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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02678884
Recruitment Status : Recruiting
First Posted : February 10, 2016
Last Update Posted : August 17, 2020
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE November 27, 2014
First Posted Date  ICMJE February 10, 2016
Last Update Posted Date August 17, 2020
Study Start Date  ICMJE October 2014
Estimated Primary Completion Date November 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2016)
Measure rate constant of 18F-FDG uptake in tumour and normal tissue with dynamic PET scanning before radiotherapy. [ Time Frame: ~ 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2016)
Measure rate constant of 18F-FDG uptake in tumour and inflammatory tissue with dynamic PET scanning during radiotherapy . [ Time Frame: ~ 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Head and Neck Squamous Cell Carcinoma (HNSCC)PET-CT Pilot Study
Official Title  ICMJE A Pilot Study of 18F-FDG PET-CT Kinetic Analysis in Head and Neck Squamous Cell Carcinoma (HNSCC)
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Head and Neck Squamous Cell Carcinoma
Intervention  ICMJE Drug: 18-F FDG
All patients enrolled in this study will receive 2 PET Scans: One prior to Radiation, and one during Radiation.
Study Arms  ICMJE Experimental: HNSCC Patients receiving RT
Intervention: Drug: 18-F FDG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 5, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2028
Estimated Primary Completion Date November 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: John J Kim, MD 416 946 4501 ext 2126 John.kim@rmp.uhn.on.ca
Contact: Stephen Breen, PhD 416 946 4501 ext 5812 Stephen.Breen@rmp.uhn.on.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02678884
Other Study ID Numbers  ICMJE UHN REB 12-5378-CE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John J Kim, MD University Health Network--Princess Margaret Cancer Centre
PRS Account University Health Network, Toronto
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP