본문바로가기



  • Status : Approved
    • First Submitted Date : 2019/05/13
    • Registered Date : 2019/05/15
    • Last Updated Date : 2019/05/15
  • 페이스북공유하기
  • 트위터공유하기
  • 구글플러스공유하기
  • 카카오스토리공유하기
  • 네이버밴드공유하기
  • 출력

1. Background

Background Information
CRIS
Registration Number
KCT0003924 
Unique Protocol ID KCCHNM201812 
Public/Brief Title Evaluation of new PET tracer, [F-18]Florastamin for diagnosing prostate cancer 
Scientific Title PET imaging of prostate cancer using [F-18]Florastamin for pharmacokinetics study: Microdose PET clinical trial  
Acronym  
MFDS Regulated Study Yes
IND/IDE Protocol  
Registered
at Other Registry
No
Healthcare Benefit
Approval Status
Not applicable

2. Institutional Review Board/Ethics Committee

Institutional Review Board Information
Board Approval Status Submitted approval 
Board Approval Number KIRAMS 2018-12-006-001 
Approval Date 2019-01-25 
Institutional Review Board  
Name KCCH Institutional Review Board 
Address 75, Nowon-ro, Nowon-gu, Seoul 
Telephone 02-970-1389 
Data Monitoring Committee    

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Kanghyon Song 
Title Doctor 
Telephone +82-2-970-7171 
Affiliation Korea Cancer Center Hospital 
Address 75, Nowon-ro Nowon-gu Seoul. 
Contact Person for Public Queries
Name Inki Lee 
Title Doctor 
Telephone +82-2-970-2241 
Affiliation Korea Cancer Center Hospital 
Address 75, Nowon-ro Nowon-gu Seoul. 
Contact Person for Updating Information
Name Inki Lee 
Title Doctor 
Telephone +82-2-970-2241 
Affiliation Korea Cancer Center Hospital 
Address 75, Nowon-ro Nowon-gu Seoul. 

4. Status

Status Information
Study Site Single
Overall Recruitment Status Recruiting  
Date of First Enrollment 2019-02-11 , Actual
Target Number of Participant 6
Primary Completion Date 2019-12-23 , Anticipated
Study Completion Date 2020-01-23 , Anticipated
Recruitment Status by Participating Study Site 1
Name of Study Site Korea Cancer Center Hospital 
Recruitment Status Recruiting  
Date of First Enrollment 2019-02-11 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Korea Cancer Center Hospital 
Organization Type Medical Institute  
Project ID  

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Korea Cancer Center Hospital 
Organization Type Medical Institute  

7. Study Summary

Study Summary Information
Lay Summary 1. Purpose: To evaluate the pharmacokinetic properties of [F-18]Florastamin in patients with prostate cancer and normal people
2. Background: The patients with prostate cancer usually underwent radical prostatectomy, external radiation therapy, and brachytherapy after diagnosis. However, 20-50% of the patients show a biochemical recurrence. Biochemical recurrence is suspected of recurrence due to elevated serum PSA level, but it is characterized by no definite abnormal anatomical change with the conventional imaging tools including CT, MRI, or bone scan. In the case of the prostate cancer patient with a biochemical recurrence, it is recommended that radiation therapy should be performed form an early stage because distant metastasis may progress if the patient is not properly treated. However, there are limitations in confirming the lesions with conventional imaging techniques, and when a conventional imaging test can identify the recurred lesion, the serum PSA level will reach a significantly high value. To overcome these limitations, it is important to noninvasively evaluate the expression of PSMA at the molecular level using radioactive isotopes. In the U.S. and Germany, several clinical trials for F-18 labeled PSMA compounds are conducted. However, clinical studies regarding F-18 labeled PSMA compound has not yet been done in Korea. Therefore, it is necessary to evaluate its usefulness in Korea using [F-18]Florastamin, a new PET tracer for the diagnosis of prostate cancer.
3. Methods: After intravenous injection of 370MBq of [F-18]Florastamin, [F-18]Florastamin PET/CT is performed. PET/CT images are acquired from head to femur with list mode during 90 mins after injection of [F-18]Florastamin. Additional images are obtained during 30mins at 120 mins from [F-18]Florastamin injection. The subject's blood sample is collected at 30 mins, 90 mins, and 150 mins after the injection of [F-18]Florastamin. After the subject urinates before the PET/CT, the urine sample after the first and second PET/CT are collected and analyzed.  

