Clinical trial NCT05844306: RefleXion PET/CT Imaging Performance in Patients With Various Malignancies
Official title: A Pilot Prospective Study of the RefleXion [18F]- FDG PET-CT Subsystem Imaging Performance in Patients With Various Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-05-06
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

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

Primary outcomes:
measure: Imaging performance of X1 RefleXion Medical Radiotherapy System (RMRS) positron emission tomography (PET)-computed tomography (CT) with the Imaging performance of the diagnostic fludeoxyglucose F-18 ([18F]-FDG) PET-CT
timeFrame: Up to 72 hours
Secondary outcomes:
measure: Percent of cases where X1 RMRS PET data can be used to generate an acceptable biology-guided radiotherapy (BgRT) plan
timeFrame: Up to 72 hours
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Jeffrey Y Wong
role: PRINCIPAL_INVESTIGATOR
References: