Table 3 , Comparison of EORTC and PERCIST response criteria, QIBA Profile Claims and current study

Measurable lesions

Region of high ¹⁸F-FDG uptake representing viable tumor

SULpeak (hottest tumor) ≥ (1.5 x mean liver uptake + 2 SD of liver region)

SUVmax ≥ 4 and diameter ≥ 2 cm

SULpeak (hottest tumor) ≥ (1.5 x mean liver uptake)

No change condition (stable disease for EORTC and PERCIST)

Increase in SUV < 25% or decrease of < 15% after one cycle of treatment (and < 25% after more than one treatment cycle) and no change in extent > 20%

Change in SULpeak < ± 30%, If there are other changes that indicate response or progression.

Claim 2: Increase in SUVmax < 39% and decrease in SUVmax < 28%.

SULpeak < 21% or and decrease in SULpeak <-17% or an increase in SUVmax < 19%, and decrease in SUVmax< -16% assuming a mean difference between test and retest of zero.

Conditions for valid measurements

Scanners should provide reproducible data

Normal liver SUL must be within 20% and 0.3 SUL for baseline and follow-up studies

Acquisition and analysis must comply to the QIBA Profile checklists

Same as PERCIST.

Protocol

Specified

Refers to NIH-consensus (40) and Netherlands (41) protocols

Specified

Kurland 2019 and Peterson 2018