Feasibility analysis and safety evaluation of [99mTc]Tc-PSMA-T4 in prostate cancer diagnosis and treatment planning.
Conditions
Brief summary
The diagnostic method will be deemed a feasible approach if at least 80% of subjects in each cohort fulfil the criteria of sensitivity and specificity (for cohorts A and B only, due to lack of negative results in cohort C as consequence of inclusion criteria) of [99mTc]Tc-PSMA-T4 multi-SPECT/CT – detection of all lesions that are pathologically or radiologically confirmed or suspicious in other modalities recommended in a particular clinical situation.
Detailed description
Positive and negative predictive value: Positive predictive value defined as number of true positives x 100% / number of true positives + number of false positives Negative predictive value defined as number of true negatives x 100% / number of true negatives + number of false negatives. Safety: Frequency of adverse events (AEs).The procedure-related AEs will be recorded during the 24h of the follow-up period in each case,no later than 48h after drug administration.Dosimetry, Feasibility.
Interventions
Sponsors
Narodowe Centrum Badan Jadrowych
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The diagnostic method will be deemed a feasible approach if at least 80% of subjects in each cohort fulfil the criteria of sensitivity and specificity (for cohorts A and B only, due to lack of negative results in cohort C as consequence of inclusion criteria) of [99mTc]Tc-PSMA-T4 multi-SPECT/CT – detection of all lesions that are pathologically or radiologically confirmed or suspicious in other modalities recommended in a particular clinical situation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive and negative predictive value: Positive predictive value defined as number of true positives x 100% / number of true positives + number of false positives Negative predictive value defined as number of true negatives x 100% / number of true negatives + number of false negatives. Safety: Frequency of adverse events (AEs).The procedure-related AEs will be recorded during the 24h of the follow-up period in each case,no later than 48h after drug administration.Dosimetry, Feasibility. | — |
Countries
Poland
Outcome results
None listed