Neuroendocrine Tumor
Conditions
Brief summary
• Difference in progression free survival between NEN patients treated with dosimetry based versus standard PRRT. Defined as time from randomization to documented disease progression or death by any cause, evaluated by CT, RECIST 1.1.
Detailed description
• Difference in tumor dose between dosimetry based and standard PRRT treatment groups • Difference in kidney toxicity between dosimetry based and standard PRRT treatment groups, measured by creatine, eGFR, cystatin-c, Tc-DTPA clearance, and kidney fibrosis markers PRO-6, C3M and LAMC1. • Difference in bone marrow function between dosimetry based and standard PRRT treatment groups, measured by hemoglobin, white blood cells, platelets. • Difference in subjective side effects between dosimetry bas
Interventions
DRUG177Lu-DOTATOC
Sponsors
Region Midtjylland
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Difference in progression free survival between NEN patients treated with dosimetry based versus standard PRRT. Defined as time from randomization to documented disease progression or death by any cause, evaluated by CT, RECIST 1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Difference in tumor dose between dosimetry based and standard PRRT treatment groups • Difference in kidney toxicity between dosimetry based and standard PRRT treatment groups, measured by creatine, eGFR, cystatin-c, Tc-DTPA clearance, and kidney fibrosis markers PRO-6, C3M and LAMC1. • Difference in bone marrow function between dosimetry based and standard PRRT treatment groups, measured by hemoglobin, white blood cells, platelets. • Difference in subjective side effects between dosimetry bas | — |
Countries
Denmark
Outcome results
None listed