Use of DOTATOC labeled with V-Cu64 in PET-CT imaging of neuroendocrine tumors

Conditions

Neoplasms

Brief summary

Demonstration of the bioequivalence of the V-Cu64 radiopharmaceutical precursor to 68Ga based on number of visualized lesions between interventions. Number of visualized lesions (visualization of at least the same lesions between interventions) for 95% of the study population, Demonstration of bioequivalence of the V-Cu64 radiopharmaceutical precursor to 68Ga based on: SUV_MAX measurement of lesions imaged in both interventions. Accuracy in SUV_MAX measurement of lesions imaged in both interventions, SUV_MAX in the copper study not less than 90% of SUV_MAX in the 68Ga study for each lesion for 95% of the population, averaged result for descriptions by two independent physicians.

Detailed description

Safety monitoring. Collection of data on adverse events

Related papers

No related papers found yet.

Interventions

DRUGV-Ga68 500 MBq/mL

DRUGprekursor radiofarmaceutyku

DRUGroztwór

DRUGV-Cu64

DRUGGALLIUM (68GA) EDOTREOTIDE

DRUGSomaKit TOC 40 micrograms kit for radiopharmaceutical preparation

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Demonstration of the bioequivalence of the V-Cu64 radiopharmaceutical precursor to 68Ga based on number of visualized lesions between interventions. Number of visualized lesions (visualization of at least the same lesions between interventions) for 95% of the study population, Demonstration of bioequivalence of the V-Cu64 radiopharmaceutical precursor to 68Ga based on: SUV_MAX measurement of lesions imaged in both interventions. Accuracy in SUV_MAX measurement of lesions imaged in both interventions, SUV_MAX in the copper study not less than 90% of SUV_MAX in the 68Ga study for each lesion for 95% of the population, averaged result for descriptions by two independent physicians.	—

Measure

Time frame

Demonstration of the bioequivalence of the V-Cu64 radiopharmaceutical precursor to 68Ga based on number of visualized lesions between interventions. Number of visualized lesions (visualization of at least the same lesions between interventions) for 95% of the study population, Demonstration of bioequivalence of the V-Cu64 radiopharmaceutical precursor to 68Ga based on: SUV_MAX measurement of lesions imaged in both interventions. Accuracy in SUV_MAX measurement of lesions imaged in both interventions, SUV_MAX in the copper study not less than 90% of SUV_MAX in the 68Ga study for each lesion for 95% of the population, averaged result for descriptions by two independent physicians.

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Secondary

Measure	Time frame
Safety monitoring. Collection of data on adverse events	—

Outcome results

None listed