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Evaluation of new PET tracer, [F-18]Florastamin for diagnosing prostate cancer: Phase I clinical trial

PET imaging of prostate cancer patients using [F-18]Florastamin for safety and pharmacokinetics study: Phase I clinical trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
CRIS
Registry ID
KCT0004817
Enrollment
10
Registered
2020-03-11
Start date
2020-01-08
Completion date
Unknown
Last updated
2020-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Sponsors

FutureChem
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: # 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%

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
Time dependent [F-18]Florastamin uptake at the tumor, maximum standardized uptake value (SUVmax);Time dependent [F-18]Florastamin uptake at the liver, mean standardized uptake value (SUVmean);Time dependent [F-18]Florastamin uptake at the blood pool, mean standardized uptake value (SUVmean);Time dependent [F-18]Florastamin tumor/liver uptake ratio (T/L ratio; SUVmax of tumor/ SUVmean of liver);Time dependent [F-18]Florastamin tumor/blood pool uptake ratio (T/L ratio; SUVmax of tumor/ SUVmean of blood pool)

Secondary

MeasureTime frame
Time dependent [F-18]Florastamin uptake at the blood pool (SUVmean of organ): bladder, kidney, spleen, whole body

Countries

Korea, Republic of

Contacts

Public ContactInki Lee

Korea Cancer Center Hospital

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026