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Trial Title:
RefleXion PET/CT Imaging Performance in Patients With Various Malignancies
NCT ID:
NCT05844306
Condition:
Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Conditions: Official terms:
Neoplasms
Deoxyglucose
Fluorodeoxyglucose F18
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Device Feasibility
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo [18F]-FDG PET-CT
Arm group label:
Device ([18F]-FDG PET-CT, X1 RMRS PET-CT)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Other
Intervention name:
Fludeoxyglucose F-18
Description:
Given via injection
Arm group label:
Device ([18F]-FDG PET-CT, X1 RMRS PET-CT)
Other name:
18FDG
Other name:
FDG
Other name:
Fludeoxyglucose (18F)
Other name:
fludeoxyglucose F 18
Other name:
Fludeoxyglucose F18
Other name:
Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
Other name:
Fluorodeoxyglucose F18
Intervention type:
Other
Intervention name:
Medical Device Usage and Evaluation
Description:
Undergo X1 RMRS PET-CT
Arm group label:
Device ([18F]-FDG PET-CT, X1 RMRS PET-CT)
Intervention type:
Device
Intervention name:
Positron Emission Tomography
Description:
Undergo [18F]-FDG PET-CT
Arm group label:
Device ([18F]-FDG PET-CT, X1 RMRS PET-CT)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Summary:
This clinical trial examines RefleXion Medical Radiotherapy System (RMRS) imaging to the
standard of care (SOC) fludeoxyglucose F-18 ([18F]-FDG)- positron emission tomography
(PET)-computed tomography (CT) imaging in patients with various cancers (malignancies).
PET is an established imaging technique that utilizes small amounts of radioactivity
attached to very minimal amounts of tracer, in the case of this research, [18F]-FDG.
Because some cancers take up [18F]-FDG, cancer cells can be seen with PET. CT utilizes
x-rays that traverse body from the outside. CT images provide an exact outline of organs
and potential inflammatory tissue where it occurs in patient's body. The RefleXion system
is designed to facilitate delivery of biology-guided radiotherapy (BgRT). The RMRS uses
PET emissions to guide radiotherapy delivery in real-time and has been studied for use
with FDG (which is an agent used in standard PET-CT scans that targets glucose).
Information gathered from this study may help researchers to improve PET-CT imaging on
the RefleXion system. This information will be used in the future to improve planning and
delivery of radiotherapy that will target (in real time) the signal released from the
[18F]-FDG-PET-CT tracer. Comparing the imaging from the standard of care [18F]-FDG-PET-CT
with the [18F]-FDG imaging from RMRS may help improve the quality of the imaging captured
and determine if imaging can be done on the RMRS at the same time as planning for
radiation therapy, which would reduce the number of scans needed to plan for radiation
for cancer.
Detailed description:
PRIMARY OBJECTIVE:
I. To assess imaging performance of the [18F]-FDG PET-CT subsystem on the X1 RMRS to
detect lesions (primary and metastatic) in patients with various types of malignancies.
SECONDARY OBJECTIVE:
I. To determine the feasibility of generating a BgRT plan using X1 RMRS-acquired
[18F]-FDG PET data derived from the imaging-only session at the studied dose level.
OUTLINE:
Patients receive [18F]-FDG injection and undergo SOC [18F]-FDG PET-CT on study. Patients
with at least one PET avid lesion then undergo X1 RMRS PET-CT imaging-only session on
study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Documented informed consent of the participant and/or legally authorized
representative
- Age: >= 21 years
- Patients with malignancies (abdominal/pelvic/thoracic/head and neck/breast tumors)
undergoing SOC [18F]-FDG PET-CT for diagnostic and/or radiotherapy planning purposes
- Patients should be scheduled for [18F]-FDG PET-CT prior to study entry
Exclusion Criteria:
- Known psychiatric or substance abuse disorder that would interfere with conduct of
the study
- Patient weight exceeding the weight limit (450 pounds) outlined per X1 RMRS
specifications sheet
- Lung parenchymal and bone tumors will be excluded as their imaging characteristics
were evaluated in a previous study
Gender:
All
Minimum age:
21 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jeffrey Y. Wong
Phone:
626-218-2247
Email:
jwong@coh.org
Investigator:
Last name:
Jeffrey Y. Wong
Email:
Principal Investigator
Start date:
March 15, 2023
Completion date:
February 28, 2025
Lead sponsor:
Agency:
City of Hope Medical Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
City of Hope Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05844306
