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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

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.

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Drug: 18-F FDG Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study of 18F-FDG PET-CT Kinetic Analysis in Head and Neck Squamous Cell Carcinoma (HNSCC)
Study Start Date : October 2014
Estimated Primary Completion Date : November 2028
Estimated Study Completion Date : November 2028

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678884


Contacts
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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

Locations
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Canada, Ontario
University Health Network, Princess Margaret Cancer Center Recruiting
Toronto, Ontario, Canada, M5G 2M9
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   
Principal Investigator: John J Kim, MD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: John J Kim, MD University Health Network--Princess Margaret Cancer Centre
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02678884    
Other Study ID Numbers: UHN REB 12-5378-CE
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020
Keywords provided by University Health Network, Toronto:
Head and Neck Squamous Cell Carcinoma
Radiation therapy
Head and Neck Cancers
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action