Magnetic metal in the body that is not MR compatible
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Otorhinolaryngology, Head & Neck Surgery and Audiology Rigshospitalet, University of Copenhagen
Copenhagen, 2100, Denmark
Biospecimen
The gross specimen will be examined, sectioned and placed in tissue cassettes as done in routine. Six tissue blocks will be picked for microscopic evaluation and IHC staining. The specific selection of cancer related IHC biomarkers is based on their relationship with tumor cell metabolism, radiotherapy resistance (proliferation and hypoxia), association with FDG accumulation and institutional experience from a previous study
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
May 16, 2017
First Posted
May 19, 2017
Study Start
March 29, 2017
Primary Completion
September 30, 2018
Study Completion
December 30, 2018
Last Updated
March 26, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share