Head and Neck Squamous Cell CarcinomaNCT02678884
Head and Neck Squamous Cell Carcinoma (HNSCC)PET-CT Pilot Study
A study testing 18-F FDG in people with Head and Neck Squamous Cell Carcinoma, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- 18-F FDG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to 13 Jan 2025
- Phase
- Interventional
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
- 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
Who cannot join
- 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
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- Inability to lie supine for study duration
- Pregnancy
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Princess Margaret Cancer Center
Toronto, Ontario, M5G 2M9
About this study
Official title: A Pilot Study of 18F-FDG PET-CT Kinetic Analysis in Head and Neck Squamous Cell Carcinoma (HNSCC)
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.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- 18-F FDG
- Keywords
- Head and Neck Squamous Cell Carcinoma, Radiation therapy, Head and Neck Cancers
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18-F FDGDrug
All patients enrolled in this study will receive 2 PET Scans: One prior to Radiation, and one during Radiation.
| Study group | Role | What they receive |
|---|---|---|
| HNSCC Patients receiving RT | Experimental | Not described Receives: Drug: 18-F FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure rate constant of 18F-FDG uptake in tumour and normal tissue with dynamic PET scanning before radiotherapy.
Measured: ~ 2 years
Secondary outcomes (1)
Measure rate constant of 18F-FDG uptake in tumour and inflammatory tissue with dynamic PET scanning during radiotherapy .
Measured: ~ 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startOct 2014
- Primary completion13 Jan 2025
- Study completion13 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John J Kim, MD, Principal investigator, The Princess Margaret Cancer Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678884
- Sponsor's protocol ID
- UHN REB 12-5378-CE
- Status last verified
- Oct 2026
- First submitted
- 27 Nov 2014
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No