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Ga-68 PSMA-11 PET/CT in Patients With Biochemical Recurrence of Prostate Cancer: Digital PET/CT Versus Analog PET/CT

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ClinicalTrials.gov Identifier: NCT04846894
Recruitment Status : Recruiting
First Posted : April 15, 2021
Last Update Posted : April 15, 2021
Sponsor:
Information provided by (Responsible Party):
Jin-Sook Ryu, Asan Medical Center

Tracking Information
First Submitted Date  ICMJE April 13, 2021
First Posted Date  ICMJE April 15, 2021
Last Update Posted Date April 15, 2021
Actual Study Start Date  ICMJE April 13, 2021
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2021)
Detection rate and positive predictive value of Ga-68 PSMA-11 PET/CT images of digital PET/CT and analogue PET/CT [ Time Frame: 12 months ]
Comparison of detection rate and positive predictive value of Ga-68 PSMA-11 PET/CT images of digital PET/CT and analogue PET/CT in biochemical recurrence (BCR) patients
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2021)
  • Detection rate and positive predictive value of Ga-68 PSMA-11 digital and analog PET/CT according to PSA level groups [ Time Frame: 12 months ]
    Comparison of detection rate and positive predictive value of Ga-68 PSMA-11 digital and analog PET/CT according to PSA level groups in BCR patients
  • Comparison of SUVs of Ga-68 PSMA-11 digital and analog PET/CT [ Time Frame: 12 months ]
    Comparison of standardized uptake values (SUVs) of Ga-68 PSMA-11 digital and analog PET/CT
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ga-68 PSMA-11 PET/CT in Patients With Biochemical Recurrence of Prostate Cancer: Digital PET/CT Versus Analog PET/CT
Official Title  ICMJE Diagnostic Performance of Ga-68 PSMA-11 PET/CT in Patients With Biochemical Recurrence After Prostatectomy: A Comparison of Digital PET/CT and Analog PET/CT Scanner Images
Brief Summary Ga-68 PSMA-11 PET/CT is known as useful method for localizing recurred tumor lesions in prostate cancer patients with biochemical recurrence [elevated serum prostate specific antigen (PSA) after radical prostatectomy]. The recent digital PET/CT which is known to show better resolution and sensitivity than analogue PET/CT may have better performance for detecting early small recurred tumor lesions. This study is intended to compare the diagnostic performance (detection rate and positive predictive value) of Ga-68 PSMA-11 PET/CT using analogue PET/CT scanner and digital PET/CT scanner in same patients who had biochemical recurrence of prostate cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Diagnostic Test: Ga-68 PSMA-11 PET/CT imaging
Sequential PET/CT imaging using analog and digital PET/CT scanners after single intravenous injection of Ga-68 PSMA-11
Study Arms  ICMJE Experimental: Biochemical Recurrence
Prostate cancer patient with biochemical recurrence
Intervention: Diagnostic Test: Ga-68 PSMA-11 PET/CT imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 13, 2021)
43
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Preliminary study - Establishment of Ga-68 PSMA-11 PET/CT imaging conditions (three subjects)

    • Equal or more than 19 years old
    • Biopsy proven prostate cancer patients with high risk group (serum PSA> 20 ng/ml) or metastatic prostate cancer patients identified on other imaging modalities prior to Ga-68 PSMA-11 PET/CT imaging
  2. Main study (40 subjects)

    • Equal or more than 19 years old
    • Patients who had previously undergone radical prostatectomy and were histologically diagnosed with prostate cancer.
    • Patients identified with biochemical recurrence through serum PSA tests during postoperative follow-up (Serum PSA level equal or more than 0.2 ng/ml at least two times and one of the tests was conducted within one month before consent to the study) in which metastatic lesions were not found or uncertain in standard imaging modalities (abdominal/Pelvic CT, bone scan).
    • Patients who can be followed up clinically, including serum PSA tests, for at least 6 months after consent to the study at this hospital.

Exclusion Criteria:

  1. Preliminary study - Establishment of Ga-68 PSMA-11 PET/CT imaging conditions (three subjects)

    • Primary cancer other than prostate cancer has been previously diagnosed or has occurred simultaneously with prostate cancer; Previous primary cancer other than prostate cancer is a local disease and has been cured completely shall be an exception.
    • Subjects who has concurrent severe and/or uncontrolled and/or unstable medical disease (e.g. congestive heart failure, acute myocardial infarction, severe pulmonary disease, chronic renal or hepatic disease which could compromise participation in the study) based on the judgment of the investigator
    • Subjects who cannot perform PET/CT imaging due to claustrophobia, dyskinesia, anxiety disorders, etc.
  2. Main study (40 subjects)

    • Primary cancer other than prostate cancer has been previously diagnosed or has occurred simultaneously with prostate cancer; Previous primary cancer other than prostate cancer is a local disease and has been cured completely shall be an exception.
    • Subjects who cannot perform CT, bone scan, etc., which are standard diagnostic procedures for lesion localization in case of biochemical recurrence.
    • Subjects who has concurrent severe and/or uncontrolled and/or unstable medical disease (e.g. congestive heart failure, acute myocardial infarction, severe pulmonary disease, chronic renal or hepatic disease which could compromise participation in the study) based on the judgment of the investigator
    • Subjects who cannot perform PET/CT imaging due to claustrophobia, dyskinesia, anxiety disorders, etc.
    • Subjects who might make the collection of complete data difficult or impossible due to personal circumstances or other reasons, in the judgment of the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yong-il Kim, MD. PhD. +82-2-3010-4572 kyi821209@naver.com
Contact: Jin-Sook Ryu, MD.PhD. +82-2-3010-4593 jsryu2@amc.seoul.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04846894
Other Study ID Numbers  ICMJE AMC 2021-0195
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jin-Sook Ryu, Asan Medical Center
Study Sponsor  ICMJE Jin-Sook Ryu
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jin-Sook Ryu, MD.PhD. Asan Medical Center
PRS Account Asan Medical Center
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP