Table 3.

Number of healthy volunteer (HV) and multiple myeloma (MM) scans in each category for each study phase

	HV*	MM inactive	MM active focal	MM active diffuse	MM new diagnosis	Total
Phase 1†	40	40	60	40	20	200
Phase 2	50	100	105	70	28	353
Phase 3 training‡	0	(80 post-treatment)	60	40	20	200
Phase 3 validation	0	60 patients in iTIMM study scanned at baseline and post-treatment				120

*A total of 50 HV will be used, 40 in phase 1, which will be used again in phase 2, with the addition of 10 more HV.

†The number of scans in phase 1 may increase by 140–180 scans (100 subjects) if there is evidence of over-fitting in the development of the algorithm.

‡Scans used in phase 3 training are scans that have been previously used in phases 1 and 2.

HV, Healthy Volunteer; iTIMM, Image-guided Theranostics in Multiple Myeloma; MM, Multiple Myeloma.