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PET-CT Scans for Head and Neck Cancer
N/A
Recruiting
Led By John J Kim, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Non-nasopharynx head and neck mucosal squamous cell carcinoma
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ~ 2 years
Awards & highlights
Study Summary
This trial is testing how well PET scans can help plan and give radiation therapy to people with head and neck cancer.
Who is the study for?
This trial is for adults with non-nasopharynx head and neck cancers who haven't had chemotherapy or radiotherapy in the last 5 years. They should have visible cancer that's treatable with radiation alone, and a tumor that shows up on PET scans. Pregnant individuals or those unable to consent are excluded.Check my eligibility
What is being tested?
The study is testing how helpful PET scans are before and during radiation treatment for head and neck cancer patients. It aims to improve treatment planning by using additional PET scan data alongside routine tests.See study design
What are the potential side effects?
While the trial focuses on imaging rather than drugs, potential side effects may include discomfort from lying still during the scan, anxiety from being in a confined space, and exposure to low levels of radiation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a type of squamous cell not in the nasopharynx area.
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My tumor showed high activity on the initial PET-CT scan.
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I am 18 years old or older.
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I have received radiotherapy with the goal of curing my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~~ 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Positron-Emission Tomography
Secondary outcome measures
Measure rate constant of 18F-FDG uptake in tumour and inflammatory tissue with dynamic PET scanning during radiotherapy .
Side effects data
From 2015 Phase 2 trial • 59 Patients • NCT0114605429%
Anemia
29%
Lymphocyte count decreased
27%
Anorexia
27%
Fatigue
24%
Abdominal Pain
12%
Nausea
10%
Platelet Count Decreased
8%
Dyspepsia
6%
Constipation
2%
Duodenal hemorrhage
2%
Duodenal Ulcer
2%
Dehydration
2%
Sepsis
2%
Duodenal Fistula
100%
80%
60%
40%
20%
0%
Study treatment Arm
SBRT and Gemzar
Trial Design
1Treatment groups
Experimental Treatment
Group I: HNSCC Patients receiving RTExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,474 Previous Clinical Trials
485,022 Total Patients Enrolled
John J Kim, MDPrincipal InvestigatorThe Princess Margaret Cancer Foundation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot lie on my back for an extended period.My cancer is a type of squamous cell not in the nasopharynx area.I have had radiotherapy for head or neck cancer.My tumor showed high activity on the initial PET-CT scan.I am 18 years old or older.I have not had chemotherapy or EGFR inhibitors in the last 5 years.I have cancer in the upper part of my throat behind the nose.I have received radiotherapy with the goal of curing my condition.I have not had any cancer except for skin cancer in the last 5 years.My cancer has spread to distant parts of my body.I have squamous cell carcinoma of the head and neck.
Research Study Groups:
This trial has the following groups:- Group 1: HNSCC Patients receiving RT
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any registration openings for this clinical trial?
"Affirmative. Data hosted on clinicaltrials.gov confirms that this scientific experiment, which was initially posted on October 1st 2014, is presently looking for volunteers. Specifically, they are seeking 20 participants between one location."
Answered by AI
Has 18-F FDG been investigated in past clinical trials?
"At present, 18-F FDG is the subject of 18 concurrent trials with one in its last phase. These studies are centered in Warsaw, Mazovian but span 19 diverse locations around the world."
Answered by AI
What is the aggregate population involved in this clinical experiment?
"Affirmative. The information hosted on clinicaltrials.gov states that this study, which was first posted in October 1st 2014, is actively recruiting participants from a single medical centre with the goal of enrolling 20 patients."
Answered by AI
What conditions has 18-F FDG proven to be most efficacious in treating?
"Seizures and epileptic episodes are commonly managed with 18-F FDG. This therapeutic agent is also employed to treat coronary artery disease, malignancies, and it can be used in positron emission tomography scans."
Answered by AI
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