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NCT Number: NCT02678884

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

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.

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Key information

Conditions

Head and Neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network, Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

Location status: Recruiting

Location contact

John J Kim, MD

CONTACT

[email protected]

416 946 4501 ext. 2126

John J Kim, MD

PRINCIPAL_INVESTIGATOR

Stephen Breen, PhD

CONTACT

[email protected]

416 946 4501 ext. 5812

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18-F FDG

Drug

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

Primary outcomes

  1. Measure rate constant of 18F-FDG uptake in tumour and normal tissue with dynamic PET scanning before radiotherapy.

    Time frame: ~ 2 years

Secondary outcomes

  1. Measure rate constant of 18F-FDG uptake in tumour and inflammatory tissue with dynamic PET scanning during radiotherapy .

    Time frame: ~ 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

John J Kim, MD

CONTACT

[email protected]

416 946 4501 ext. 2126

Stephen Breen, PhD

CONTACT

[email protected]

416 946 4501 ext. 5812

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2028
Study completion
2028
First posted
Feb 10, 2016
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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