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

NCT ID: NCT02678884

Last Updated: 2024-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2028-11-30

Brief Summary

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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

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Conditions

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Head and Neck Squamous Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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HNSCC Patients receiving RT

Group Type EXPERIMENTAL

18-F FDG

Intervention Type DRUG

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

Interventions

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18-F FDG

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John J Kim, MD

Role: PRINCIPAL_INVESTIGATOR

The Princess Margaret Cancer Foundation

Locations

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University Health Network, Princess Margaret Cancer Center

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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John J Kim, MD

Role: CONTACT

416 946 4501 ext. 2126

Stephen Breen, PhD

Role: CONTACT

416 946 4501 ext. 5812

Facility Contacts

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John J Kim, MD

Role: primary

416 946 4501 ext. 2126

Stephen Breen, PhD

Role: backup

416 946 4501 ext. 5812

Other Identifiers

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UHN REB 12-5378-CE

Identifier Type: -

Identifier Source: org_study_id

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