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NCT02678884 Clinical Trial

Head and Neck Squamous Cell Carcinoma (HNSCC)PET-CT Pilot Study

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:
A Pilot Study of 18F-FDG PET-CT Kinetic Analysis in Head and Neck Squamous Cell Carcinoma (HNSCC)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02678884
Other study ID # UHN REB 12-5378-CE
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 2014
Est. completion date November 2028

Study information
Verified date March 2024
Source University Health Network, Toronto
Contact John J Kim, MD
Phone 416 946 4501
Email John.kim@rmp.uhn.on.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date November 2028
Est. primary completion date November 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 18-F FDG
All patients enrolled in this study will receive 2 PET Scans: One prior to Radiation, and one during Radiation.

Locations
Country Name City State
Canada University Health Network, Princess Margaret Cancer Center Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measure rate constant of 18F-FDG uptake in tumour and normal tissue with dynamic PET scanning before radiotherapy. ~ 2 years
Secondary Measure rate constant of 18F-FDG uptake in tumour and inflammatory tissue with dynamic PET scanning during radiotherapy . ~ 2 years
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