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

Primary Purpose

Head and Neck Squamous Cell Carcinoma

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

18-F FDG

About this trial

This is an interventional diagnostic trial for Head and Neck Squamous Cell Carcinoma focused on measuring Head and Neck Squamous Cell Carcinoma, Radiation therapy, Head and Neck Cancers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Health Network, Princess Margaret Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HNSCC Patients receiving RT

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02678884

First Posted

November 27, 2014

Last Updated

January 25, 2023

Sponsor

University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT02678884

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 2014 (undefined)

Primary Completion Date

November 2028 (Anticipated)

Study Completion Date

November 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Health Network, Toronto

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Squamous Cell Carcinoma

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HNSCC Patients receiving RT

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

18-F FDG

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

~ 2 years

Secondary Outcome Measure Information:

Title

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

Time Frame

~ 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

John J Kim, MD

Phone

416 946 4501

Ext

2126

John.kim@rmp.uhn.on.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Stephen Breen, PhD

Phone

416 946 4501

Ext

5812

Stephen.Breen@rmp.uhn.on.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John J Kim, MD

Organizational Affiliation

The Princess Margaret Cancer Foundation

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Health Network, Princess Margaret Cancer Center

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

John J Kim, MD

Phone

416 946 4501

Ext

2126

John.Kim@rmp.uhn.on.ca

First Name & Middle Initial & Last Name & Degree

Stephen Breen, PhD

Phone

416 946 4501

Ext

5812

Stephen.Breen@rmp.uhn.on.ca

First Name & Middle Initial & Last Name & Degree

John J Kim, MD

12. IPD Sharing Statement

Learn more about this trial

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

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