Use of 55 PET radiotracers under approval of a Radioactive Drug Research Committee (RDRC)

Jackson, Isaac M.; Lee, So Jeong; Sowa, Alexandra R.; Rodnick, Melissa E.; Bruton, Laura; Clark, Mara; Preshlock, Sean; Rothley, Jill; Rogers, Virginia E.; Botti, Leslie E.; Henderson, Bradford D.; Hockley, Brian G.; Torres, Jovany; Raffel, David M.; Brooks, Allen F.; Frey, Kirk A.; Kilbourn, Michael R.; Koeppe, Robert A.; Shao, Xia; Scott, Peter J. H.

doi:10.1186/s41181-020-00110-z

EJNMMI Radiopharmacy and Chemistry

Table 2 Dosing information

From: Use of 55 PET radiotracers under approval of a Radioactive Drug Research Committee (RDRC)

Radiotracer	Injected Dose (MBq)	Mass dose limit	Number of subjects scanned	Clinically detectable pharmacological effects in humans
[¹¹C]Radiotracers
[¹¹C]ACE	740	None	475	No
[¹¹C]ACHC	740	≤5000 μg/subject	2	No
[¹¹C]BMP	444	≤4625 μg/subject	65	No
[¹¹C]BUT	555	≤125 μg/kg	0^a	a
[¹¹C]CFN	555	≤0.03 μg/kg	1492	No
[¹¹C]CHO	592	None	44	No
[¹¹C]DASB	666	≤8 μg/subject	179	No
[¹¹C]DTBZ	555	≤50 μg/subject	1823	No
[¹¹C]EPI	740	< 9 μg/subject epinephrine & ≤1 μg/subject norepinephrine precursor	96	No
[¹¹C]FMZ	370	≤50 μg/subject	668	No
[¹¹C]HED	666	≤50 μg/subject^b	643	No
[¹¹C]LY2795050	555	≤10 μg/subject	0^c	c
[¹¹C]MET	444	None	129	No
[¹¹C]MTBZ	580	≤10 μg/subject	6	No
[¹¹C]MPH	666	≤25 μg/subject	170	No
[¹¹C]NMBP	740–1480	≤127 μg/subject^d	59	No
[¹¹C]OMAR	666	0.14 μg/kg	0^e	e
[¹¹C]PALM	740	None	8	No
[¹¹C]PBR28	666	≤10 μg/subject	34	No
[¹¹C]PiB	666	≤13 μg/subject	592	No
[¹¹C]PE2I	555	≤6.3 μg/subject	1	No
[¹¹C]PHEN	740	≤6800 μg/subject	29	No
[¹¹C]PK11195	888	≤420 μg/subject	118	No
[¹¹C]PMP	555	≤200 μg/subject	801	No
[¹¹C]RAC	555	≤50 μg/subject	627	No
[¹¹C]Ro-54,864	555	≤160 μg/subject	6	No
[¹¹C]SARC	592	None	20	No
[¹¹C]SCOP	1480	≤50 μg/subject	14	No
[¹¹C]TBZ	1018	≤10 μg/subject	2	No
[¹¹C]TRB	1110	≤31 μg/subject	26	No
[¹¹C]WAY-100365	555	≤15 μg/subject	51	No
[¹⁸F]Radiotracers
[¹⁸F]AV1451	370	≤20 μg/subject	92	No
[¹⁸F]ASEM	370	≤0.67 μg/subject	1	No
Auxumin	370	≤20 μg/subject	228^f	No
[¹⁸F]FAZA	296	≤3.5 μg/subject	14	No
[¹⁸F]FDG	185–296	None	6804	No
[¹⁸F]FDOPA	148	≤15 μg/subject	0^g	g
[¹⁸F]FEOBV	296	≤1.23 μg/subject	308	No
[¹⁸F]FCH	222	≤100 μg/subject	67	No
Amyvid	370	≤50 μg/subject	222	No
[¹⁸F]FLT	370	≤20 μg/subject	8	No
[¹⁸F]FLBT	296	≤0.02 μg/kg	92	No
Vizamyl	370	≤20 μg/subject	11	No
[¹⁸F]FMISO	370	≤15 μg/subject	8	No
[¹⁸F]FP-TBZ	370	≤7.5 μg/subject	23	No
[¹⁸F]GBR	148	≤900 μg/subject	2	No
[¹⁸F]MHPG	241	≤10 μg/subject	17	No
[¹⁸F]MPPF	259	≤2 μg/subject	34	No
[¹⁸F]NaF	222	None	9	No
[¹⁸F]NML	370	≤10 μg/subject	6	No
[¹⁸F]PHPG	241	≤10 μg/subject	15	No
Other Radiotracers
[¹³N]NH₃	740	None	1472	No
[¹⁵O]Water	555	None	1153	No
NETSPOT	200	≤40 μg/subject	981^f	No
[⁶⁸Ga]PSMA-11	185	≤10 μg/subject	751^f	No

^a[¹¹C]Butanol is validated for clinical production but studies have not yet commenced. We do not expect clinically detectable pharmacological effects as the mass limit (≤125 μg/kg) was selected since it is 1000 times below the NOAEL (125 mg/kg, see: Wagner 2005); ^b combined mass of HED and metaraminol precursor must be ≤50 μg/subject; ^c [¹¹C]LY2795050 is validated for clinical production but studies have not yet commenced at UM. We do not expect clinically detectable pharmacological effects as the mass limit (≤10 μg/subject) has been used without significant adverse events at other institutions (see: Naganawa et al. 2015); ^d See published limits (Yoshida et al. 1998); ^e [¹¹C]OMAR is validated for clinical production but studies have not yet commenced at UM. We do not expect clinically detectable pharmacological effects as the mass limit (≤0.14 μg/kg) has been used without significant adverse events at other institutions (see: Wong et al. 2010); ^f Includes subjects numbers scanned for clinical care and research; ^g [¹⁸F]FDOPA is validated for clinical production but studies have not yet commenced. We do not expect clinically detectable pharmacological effects as the mass limit (≤15 μg/subject) is significantly less than administered masses historically used when employing the electrophilic synthesis of [¹⁸F]FDOPA (13 mg/62 kg subject, see: Chevalme et al. 2007)

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