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Total-Body FDG PET for Radiotherapy Response Assessment in Head and Neck Cancer

Primary Purpose

Head and Neck Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Total Body PET/CT Imagin
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Head and Neck Cancer

Eligibility Criteria

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

Inclusion Criteria: Stage II-IVa (American Joint Committee on Cancer, 8th edition) OC who are planned for RT (≥60 Gy) as per routine clinical standard. Patient must be ≥18 years of age. Willing and able to lay motionless in a supine position for up to 60 minutes Patient must be able to provide study specific informed consent prior to study entry. Patient must be able to adhere to the study visit schedule and other protocol requirements (including prolonged fasting). Exclusion Criteria: Prior RT for any malignancy leading to overlap with planned RT fields. Prior chemotherapy for any malignancy. Subjects suffering from severe claustrophobia. Subjects who have had a research study involving radiation within one year of enrolling in this study 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) Subjects who are breastfeeding Prisoners. 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). Children (<18 years of age). Body weight more than 240 kg (529 pounds) -

Sites / Locations

  • UC Davis EXPLORER Molecular Imaging CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Total-body PET scan

Arm Description

All participants are asked to complete two study scan visits. First visit occurs before treatment and the second visit occurs 12 +/- 2 weeks after treatment. Each visit will involve a single injection of FDG, followed by three PET/CT scans that will start immediately following injection, at about 2 hours post-injection and at 5 hours post-injection, respectively and last about 60 minutes, 20 minutes and 20 minutes, respectively.

Outcomes

Primary Outcome Measures

Utility of long-delayed FDG PET Imaging
The retention index based on the SUVmax for Oral Cancer and Radiotherapy-induced inflammation

Secondary Outcome Measures

Full Information

First Posted
November 7, 2022
Last Updated
August 1, 2023
Sponsor
University of California, Davis
Collaborators
Colorado SPORE Developmental Research Program
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1. Study Identification

Unique Protocol Identification Number
NCT05625217
Brief Title
Total-Body FDG PET for Radiotherapy Response Assessment in Head and Neck Cancer
Official Title
Characterizing Dynamics of FDG Uptake With Total-Body PET for Response Assessment in Radiotherapy for Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
Colorado SPORE Developmental Research Program

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Total-body PET scan
Arm Type
Experimental
Arm Description
All participants are asked to complete two study scan visits. First visit occurs before treatment and the second visit occurs 12 +/- 2 weeks after treatment. Each visit will involve a single injection of FDG, followed by three PET/CT scans that will start immediately following injection, at about 2 hours post-injection and at 5 hours post-injection, respectively and last about 60 minutes, 20 minutes and 20 minutes, respectively.
Intervention Type
Diagnostic Test
Intervention Name(s)
Total Body PET/CT Imagin
Intervention Description
Total-body PET imaging at different timepoints
Primary Outcome Measure Information:
Title
Utility of long-delayed FDG PET Imaging
Description
The retention index based on the SUVmax for Oral Cancer and Radiotherapy-induced inflammation
Time Frame
Percent change from baseline to 2 hour post injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stage II-IVa (American Joint Committee on Cancer, 8th edition) OC who are planned for RT (≥60 Gy) as per routine clinical standard. Patient must be ≥18 years of age. Willing and able to lay motionless in a supine position for up to 60 minutes Patient must be able to provide study specific informed consent prior to study entry. Patient must be able to adhere to the study visit schedule and other protocol requirements (including prolonged fasting). Exclusion Criteria: Prior RT for any malignancy leading to overlap with planned RT fields. Prior chemotherapy for any malignancy. Subjects suffering from severe claustrophobia. Subjects who have had a research study involving radiation within one year of enrolling in this study 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) Subjects who are breastfeeding Prisoners. 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). Children (<18 years of age). Body weight more than 240 kg (529 pounds) -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lynda Painting
Phone
916-731-9004
Email
lpainting@ucdavis.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dana Little
Phone
916-734-7749
Email
dalittle@ucdavis.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tokihiro Yamamoto, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis EXPLORER Molecular Imaging Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynda Painting, BS
Phone
916-731-9004
Email
lpainting@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Dana Little, MS
Phone
916-734-7749
Email
dalittle@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Tokihiro Yamamoto, PhD

12. IPD Sharing Statement

Learn more about this trial

Total-Body FDG PET for Radiotherapy Response Assessment in Head and Neck Cancer

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