Background: PET is currently being used in several onco-hematological clinical trials to assess therapy response and predict outcome. Reliability of PET data is assured through the use of a thorough program of clinical trial qualification of PET scanners. Aims: To present the results of the procedure for qualifying PET scanners for Clinical Trial (CTQ) adopted by the Italian Foundation on Lymphoma (FIL), International Extra Nodal Lymphoma Research Group (IELSG) and Spanish lymphoma group (GELTAMO). Patients and methods: Uniform and image quality NEMA/IEC phantoms acquired by local personnel with standard acquisition and reconstruction techniques were uploaded to a central server and analyzed within the CoreLab. Measured activity concentration (AC) was compared to expected values in the uniform phantom. Recovery coefficient (RC) curve was calculated in the NEMA/IEC phantom and compared to EANM guidelines. Results: At present 76 scanners have been CTQed. The CTQ was carried out with a single iteration in 22% of sites, with two in 27%, three in 27% and ≥ 3 in 24%. The problems during CTQ were: (a) incorrect sphere filling (filled with wrong activity in five cases, with presence of bubbles in two cases and with only four sphere hot in 12 cases), (b) a measured activity different from that expected (14 cases), (c) missing data for reference activity calculation (10 cases) or CT images (3 cases), (d) difference between measured and expected activity (14 cases), (e) missing data for activity calculation (6 cases), (f) uploaded images were not in DICOM format (1 case), and (g) a wrong reconstruction algorithm was applied to the images (5 cases). Two PET sites acquired a NEMA/IEC phantom after CTQ request and one a dose calibrator source. Difference in expected versus measured AC in the uniform phantom were (1.2 ± 7%) ranging from −9.8% to 9.9%. Conclusions: Despite the EAMN recommendation not all the PET sites have a quality program in place.
PET scanner clinical trial qualification for worldwide onco-hematological studies / Chauvie, Stephane; Biggi, Alberto; Versari, Annibale; Guerra, Luca; Ceriani, Luca; Monica, Coronado; Luminari, Stefano; Federico, Massimo; Zucca, Emanuele; Martelli, Maurizio; Caballero, Dolores; Gallamini, Andrea. - In: LEUKEMIA & LYMPHOMA. - ISSN 1042-8194. - STAMPA. - 56:(2015), pp. 1239-1239.
PET scanner clinical trial qualification for worldwide onco-hematological studies
Martelli, Maurizio;
2015
Abstract
Background: PET is currently being used in several onco-hematological clinical trials to assess therapy response and predict outcome. Reliability of PET data is assured through the use of a thorough program of clinical trial qualification of PET scanners. Aims: To present the results of the procedure for qualifying PET scanners for Clinical Trial (CTQ) adopted by the Italian Foundation on Lymphoma (FIL), International Extra Nodal Lymphoma Research Group (IELSG) and Spanish lymphoma group (GELTAMO). Patients and methods: Uniform and image quality NEMA/IEC phantoms acquired by local personnel with standard acquisition and reconstruction techniques were uploaded to a central server and analyzed within the CoreLab. Measured activity concentration (AC) was compared to expected values in the uniform phantom. Recovery coefficient (RC) curve was calculated in the NEMA/IEC phantom and compared to EANM guidelines. Results: At present 76 scanners have been CTQed. The CTQ was carried out with a single iteration in 22% of sites, with two in 27%, three in 27% and ≥ 3 in 24%. The problems during CTQ were: (a) incorrect sphere filling (filled with wrong activity in five cases, with presence of bubbles in two cases and with only four sphere hot in 12 cases), (b) a measured activity different from that expected (14 cases), (c) missing data for reference activity calculation (10 cases) or CT images (3 cases), (d) difference between measured and expected activity (14 cases), (e) missing data for activity calculation (6 cases), (f) uploaded images were not in DICOM format (1 case), and (g) a wrong reconstruction algorithm was applied to the images (5 cases). Two PET sites acquired a NEMA/IEC phantom after CTQ request and one a dose calibrator source. Difference in expected versus measured AC in the uniform phantom were (1.2 ± 7%) ranging from −9.8% to 9.9%. Conclusions: Despite the EAMN recommendation not all the PET sites have a quality program in place.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
