and epithelial ovarian cancer (EOC)., Colorectal cancer (CRC), gastric cancer (GC), invasive lobular breast cancer (ILC), pancreatic ductal adenocarcinoma (PDAC)
Conditions
Brief summary
Co-primary endpoints of sensitivity and specificity of [68Ga]BED003 PET/CT compared to composite standard of truth (SOT; region level: peritoneum).
Detailed description
1. Sensitivity, specificity, positive predictive value, and negative predictive value with [ 68Ga]BED003 PET/CT compared to composite SOT (region and participant level)., 2. Standardised uptake values and tumour-to-background ratios., 3. Adverse events and serious adverse events., 4. Comparison of tumour-to-background ratios and reader assessments of diagnostic quality at 30 and 60 minutes post-[ 68Ga]BED003 injection., 5. Reader assessments of diagnostic quality based on simulated reduced count data.
Interventions
DRUG[68Ga]BED003 injection
Sponsors
Blue Earth Diagnostics Ireland Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-primary endpoints of sensitivity and specificity of [68Ga]BED003 PET/CT compared to composite standard of truth (SOT; region level: peritoneum). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sensitivity, specificity, positive predictive value, and negative predictive value with [ 68Ga]BED003 PET/CT compared to composite SOT (region and participant level)., 2. Standardised uptake values and tumour-to-background ratios., 3. Adverse events and serious adverse events., 4. Comparison of tumour-to-background ratios and reader assessments of diagnostic quality at 30 and 60 minutes post-[ 68Ga]BED003 injection., 5. Reader assessments of diagnostic quality based on simulated reduced count data. | — |
Outcome results
None listed