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

March 12, 2024 updated by: University Health Network, Toronto

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • University Health Network, Princess Margaret Cancer Center
        • Contact:
        • Principal Investigator:
          • John J Kim, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HNSCC Patients receiving RT
Drug: 18-F FDG
All patients enrolled in this study will receive 2 PET Scans: One prior to Radiation, and one during Radiation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure rate constant of 18F-FDG uptake in tumour and normal tissue with dynamic PET scanning before radiotherapy.
Time Frame: ~ 2 years
~ 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Measure rate constant of 18F-FDG uptake in tumour and inflammatory tissue with dynamic PET scanning during radiotherapy .
Time Frame: ~ 2 years
~ 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: John J Kim, MD, The Princess Margaret Cancer Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

November 27, 2014

First Submitted That Met QC Criteria

February 5, 2016

First Posted (Estimated)

February 10, 2016

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHN REB 12-5378-CE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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