Objectives

[68Ga]Ga-HBED-11-PSMA (PSMA) and [68Ga]Ga-

DOTA-tate (DOTAtate) are two well established

PET tracers for diagnostic and staging of prostate

cancer (PCa) and neuroendocrine tumours (NET)

respectively. In our department we have used a

Trasis AllinOne (AiO) synthesiser since late 2014 to

routinely produce [68Ga]Ga-DOTA-tate,

[18F]fluorocholine ([18F]FCH) and [68Ga]Ga-HBED-

11-PSMA. [18F]FCH was initially produced for a

comparative clinical trial to demonstrate the

superiority of [68Ga]Ga-HBED-11-PSMA compared

to [18F]FCH in diagnostic and staging of PCa[1]. In

order to produce this range of radiolabelled

compounds, a versatile, reliable, cassette based

synthesizer was required.

Results

• [18F]FCH was produced in 21 % radioactivity

yield (average from 41 production runs) within

45 min (time between [18F]F- transfer to

synthesizer and product activity measurement.

For [18F]FCH production runs, radioactivity yields

were calculated from the delivered starting

activity of [18F]F-.

• Average radioactivity yield, radiochemical yield

(RCY), and labelling efficiency for [68Ga]Ga-

HBED-11-PSMA and [68Ga]Ga-DOTA-tate are

displayed in graphs 1 and 2 on the right for

different prepurification methods used. The

activity yields given are an estimate based on

the activity eluted rinsing the generator(s) at the

beginning of a week. For gallium-68 labelling

reactions, labelling efficiencies were calculated

based on the amount of product as a percentage

of the total amount of radioactivity recovered at

the end of synthesis (waste vial and sterile filter).

• Table 1 lists synthesis times and number of

patient runs for [68Ga]Ga-HBED-11-PSMA and

[68Ga]Ga-DOTA-tate. Synthesis times are

calculated from the time of generator elution to

the time of product activity measurement.

Methods

[18F]FCH was produced utilising 18 actuators in the

top row of the AiO synthesiser. The 68Ga-labelled

compounds were synthesised using the first six

actuators in each row.

Both 68Ga-complexed compounds were initially

produced with a method using anionic

prepurification of the 68Ge/68Ga-generator eluate.

Early in 2016 the routine synthesis process was

changed to a method without prepurification to

shorten synthesis time. Since mid-2016 a process

using cationic prepurification has been

implemented. Only taking a few minutes longer

than the process without prepurification, this

method allows for efficient prepurification of the

eluate as well as the elution of multiple generators

in parallel.

All methods have product purification using a HLB

cartridge in common. The product is then sterile

filtered into the product vial.

Labelling efficiencies and radioactivity yields for

different products and generator eluate

prepurification methods used are tabulated below

(cf results).

• Typical QC results for [68Ga]Ga-HBED-11-PSMA

and [68Ga]Ga-DOTA-tate, formulated as an

injectable sterile saline solution containing ~ 5 %

ethanol were as follows:

pH 5.5

DOTAtate RCP by TLC > 95 %

DOTAtate RCP by HPLC > 96 %

PSMA RCP by HPLC > 97 %

Conclusion

Over a period of more than two years, the AiO

synthesizer has been used for over 530 [68Ga]Ga-

HBED-11-PSMA, over 140 [68Ga]Ga-DOTA-tate,

and over 45 [18F]FCH synthesis.

Product quality and yield have been reproducible

and the synthesiser has proven to be very reliable

for automated routine production in a clinical

environment.

References

[1] J. Morigi et al., The Journal of Nuclear Medicine 2015,

Vol. 56 No. 8, 1185-1190

Use of a Trasis AllinOne Synthesizer for routine clinical production of [68Ga]Ga-HBED-11-PSMA

and [68Ga]Ga-DOTA-tate and [18F]fluorocholineD. Stark1 and T. Vergote2

1St. Vincent's Public Hospital Sydney Diagnostics Services Department - Nuclear Medicine and PET, Darlinghurst, Australia; 2Trasis SA, Ans, Belgium

Trasis Supervision

user interface.

Schematics of

synthesiser layout

visible on right.

Layout for process

with cationic

prepurification and

use of two

generators eluted in

parallel.

Graph 1 (left):

Labelling efficiency.

Graph 2 (right):

Radioactivity yield and

Radiochemical Yield

(RCY).

Table 1:

Synthesis times

and patient run

numbers for 68Ga-

labelled

compounds.

Product Method n (2015 / 2106) Synthesis Time

[68Ga]Ga-DOTA-tateanionic 51 / 15 32 min

without 0 / 32 20 min

[68Ga]Ga-HBED-11-PSMAanionic 262 / 76 32 min

without 0 / 174 20 min

cationic 0 / 16 23 min

40

54

35

53

73

59

51

56

69

48

73

89

75

70

0

10

20

30

40

50

60

70

80

90

100

anionic without cationic anionic

Radioactivity Yiled and Radiochemical Yield (RCY)

DOTA (Radioactivity Yield) PSMA (Radioactivity Yield) DOTA (RCY) PSMA (RCY)

2016 2015

%

72

85

71

95

99

91 90

0

10

20

30

40

50

60

70

80

90

100

anionic without cationic anionic

Labelling Efficiency DOTA PSMA

20152016

%