Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT02678884

Conditions

Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

18-F FDG

Study Details

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Study ID

NCT02678884

Start date

Oct, 2014

Status verified date

Mar, 2024

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: HNSCC Patients receiving RT

Interventions

18-F FDG

All patients enrolled in this study will receive 2 PET Scans: One prior to Radiation, and one during Radiation.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

John J Kim, MD

416 946 4501John.kim@rmp.uhn.on.ca

Stephen Breen, PhD

416 946 4501Stephen.Breen@rmp.uhn.on.ca

Locations

University Health Network, Princess Margaret Cancer Center

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

John J Kim, MD

416 946 4501John.Kim@rmp.uhn.on.ca

Stephen Breen, PhD

416 946 4501Stephen.Breen@rmp.uhn.on.ca

Principal Investigator:

John J Kim, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 13, 2024

Last verified

Mar, 2024

Keywords

  • Head and Neck Squamous Cell Carcinoma
  • Radiation therapy
  • Head and Neck Cancers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2024-03-13.