8. Study Design

Study Design Information
Study Type Interventional Study 
Study Purpose Diagnosis    
Phase Phase0 
Intervention Model Single Group  
Blinding/Masking Open 
Allocation Not Applicable 
Intervention Type Drug, Radiation  
Intervention Description After a single intravenous injection of 370MBq of [F-18]Florastamin, PET/CT images are acquired.  
Number of Arms
Arm 1 Arm Label [F-18]Florastamin administration group 
Target Number of Participant
Arm Type Experimental 
Arm Description After a single intravenous injection of 370MBq of [F-18]Florastamin, PET/CT images are acquired. 

9. Subject Eligibility

Subject Eligibility Information
Condition(s) / Problem(s) * Neoplasms
 Prostatic Cancer
Rare Disease No
Inclusion
Criteria
Gender Male 
Age 19 Year ~ No Limit
Description # Prostate cancer patients
1. Histologically diagnosed prostate cancer patient
- diagnosed with prostate cancer with a biopsy
- patient with an elevated prostate-specific antigen (PSA) after prostatectomy or radiation treatment
- Clinically confirmed with the progression of prostate cancer
2. Able to provide informed consent and have signed an approved consent form that conforms to institutional guidelines to ensure compliance
3. Men with age =/> 19 years
4. ECOG (Eastern Cooperative Oncology Group) Performance scale ≤2
5. The life expectancy of greater than or equal to 12 months.
6. Those who satisfy the following conditions in a blood test
- Platelet count (PLT) ≥ 100,000 / μL
- Blood Urea Nitrogen (BUN) and serum creatine < 1.5 x upper normal limit (ULN)
- AST (aspartate transaminase) and ALT (alanine aminotransferase) < 2.5 x upper normal limit (ULN)
- If a subject has a history of heart disease, left ventricular ejection fraction (LVEF) > 60%

# Normal subject
1. A person without any history of cancer, including prostate cancer
2. Men with age =/> 19 years
3. Able to provide informed consent and have signed an approved consent form that conforms to institutional guidelines to ensure compliance  
Exclusion Criteria 1. A person who is judged to be difficult to perform a clinical trial due to a serious medical condition
2. The person who is determined to have a mental disorder that is difficult to perform PET (Positron Emission Tomography) scan
3. Those participating in other clinical trials at screening and participating in clinical trials should be able to influence the acquisition of [F-18]Florastamin PET (Positron Emission Tomography) images from the time of registration until the end of the study, or that may affect the safety assessment following intravenous injection of [F-18]Florastamin (For example, if you are participating in another cohort-based trial that is simply focused on monitoring that you do not receive medicines during screening, you can participate in the current clinical trials.)
4. Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
5. Vulnerable subjects (researchers or students who participated in the research, family members, researchers or students of researchers participating in the research)
6. A normal subject whose PSA result is not within the normal range of:
- Less than 40 years: 1.4ng/ml or lower, 40-49 years: 2.0ng/ml or lower, 50-59 years: 3.1ng/ml or lower, 60-69 years: 4.1ng/ml or lower, 70years or older: 4.4ng/ml or less  
Healthy Volunteers Yes

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Pharmacokinetics 
Primary Outcome(s) 1 
Outcome Time dependent [F-18]Florastamin uptake at the tumor, maximum standardized uptake value (SUVmax) 
Timepoint 0min, 10mins, 31mins, 71mins, and 120mins after [F-18]Florastamin injection 
Primary Outcome(s) 2 
Outcome Time dependent [F-18]Florastamin uptake at the liver, mean standardized uptake value (SUVmean) 
Timepoint 0min, 10mins, 31mins, 71mins, and 120mins after [F-18]Florastamin injection 
Primary Outcome(s) 3 
Outcome Time dependent [F-18]Florastamin uptake at the blood pool, mean standardized uptake value (SUVmean) 
Timepoint 0min, 10mins, 31mins, 71mins, and 120mins after [F-18]Florastamin injection 
Primary Outcome(s) 4 
Outcome Time dependent [F-18]Florastamin tumor/liver uptake ratio (T/L ratio; SUVmax of tumor/ SUVmean of liver) 
Timepoint 0min, 10mins, 31mins, 71mins, and 120mins after [F-18]Florastamin injection 
Primary Outcome(s) 5 
Outcome Time dependent [F-18]Florastamin tumor/blood pool uptake ratio (T/L ratio; SUVmax of tumor/ SUVmean of blood pool) 
Timepoint 0min, 10mins, 31mins, 71mins, and 120mins after [F-18]Florastamin injection 
Secondary Outcome(s) 1 
Outcome Time dependent [F-18]Florastamin uptake at the blood pool (SUVmean of organ): bladder, kidney, spleen, whole body 
Timepoint 0min, 10mins, 31mins, 71mins, and 120mins after [F-18]Florastamin injection 

11. Study Results and Publication

Study Results and Publication Information
Result Registerd No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement Undecided 
  • 출력
Quick Link
자주하시는 질문
Q&A
등록절차
입력항목설명집