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Trial Title:
[18F]-rhPSMA PET-CT Imaging Performance in Patients with Prostate Cancer
NCT ID:
NCT06580015
Condition:
Prostate Carcinoma
Conditions: Official terms:
Prostatic Neoplasms
Fluorides
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet 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 PET-CT
Arm group label:
Device Feasibility ([18F]-rhPSMA 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 axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Other
Intervention name:
Flotufolastat F-18 Gallium
Description:
Given IV
Arm group label:
Device Feasibility ([18F]-rhPSMA PET-CT, X1 RMRS PET-CT)
Other name:
(18F)-rhPSMA-7.3
Other name:
18F-rhPSMA-7.3
Other name:
18FrhPSMA-7.3
Other name:
F-18-rhPSMA-7.3
Other name:
Fluorine F 18 Radiohybrid PSMA-7.3
Other name:
Fluorine F 18 rhPSMA-7.3
Other name:
Fluorine-18 rhPSMA-7.3
Other name:
Posluma
Other name:
rhPSMA-7.3 (18F)
Intervention type:
Other
Intervention name:
Medical Device Usage and Evaluation
Description:
Undergo X1 RMRS PET-CT
Arm group label:
Device Feasibility ([18F]-rhPSMA PET-CT, X1 RMRS PET-CT)
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET-CT
Arm group label:
Device Feasibility ([18F]-rhPSMA 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 (procedure)
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 evaluates [18F]-rh PSMA positron emission tomography (PET)-computed
tomography (CT) imaging performance in patients with prostate cancer. 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-rhPSMA. Because some
cancers take up [18F]-rhPSMA, 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. Posluma (18F-rhPSMA) is
an approved prostate-specific membrane antigen (PSMA) imaging agent for prostate cancer.
The RefleXion Medical Radiotherapy System (RMRS) is designed to facilitate delivery of
biology-guided radiotherapy (BgRT). The system uses PET emissions to guide radiotherapy
delivery in real-time and has been studied for use with fludeoxyglucose (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 radiation
therapy that will target (in real time) the signal released from the [18F]-rhPSMA PET-CT
tracer. Comparing the imaging from the standard of care [18F]-rh PSMA PET-CT with the
imaging from RMRS may help improve the quality of the imaging captured on the RMRS for
detection of imaging signals in patients with prostate cancer.
Detailed description:
PRIMARY OBJECTIVE:
I. To evaluate the imaging performance of flotufolastat F-18 gallium ([18F]-rhPSMA)
PET-CT imaging subsystem of the RefleXion Medical Radiotherapy System Device in patients
with lesions detected on standard-of-care (SOC) [18F]-rhPSMA PET-CT on the same day.
SECONDARY OBJECTIVES:
I. To evaluate the frequency that SOC Posluma imaging will result in the ability to
distinctly identify and separate PET activity from bladder activity to aid in the
detection, lesion contouring, RT planning and RT delivery for intra-prostatic lesions,
prostate bed lesions (salvage RT) or lesions near the bladder.
II. To evaluate the frequency that SOC Posluma imaging will result in a change in
radiotherapy planning through either exclusion due to extra-pelvic metastatic disease or
detection of disease that results in a modification of RT field coverage or dose.
III. Evaluate the potential for using the X1 RMRS PET used to generate an acceptable BgRT
plan such that dosimetric parameters for the target and the nearby normal anatomy are met
based on investigator assessment.
OUTLINE:
Patients receive SOC flotufolastat F-18 gallium intravenously (IV) and undergo PET-CT on
study. Patients then undergo X1 RMRS PET-CT imaging-only session 120 minutes
post-injection.
After completion of study intervention, patients are followed up within 72 hours of PET
imaging-only session.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Documented informed consent of the participant and/or legally authorized
representative
- Age: ≥ 21 years
- Patients with SOC [18F]-RhPSMA PET-CT in whom a PET avid lesion is identified
- Able to get same day X1 RMRS PET
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
Gender:
Male
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
Contact:
Last name:
Jeffrey Y. Wong
Phone:
626-218-2247
Email:
jwong@coh.org
Contact backup:
Last name:
Jeffrey Y. Wong
Start date:
December 24, 2024
Completion date:
February 4, 2026
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/NCT06580015
