Differences in Scans Between Cancer and Injection

Sponsor
University of California, Davis (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05625217
Collaborator
Colorado SPORE Developmental Research Program (Other)
12
1
1
20.1
0.6

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Total Body PET/CT Imagin
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Characterizing Dynamics of FDG Uptake With Total-Body PET for Response Assessment in Radiotherapy for Head and Neck Cancer
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Total-body PET scan

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.

Diagnostic Test: Total Body PET/CT Imagin
Total-body PET imaging at different timepoints

Outcome Measures

Primary Outcome Measures

  1. Utility of long-delayed FDG PET Imaging [Percent change from baseline to 2 hour post injection]

    The retention index based on the SUVmax for Oral Cancer and Radiotherapy-induced inflammation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 UC Davis EXPLORER Molecular Imaging Center Sacramento California United States 95816

Sponsors and Collaborators

  • University of California, Davis
  • Colorado SPORE Developmental Research Program

Investigators

  • Principal Investigator: Tokihiro Yamamoto, PhD, University of California, Davis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT05625217
Other Study ID Numbers:
  • 1946919
First Posted:
Nov 22, 2022
Last Update Posted:
Jan 31, 2023
Last Verified:
Jan 1, 2023
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 31, 2023