Head and Neck Squamous Cell Carcinoma (HNSCC)PET-CT Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 18-F FDG.
- Who it may be relevant to
- Registry conditions: Head and Neck Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Pilot Study of 18F-FDG PET-CT Kinetic Analysis in Head and Neck Squamous Cell Carcinoma (HNSCC)
Overview
The purpose of this study is to see how useful the information provided from Positron Emission Tomography (PET) scans can be in the actual planning and delivery of radiation treatment to patients who have head and neck cancers. Patients participating in this study, will have (in addition to their routine tests) a PET scan before and during their radiation treatment. Following the intervention, patients will be followed as per standard practice.
Interventions
- Drug 18-F FDG
All patients enrolled in this study will receive 2 PET Scans: One prior to Radiation, and one during Radiation.
Primary outcome measures
- Measure rate constant of 18F-FDG uptake in tumour and normal tissue with dynamic PET scanning before radiotherapy. [Time frame: ~ 2 years]
Secondary outcome measures (1)
- Measure rate constant of 18F-FDG uptake in tumour and inflammatory tissue with dynamic PET scanning during radiotherapy . [Time frame: ~ 2 years]
Eligibility criteria
Inclusion criteria
- Non-nasopharynx head and neck mucosal squamous cell carcinoma
- Radiologically evident gross disease
- Radiotherapy alone for curative intent
- Age equal to or more than 18 years old
- To be eligible for the second study PET-CT scan: FDG avid tumour (or minimum SUV of 2.5) on the first study PET-CT scan
Exclusion criteria
- Nasopharynx cancer
- H\&N SCC skin
- Distant metastases (already known or if found on baseline CT-thorax)
- Prior malignancy within the last 5 years (exclude non-H\&N SCC, BCC skin)
- Prior chemotherapy within the last 5 years or concurrent chemotherapy/EGFR inhibitors
- Prior head and neck radiotherapy
- Inability to lie supine for study duration
- Pregnancy
- Inability to provide informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Canada · 1 center
- University Health Network, Princess Margaret Cancer Center — Toronto
Identifiers
NCT: NCT02678884 · UHN REB 12-5378-CE