Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580015
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
18F-rhPSMA PET-CT Imaging Performance in Patients with Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Posluma 18F-rhPSMA PET Guided Radiotherapy Planning in Prostate Cancer a Prospective Study Evaluating POSLUMA PET Tumor Detection on Radiation Therapy Planning and on BGRT Planning on the RefleXion X1 System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None