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Hematopoietic and Lymphoid System NeoplasmNCT05844306

RefleXion PET/CT Imaging Performance in Patients With Various Malignancies

A study testing Computed Tomography, Fludeoxyglucose F-18 and Medical Device Usage and Evaluation in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by City of Hope Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
Computed Tomography, Fludeoxyglucose F-18 and Medical Device Usage and Evaluation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
15 Mar 2023to 17 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

Other trials in United States

About this study

Official title: A Pilot Prospective Study of the RefleXion [18F]- FDG PET-CT Subsystem Imaging Performance in Patients With Various Malignancies

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

Being tested
Computed Tomography, Fludeoxyglucose F-18, Medical Device Usage and Evaluation, Positron Emission Tomography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo [18F]-FDG PET-CT

  • Fludeoxyglucose F-18Other

    Also called 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18

    Given via injection

  • Medical Device Usage and EvaluationOther

    Undergo X1 RMRS PET-CT

  • Positron Emission TomographyDevice

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan

    Undergo [18F]-FDG PET-CT

Study groups in NCT05844306
Study groupRoleWhat they receive
Device ([18F]-FDG PET-CT, X1 RMRS PET-CT)ExperimentalPatients 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.
Receives: Procedure: Computed Tomography; Other: Fludeoxyglucose F-18; Other: Medical Device Usage and Evaluation; Device: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    One key metric will be the percent of patients with lesions identified on standard of care (SOC) PET-CT that are not identified on X1 (false negatives if considering SOC the true standard).

    For the SOC [18F]-FDG PET-CT, the maximum standard uptake value (SUV) and the greatest dimension in centimeters will be recorded for each PET avid malignant lesion identified by the nuclear medicine radiologist. The patient's radiation oncologist will interpret the X1 PET scan for the same metrics.

    Graphical presentations will be provided to compare SOC positive lesions and X1 positive lesions, and SOC positive lesions and X1 negative lesions with regards to lesion size, lesion location (lymph nodes, soft tissue, visceral organ) and SUV uptake. Descriptive statistics will be utilized to quantify results. Mean, standard deviation, interquartile range (IQR), and range will be reported for each continuous variable. Frequency and percentage will be reported for categorical variables.

    Measured: Up to 72 hours

Secondary outcomes (1)

  1. Percent of cases where X1 RMRS PET data can be used to generate an acceptable biology-guided radiotherapy (BgRT) plan

    The true positive lesions identified on the X1 PET images will be identified and used for BgRT planning. Simulated planning using the RefleXion treatment planning software will be performed, and the radiation dose to organs at risk calculated. Principal investigator will determine whether this plan is acceptable or not. The percent of cases in which RefleXion [18F]-FDG PET data led to an acceptable plan will be recorded (descriptive statistics). Descriptive statistics will be utilized to quantify results. Mean, standard deviation, IQR, and range will be reported for each continuous variable. Frequency and percentage will be reported for categorical variables.

    Measured: Up to 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start15 Mar 2023
  3. Primary completion17 Aug 2027 (estimated)
  4. Study completion17 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05844306
Sponsor's protocol ID
22668
Other IDs
NCI-2023-01994, 22668, P30CA033572
Status last verified
Sep 2026
First submitted
16 Mar 2023
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Computed Tomography, Fludeoxyglucose F-18 and Medical Device Usage and Evaluation in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by City of Hope Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Up to 72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05844306.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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