A Study of PET/CT Imaging Using INR101 Injection in Healthy Male Subjects and Patients With Suspe… (NCT06472531) | Clinical Trial Compass
CompletedPhase 1/2
A Study of PET/CT Imaging Using INR101 Injection in Healthy Male Subjects and Patients With Suspected Prostate Cancer
China32 participantsStarted 2024-05-23
Plain-language summary
Phase I/II study in the management of Healthy Male Subjects and patients with suspected prostate cancer.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males aged ≥18 years old
. Good health status or no major illness, judged by the investigator based on the following assessments: medical history, physical examination, vital signs, 12-lead electrocardiogram, laboratory tests that are normal or abnormal but not clinically significant
. Agree to use contraceptive measures from the day of signing the informed consent form until 3 months after drug administration, to avoid sperm donation;
. The subjects/legally authorized representative/guardian understands the purpose and procedures of the trial, and signs the informed consent form.
. Males aged ≥18 years
. ECOG score of 0 or 1
. Subjects who are planned to undergo prostate biopsy for pathological examination after clinical assessment, with no contraindications for biopsy
. Routine blood tests, liver and kidney function, and coagulation function meet the corresponding conditions
Exclusion criteria
. Subjects who cannot complete INR101 imaging according to the requirements
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase I primary outcome: incidence of adverse events of INR101 injection
Timeframe: 7 days after administration
2
Phase I primary outcome:radiation dosimetry
Timeframe: 3 hours after administration
3
Phase I primary outcome:Tmax (Time to reach maximum plasma concentration)
Timeframe: 4 hours after administration
4
Phase I primary outcome:t1/2 (Elimination half-life)
Timeframe: 4 hours after administration
5
Phase I primary outcome:AUC0-t (Area under the plasma concentration-time curve from time 0 to time t)
Timeframe: 4 hours after administration
6
Phase I primary outcome:AUC0-∞ (Area under the plasma concentration-time curve from time 0 to infinity)
. Subjects who cannot complete pharmacokinetics sample collection according to the requirements
. Serum virology examination (Heptitis B surface antigen,Anti-Treponema pallidum antibody,HIV antibodies,Antibody to Hepatitis C Virus) is abnormal, which is judged by the researchers to have clinical significance
. History of mental illness
. History of past malignant tumors
. History of past heart-related diseases
. History of significant brain diseases in the past
. Suffering from severe and/or poorly controlled and/or unstable diseases that the researcher judges may affect the study
8
Phase I primary outcome:Cmax (Maximum plasma concentration)
Timeframe: 4 hours after administration
9
Phase I primary outcome:SUV-standardized uptake value
Timeframe: 3 hours after administration
10
Phase I primary outcome:%ID/g - percentage of injected dose per gram
Timeframe: 3 hours after administration
11
Phase I primary outcome:residence time - residence time in the the target organs