To hear about similar clinical trials, please enter your email below
Trial Title:
Total-Body FDG PET for Radiotherapy Response Assessment in Head and Neck Cancer
NCT ID:
NCT05625217
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Total Body PET/CT Imagin
Description:
Total-body PET imaging at different timepoints
Arm group label:
Total-body PET scan
Summary:
The overall goal of this research study is to understand how 18F-fluorodeoxyglucose
(FDG), a radioactive sugar behaves in head and neck cancer (HNC) and inflammation
immediately following injection and at many hours post-injection, with the world's first
total-body positron emission tomography (PET)/computed tomography (CT) scanner
(EXPLORER).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Stage II-IVa (American Joint Committee on Cancer, 8th edition) OC who are planned
for RT (≥60 Gy) as per routine clinical standard.
2. Patient must be ≥18 years of age.
3. Willing and able to lay motionless in a supine position for up to 60 minutes
4. Patient must be able to provide study specific informed consent prior to study
entry.
5. Patient must be able to adhere to the study visit schedule and other protocol
requirements (including prolonged fasting).
Exclusion Criteria:
1. Prior RT for any malignancy leading to overlap with planned RT fields.
2. Prior chemotherapy for any malignancy.
3. Subjects suffering from severe claustrophobia.
4. Subjects who have had a research study involving radiation within one year of
enrolling in this study
5. Subjects who are pregnant (subjects 18 to 60 years old who are able to become
pregnant unless documented hysterectomy or bilateral ovarian removal is available
will be tested prior to injection of imaging agent - positive test will exclude from
participating in the study)
6. Subjects who are breastfeeding
7. Prisoners.
8. Any significant medical condition that in the opinion of the investigator would
prevent the subject from participating and/or adhering to study related procedures
or interfere with subject safety (e.g., poorly controlled diabetes).
9. Children (<18 years of age).
10. Body weight more than 240 kg (529 pounds)
-
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UC Davis EXPLORER Molecular Imaging Center
Address:
City:
Sacramento
Zip:
95816
Country:
United States
Start date:
February 27, 2023
Completion date:
November 2025
Lead sponsor:
Agency:
University of California, Davis
Agency class:
Other
Collaborator:
Agency:
Colorado SPORE Developmental Research Program
Agency class:
Other
Source:
University of California, Davis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05625217
